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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR GLIMEPIRIDE


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505(b)(2) Clinical Trials for Glimepiride

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 Glimepiride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00032487 ↗ Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) Completed National Eye Institute (NEI) Phase 3 2000-12-01 This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗ Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) Completed SmithKline Beecham Phase 3 2000-12-01 This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗ Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) Completed VA Office of Research and Development Phase 3 2000-12-01 This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
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.
NCT00095030 ↗ Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone Completed Merck Sharp & Dohme Corp. Phase 3 2004-02-01 The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.
NCT00095030 ↗ Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone Completed Bristol-Myers Squibb Phase 3 2004-02-01 The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glimepiride

Condition Name

Condition Name for Glimepiride
Intervention Trials
Diabetes Mellitus, Type 2 71
Type 2 Diabetes Mellitus 70
Type 2 Diabetes 25
Diabetes 18
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Condition MeSH

Condition MeSH for Glimepiride
Intervention Trials
Diabetes Mellitus, Type 2 185
Diabetes Mellitus 178
Hypoglycemia 4
Cardiovascular Diseases 3
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Clinical Trial Locations for Glimepiride

Trials by Country

Trials by Country for Glimepiride
Location Trials
United States 725
Germany 78
Canada 77
India 62
United Kingdom 61
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Trials by US State

Trials by US State for Glimepiride
Location Trials
Texas 38
California 33
Florida 32
Ohio 25
South Carolina 24
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Clinical Trial Progress for Glimepiride

Clinical Trial Phase

Clinical Trial Phase for Glimepiride
Clinical Trial Phase Trials
Phase 4 71
Phase 3 93
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Glimepiride
Clinical Trial Phase Trials
Completed 175
Terminated 22
Unknown status 17
[disabled in preview] 12
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Clinical Trial Sponsors for Glimepiride

Sponsor Name

Sponsor Name for Glimepiride
Sponsor Trials
Merck Sharp & Dohme Corp. 31
Sanofi 21
Novo Nordisk A/S 17
[disabled in preview] 37
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Sponsor Type

Sponsor Type for Glimepiride
Sponsor Trials
Industry 220
Other 114
NIH 4
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