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Glimepiride Metformin Fixed Dose Combination

Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers

Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers

Jung, S., Chae, J., Song, B., Kwon, K. (2014). Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iranian Journal of Pharmaceutical Research, 13(2), 365-371. Sang-hoon Jung; Jung-woo Chae; Byung-jeong Song; Kwangil Kwon. "Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers". Iranian Journal of Pharmaceutical Research, 13, 2, 2014, 365-371. Jung, S., Chae, J., Song, B., Kwon, K. (2014). 'Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers', Iranian Journal of Pharmaceutical Research, 13(2), pp. 365-371. Jung, S., Chae, J., Song, B., Kwon, K. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iranian Journal of Pharmaceutical Research, 2014; 13(2): 365-371. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers College of Pharmacy, Chungnam National University Glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin(2/500mg) fixed-dose combination(FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers. This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40male Continue reading >>

Efficacy And Safety Of The Fixed Dose Combination Of Glimepiride+metformin In Type 2 Diabetic Patients Inadequately Controlled (legend)

Efficacy And Safety Of The Fixed Dose Combination Of Glimepiride+metformin In Type 2 Diabetic Patients Inadequately Controlled (legend)

Percentage of patients with HbA1c < 7% [TimeFrame:at week 24] Percentage of patients with HbA1c < 6.5% [TimeFrame:at week 24] Change in Fasting Plasma Glucose (FPG) [TimeFrame:from baseline to week 24] Number of patients with adverse events [TimeFrame:over the 24-week treatment period] Hypoglycemia [TimeFrame:over the 24-week treatment period] Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry. Signed informed consent, obtained prior any study procedure Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit. Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations Continue reading >>

Comparison Of The Efficacy And Safety Of Glimepiride/metformin Fixed Combination Versus Free Combination In Patients With Type 2 Diabetes: Multicenter, Randomized, Controlled Trial

Comparison Of The Efficacy And Safety Of Glimepiride/metformin Fixed Combination Versus Free Combination In Patients With Type 2 Diabetes: Multicenter, Randomized, Controlled Trial

Your browser does not support the NLM PubReader view. Go to this page to see a list of supporting browsers. Comparison of the Efficacy and Safety of Glimepiride/Metformin Fixed Combination Versus Free Combination in Patients with Type 2 Diabetes: Multicenter, Randomized, Controlled Trial J Korean Diabetes Assoc. 2006 Nov;30(6):466-475. J Korean Diabetes Assoc. 2006 Nov;30(6):466-475. Korean. Published online November 30, 2006. Copyright 2006 Korean Diabetes Association Comparison of the Efficacy and Safety of Glimepiride/Metformin Fixed Combination Versus Free Combination in Patients with Type 2 Diabetes: Multicenter, Randomized, Controlled Trial Seung-Hwan Lee,In-Kyu Lee,1Sei-Hyun Baik,2Dong-Seop Choi,3Kyong-Soo Park,4Ki-Ho Song,5Kwan-Woo Lee,6Bong-Soo Cha,7Chul-Woo Ahn,8Hyoung-Woo Lee,9Choon-Hee Chung,10Moon-Suk Nam,11Hong-Sun Baek,12Yong-Ki Kim,13Hyo-Young Rhim,14 and Ho-Young Son Kangnam St. Mary's hospital, The Catholic University of Korea, Korea. 1Keimyung University Medical Center, Korea. 4Seoul National University Hospital, Korea. 5St. Vincent Hospital, The Catholic University of Korea, Korea. 7Severance Hospital, Yonsei University, Korea. 8Yongdong Severance Hospital, Yonsei University, Korea. 9Yeongnam University Medical Center, Korea. 12Chonbuk National University Hospital, Korea. 13Pusan National Universtiy Hospital, Korea. 14Handok Pharmaceuticals Co., LTD., Korea. Received May 29, 2006; Accepted November 20, 2006. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care 1998;21:14141431. The Diabetes Control and Complication Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes Continue reading >>

Fixed-dose Combinations In Type 2 Diabetes Role Of The Canagliflozin Metformin Combination

Fixed-dose Combinations In Type 2 Diabetes Role Of The Canagliflozin Metformin Combination

Editor who approved publication: Professor Ming-Hui Zou Joshua W Fleming, Laurie W Fleming, Courtney S Davis Department of Pharmacy Practice, The University of Mississippi School of Pharmacy, Jackson, MS, USA Abstract: Canagliflozinmetformin is one of the newest combination therapies available for the treatment of type 2 diabetes mellitus (T2DM). Canagliflozin is an inhibitor of the sodiumglucose co-transporter 2 which causes an increase in the urinary excretion of glucose. In the present article, we review the safety and efficacy of canagliflozin and metformin from data obtained from Phase III metformin add-on therapy clinical trials as there are no studies to date that specifically evaluate the combination of metformin and canagliflozin. Trials included in this review were dual-therapy trials of subjects who were already taking background metformin and were assigned to receive canagliflozin, glimepiride, or sitagliptin. The addition of canagliflozin to metformin resulted in a decrease in HbA1c of 0.73%0.93%. Canagliflozin 100 mg was considered to be non-inferior to glimepiride and sitagliptin 100 mg with the canagliflozin 300 mg dose being statistically superior to sitagliptin and glimepiride. Other advantages of the use of canagliflozin are reduction in weight (3.34.0 kg) and systolic blood pressure (3.34.7 mmHg). The primary disadvantages are potential genital mycotic infections, hypotension, and gastrointestinal side effects from metformin. All things considered, this combination appears to be safe and effective in clinical trials and represents a promising option for the treatment of T2DM. Keywords: type 2 diabetes, fixed-dose combination (FDC), canagliflozin metformin This work is published and licensed by Dove Medical Press Limited. The full terms of this licen Continue reading >>

Efficacy Of Glimepiride/metformin Fixed-dose Combination Vs Metformin Uptitration In Type 2 Diabetic Patients Inadequately Controlled On Low-dose Metformin Monotherapy: A Randomized, Open Label, Parallel Group, Multicenter Study In Korea

Efficacy Of Glimepiride/metformin Fixed-dose Combination Vs Metformin Uptitration In Type 2 Diabetic Patients Inadequately Controlled On Low-dose Metformin Monotherapy: A Randomized, Open Label, Parallel Group, Multicenter Study In Korea

Go to: Abstract To compare the efficacy and safety of early combination therapy with glimepiride/metformin to metformin uptitration in reducing glycated hemoglobin (HbA1c) levels in Korean type 2 diabetic patients inadequately controlled on low-dose metformin monotherapy. In a randomized, open label, parallel group, multicenter study, 209 Korean type 2 diabetic patients (HbA1c 7.0–10.0%, on metformin 500–1,000 mg/day) received glimepiride/metformin fixed-dose combination (G/M FDC) or metformin uptitration treatment (Met UP). The primary end-point was the change in HbA1c from baseline to week 24. Results G/M FDC therapy provided significantly greater adjusted mean decreases vs Met UP therapy in HbA1c (−1.2 vs −0.8%, P < 0.0001), and fasting plasma glucose (−35.7 vs −18.6 mg/dL, P < 0.0001). A significantly greater proportion of patients with G/M FDC therapy achieved HbA1c < 7% (74.7 vs 46.6%, P < 0.0001) at the end of the study. More patients experienced hypoglycemia with G/M FDC therapy compared with Met UP therapy (41 vs 5.6%, P < 0.0001), but there was no serious hypoglycemia in any group. A modest increase in mean bodyweight occurred in the patients who were treated with G/M FDC therapy (1.0 kg), whereas a slight decrease was observed in the patients who were treated with Met UP therapy (−0.7 kg). The present study showed that glimepiride/metformin fixed-dose combination therapy was more effective in glycemic control than metformin uptitration, and was well tolerated in type 2 diabetic patients inadequately controlled by low-dose metformin monotherapy in Korea. This trial was registered with ClinicalTrial.gov (no. NCT00612144). Keywords: Glimepiride/metformin combination, Korea, Type 2 diabetes mellitus Go to: Type 2 diabetes mellitus is one of the most Continue reading >>

Sanofi Goes To High Court Over Indian Ban On Fixed Dose Combo Diabetes Drug

Sanofi Goes To High Court Over Indian Ban On Fixed Dose Combo Diabetes Drug

Sanofi has challenged an Indian Government decision banning the manufacture and sale of its fixed dose combination diabetes drug, Amaryl MP. Earlier this month, Indias Department of Health and Family Welfare issued a notification in its public journal the Gazette of India banning 344 fixed dose combination (FDC) drugs. Among the products banned was Sanofis Amaryl MP, used to lower and control the blood sugar levels in patients with type 2 diabetes, which comprises of the active ingredients glimepiride, metformin, and pioglitazone. The Government claiming that the use of the drug fixed dose combination is likely to involve risk to human beings whereas safer alternatives to the said drug are available. The notification continued: The Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug fixed dose combination of Glimepiride + Pioglitazone + Metformin with immediate effect. Sanofi India, however, is disputing the order. According to a letter submitted to the Bombay Stock Exchange (BSE) yesterday the firm filed a Writ Petition on March 19 in the Delhi High Court, which has delayed pursuing the impugned notification. Accordingly, the notification under which the Companys product Amaryl MP is sought to be covered, will not be enforced until 28th March 2016, Sanofi India said in its letter. The firm also said that if the ban on manufacture was to stand, the product will not have any material impact on the firms financial statements. The turnover of the said product constituted only around 0.40% of the turnover of the Company for the financial year ended 31st December 2015. In-Pharmatechnologist.com received no response from both Sanofi and Sanofi India on either the Writ, or the production of Amaryl MP. According to a Facebo Continue reading >>

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT01457911 Information provided by (Responsible Party): To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg). Fasting plasma glucose > 250 mg/dL (> 13.9 mmol/L) Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening The above information is not intended to contain all considerations relevant to a patient's potential partic Continue reading >>

Welcome To Journal Of The Association Of Physicians Of India

Welcome To Journal Of The Association Of Physicians Of India

Received: 29.05.2017; Accepted: 04.06.2017 Background: Conventionally, diabetes management involved targeting the triad of FPG, PPG, and HbA1c. However, several studies have suggested the quintessential need for a paradigm shift to incorporate glycemic variability and quality of life in the holistic diabetes control regimen. Aim: To generate a consensus and ratify the position of Glycemic Variability (GV) and Quality of Life (QOL), along with the traditional triad, in diabetes management in India. To evaluate whether the triple fixed dose combination of metformin, glimepiride, and voglibose can accomplish the goals of glycemic pentad. Methodology: Glycemic pentad forum was instituted comprising of 55 experts from different regions of India in the field of diabetology who discussed various evidences related to the topic and shared their experiences and expressed their opinion on the relevance of glycemic pentad in the present diabetes management and whether triple fixed dose combination of metformin, glimepiride, and voglibose is able to achieve glycemic pentad targets. Results: Forum has come to a consensus that the conglomerate of quintuple elements FPG, PPG, HbA1c, glycemic variability and quality of life to be termed as glycemic pentad and these milestones to be considered for any antidiabetic therapy. Experts opined that combination therapy is required to achieve the Glycemic Pentad, as monotherapy might not address all the five arms of Glycemic Pentad. Group also agreed that the diabetes management in Indians require separate attention due to their distinct dietary habits (high carbohydrate content) and socio-economic status (economically weak and poorly educated). Therefore, mild adjustments to the standard practices in the western countries are suggested. After Continue reading >>

Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers

Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers

Jung, S., Chae, J., Song, B., Kwon, K. (2014). Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iranian Journal of Pharmaceutical Research, 13(2), 365-371. Sang-hoon Jung; Jung-woo Chae; Byung-jeong Song; Kwangil Kwon. "Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers". Iranian Journal of Pharmaceutical Research, 13, 2, 2014, 365-371. Jung, S., Chae, J., Song, B., Kwon, K. (2014). 'Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers', Iranian Journal of Pharmaceutical Research, 13(2), pp. 365-371. Jung, S., Chae, J., Song, B., Kwon, K. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Iranian Journal of Pharmaceutical Research, 2014; 13(2): 365-371. Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers College of Pharmacy, Chungnam National University Glimepiride/metformin(2/500mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin(2/500mg) fixed-dose combination(FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers. This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40male Continue reading >>

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin glimepiride and metformin hydrochloride combination (hoe490), glimepiride (hoe490) - To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. - To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. - To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. - To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg). AMARYL M (Glimepiride and Metformin hydrochloride combination) AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal glimepiride and metformin hydrochloride combination (hoe490) Pharmaceutical form:tablet Route of administration: oral AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal Pharmaceutical form:tablet Route of administration: oral time frame:20 weeks, from baseline to week 20 Percentage of patients reaching HbA1c < 7% or HbA1c 6.5%, respectively Absolute change in Fasting Plasma Glucose time frame:20 weeks, from baseline to week 20 Number of patients reporting adverse events time frame:20 weeks, from baseline to week 20 Number of patient Continue reading >>

Ada 2017: Oral Agents Under Review

Ada 2017: Oral Agents Under Review

American Diabetes Association 77th Scientific Sessions, June 9-13, 2017, San Diego, CA Study 1. Metformin Association with Vitamin B12 Deficiency in Type 2 Diabetes (T2D) Patients: Dose-Response and Diet Assessment Study. Study 1. B12 deficiency related to dose and duration of metformin was not adequately compensated by dietary intake. Study 1. Conclusion: A targeted screening for B12 deficiency is warranted in patients taking metformin in dose of more than 2,000mg/day over a period of more than 4 years. Link to Abstract. Study 2. Comparison between Adherence to Glimepiride/Metformin Sustained Release Once-Daily vs Immediate-Release Twice-Daily Fixed Combination Therapy in Patient with Type 2 Diabetes Using an Electronic Medication Events Monitoring System: Randomized Controlled Study Study 2. Adherence with once-daily, sustained-release (SR) oral antidiabetic and twice-daily immediate-release (IR) was compared using an electronic medication events monitoring system. Study 2. Conclusion: Patient adherence with their antidiabetic regimen is a primary factor in optimal long-term treatment; adherence with the simpler once-daily dosing of a sustained-release combination agent was found to be significantly better than with twice daily immediate release. Link to Abstract. Study 3. Clinical Efficacy and Safety of Fixed-Dose Combination of Glimepiride and Metformin in Patients with Type 2 Diabetes Inadequately Controlled by Each Component Alone or Used as Free Combo Study 3. With the previous report of greater adherence to once-daily SR oral antidiabetic agents than with twice-daily IR agents, this study evaluates efficacy and safety of the fixed combination after inadequate control on each component alone or in free combination. Study 3. Conclusion: The fixed dose combination Continue reading >>

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches Of The Same Fixed Dose Combinations Amaryl M Ir 2/1000 (glimepiride/metformin Hydrochloride Immediate Release Combination Tablet) In Fed Conditions In Healthy Male And/or Female Subjects.

An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches Of The Same Fixed Dose Combinations Amaryl M Ir 2/1000 (glimepiride/metformin Hydrochloride Immediate Release Combination Tablet) In Fed Conditions In Healthy Male And/or Female Subjects.

FDA MHRA JSQA CRO List Clinical Trials Clinical Research Jobs An Open-label, Randomized, Two-treatment Crossover Bioequivalence Study Comparing Two Batches of the Same Fixed Dose Combinations Amaryl M IR 2/1000 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects. COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects. Jordan: Jordanian Food and Drug Administration The purpose of this study is to assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl M IR 2/1000) manufactured in India and in Turkey. An open-label, randomized, two-treatment crossover bioequivalence study comparing two batches of the same fixed dose combinations Amaryl M IR 2/1000 (glimepiride/metformin hydrochloride immediate release combination tablet) in fed conditions in healthy male and/or Primary Objective To assess, after single oral administration under fed conditions, the bioequivalence between the two batches of the same glimepiride/metformin hydrochloride (HCl) 2 mg/1000 mg fixed dose combination (FDC) tablets (immediate release combination tablet Amaryl M IR 2/1000) manufactured in India and in Turkey. Secondary Objective(s) To assess the safety (including hypoglycemic events) of the two FDC Up to 50 healthy subjects are to be enrolled to have 46 subjects available for the final In each period A single dose of glimepiride/metformin HCl 2mg/1000 mg FDC (manufactured in India) Or Continue reading >>

Efficacy Of Glimepiride/metformin Fixed-dose Combination Vs Metformin Uptitration In Type 2 Diabetic Patients Inadequately Controlled On Low-dose Metformin Monotherapy: A Randomized, Open Label, Parallel Group, Multicenter Study In Korea.

Efficacy Of Glimepiride/metformin Fixed-dose Combination Vs Metformin Uptitration In Type 2 Diabetic Patients Inadequately Controlled On Low-dose Metformin Monotherapy: A Randomized, Open Label, Parallel Group, Multicenter Study In Korea.

Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine Seoul, Korea. To compare the efficacy and safety of early combination therapy with glimepiride/metformin to metformin uptitration in reducing glycated hemoglobin (HbA1c) levels in Korean type2 diabetic patients inadequately controlled on low-dose metformin monotherapy. In a randomized, open label, parallel group, multicenter study, 209 Korean type2 diabetic patients (HbA1c 7.0-10.0%, on metformin 500-1,000mg/day) received glimepiride/metformin fixed-dose combination (G/M FDC) or metformin uptitration treatment (Met UP). The primary end-point was the change in HbA1c from baseline to week24. G/M FDC therapy provided significantly greater adjusted mean decreases vs Met UP therapy in HbA1c (-1.2 vs -0.8%, P<0.0001), and fasting plasma glucose (-35.7 vs -18.6mg/dL, P<0.0001). A significantly greater proportion of patients with G/M FDC therapy achieved HbA1c<7% (74.7 vs 46.6%, P<0.0001) at the end of the study. More patients experienced hypoglycemia with G/M FDC therapy compared with Met UP therapy (41 vs 5.6%, P<0.0001), but there was no serious hypoglycemia in any group. A modest increase in mean bodyweight occurred in the patients who were treated with G/M FDC therapy (1.0kg), whereas a slight decrease was observed in the patients who were treated with Met UP therapy (-0.7kg). The present study showed that glimepiride/metformin fixed-dose combination therapy was more effective in glycemic control than metformin uptitration, and was well tolerated in type2 diabetic patients inadequately controlled by low-dose metformin monotherapy in Korea. This trial was registered with ClinicalTrial.gov (no. NCT00612144 ). Glimepiride/metformin combination; Korea; Type 2 diabet Continue reading >>

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Patients With Type 2 Diabetes. Results Of Russian Observational Study

Evaluation Of Fixed Dose Combination Of Glimepiride And Metformin In Patients With Type 2 Diabetes. Results Of Russian Observational Study

Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study Authors: Zaytseva N.V., Jarek-Martynova I.R. To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM). A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial blood glucose (PPG) levels; weight; waist circumference and hypoglycemic episodes were evaluated. Baseline HbA1c levels (8.24% ? 0.42%) were significantly reduced after 12 weeks of treatment (7.48% ? 0.48%) and at the end of the study. (6.88% ? 0.56%). Target HbA1c levels (?7%) were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ? 1.14 mmol/l and 2.17 ? 1.27 mmol/l respectively (p < 0.001). No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ? 1.28 kg/m2 (p < 0.001). Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks. without additional risk of hypoglycemic events or weight gain. C 2 (2) , . 2 , . , 2 - . 2 , [1]. , , , , , [2]. 2 ( ) - . 2 , , - . 2 . () 2015 . 2 [3]. 7- [4]. 2015 . ADA/EASD (American Diabetes Association/ European Association for the Study of Diabetes), 2 [5]. , , , (HbA1c) (). , , 2: , . 2 , . . , 2 , 2. -4, -1. , 6 HbA1c 0,5%, . . (HbA1c), 2, , , . . (IDF International Diabetes Federation, 2012) [6], ADA (2014) [7], (2011) [3], (ADVANCE Action in Diabetes and V Continue reading >>

Ebscohost | 96426544 | Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers.

Ebscohost | 96426544 | Bioequivalence Comparison Of Two Formulations Of Fixed-dose Combination Glimepiride/metformin (2/500 Mg)tablets In Healthy Volunteers.

Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers. Source: Iranian Journal of Pharmaceutical Research . Spring2014, Vol. 13 Issue 2, p365-371. 7p. Author(s): Sang-hoon Jung; Jung-woo Chae; Byung-jeong Song; Kwang-il Kwon Abstract: Glimepiride/metformin (2/500 mg) is an oral antihyperglycemic agent for the treatment of type 2 diabetes. A generic glimepiride/metformin (2/500 mg) fixed-dose combination (FDC) tablet was developed recently. This study was designed to collect data for submission to Korean regulatory authorities to allow the marketing of the test formulation. We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy male adult volunteers.This single-dose, randomized, double-blind, two-way crossover trial was conducted at Bestian Medical Center in Bucheon, Korea. In total, 40 male Korean volunteers were enrolled. The subjects were randomized to receive an FDC tablet containing the glimepiride/metformin (2/500 mg) test or reference formulation, and pharmacokinetic(PK) parameters were measured. After a 1-week washout period, the other formulation was administered and the PK parameters were measured again. The Cmax and AUCt were determined from blood samples obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 h after drug administration. Bioequivalence was considered established if the 90% CIs of the geometric mean ratios(GMRs) of the test-to-reference formulations for Cmax and AUCt were within the predetermined regulatory range of 80-125%. Intotal, 40 healthy male subjects were enrolled and completed the study (mean [SD] age, 23.2[2.26]years[range, 19-30years];weight, Continue reading >>

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