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Last Updated: November 24, 2020

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CLINICAL TRIALS PROFILE FOR AMARYL

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505(b)(2) Clinical Trials for Amaryl

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00151697 LANN-study: Lantus, Amaryl, Novorapid, Novomix Study Completed Rijnstate Hospital Phase 3 2005-05-01 Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Amaryl

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00044447 Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione Completed Sanofi Phase 3 2001-05-01 The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.
NCT00131664 Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study) Completed GlaxoSmithKline Phase 3 2005-09-01 The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00131664 Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study) Completed Canadian Heart Research Centre Phase 3 2005-09-01 The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.
NCT00151697 LANN-study: Lantus, Amaryl, Novorapid, Novomix Study Completed Rijnstate Hospital Phase 3 2005-05-01 Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
NCT00258804 Insulin Glargine During and After the Period of Fasting in Ramadan Completed Sanofi Phase 4 2005-05-01 Primary Objectives : - To compare the number of hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) in patients with type 2 diabetes treated with insulin glargine (Lantus®) and glimepiride (Amaryl®), before, during and after the period of fasting in Ramadan. Secondary Objectives : - To assess glycaemic control before, during and after Ramadan in terms of HbA1c, FBG, and 8-point blood glucose profile (FBG and 8-point blood glucose profile will be collected with a blood glucose monitor through a monthly patient diary). - To assess the relationship between hypoglycaemia events during Ramadan and blood glucose control prior and during Ramadan. - To assess patient satisfaction - To document adverse events (all serious adverse events, non serious adverse events) throughout the study (all events will be collected through the monthly patient diary).
NCT00294723 To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c Terminated Novo Nordisk A/S Phase 3 2006-02-01 This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).
NCT00437554 Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR) Completed Handok Pharmaceuticals Co., Ltd. Phase 3 2006-08-01 Primary: To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM) Secondary: To compare the following parameters in two treatment arm - Efficacy; Fasting Plasma Glucose (FPG) and Post-prandial two hours plasma glucose (PP2h) - Response rates in terms of HbA1c, FPG - Patient compliance Safety: - episodes of hypoglycemia - adverse events - laboratory values including hematology blood chemistry and urinalysis - vital sign and physical examination
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amaryl

Condition Name

Condition Name for Amaryl
Intervention Trials
Type 2 Diabetes Mellitus 12
Healthy 11
Diabetes Mellitus, Type 2 7
Type 2 Diabetes 3
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Condition MeSH

Condition MeSH for Amaryl
Intervention Trials
Diabetes Mellitus 26
Diabetes Mellitus, Type 2 25
Albuminuria 1
Glucose Intolerance 1
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Clinical Trial Locations for Amaryl

Trials by Country

Trials by Country for Amaryl
Location Trials
United States 47
Germany 15
Korea, Republic of 8
Italy 8
India 7
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Trials by US State

Trials by US State for Amaryl
Location Trials
Texas 8
North Dakota 3
California 2
Utah 2
Pennsylvania 2
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Clinical Trial Progress for Amaryl

Clinical Trial Phase

Clinical Trial Phase for Amaryl
Clinical Trial Phase Trials
Phase 4 14
Phase 3 10
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Amaryl
Clinical Trial Phase Trials
Completed 33
Recruiting 5
Terminated 3
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Clinical Trial Sponsors for Amaryl

Sponsor Name

Sponsor Name for Amaryl
Sponsor Trials
Sanofi 8
Handok Pharmaceuticals Co., Ltd. 6
Takeda 4
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Sponsor Type

Sponsor Type for Amaryl
Sponsor Trials
Industry 36
Other 9
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