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Last Updated: December 12, 2019

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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.
>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 63
Type 2 Diabetes Mellitus 52
Type 2 Diabetes 22
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Condition MeSH

Condition MeSH for Glimepiride
Intervention Trials
Diabetes Mellitus, Type 2 155
Diabetes Mellitus 154
Hypoglycemia 4
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Clinical Trial Locations for Glimepiride

Trials by Country

Trials by Country for Glimepiride
Location Trials
United States 658
Germany 72
Canada 68
United Kingdom 52
Mexico 52
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Trials by US State

Trials by US State for Glimepiride
Location Trials
Texas 34
California 30
Florida 28
Ohio 23
Arizona 22
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Clinical Trial Progress for Glimepiride

Clinical Trial Phase

Clinical Trial Phase for Glimepiride
Clinical Trial Phase Trials
Phase 4 57
Phase 3 78
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Glimepiride
Clinical Trial Phase Trials
Completed 128
Recruiting 20
Terminated 14
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Clinical Trial Sponsors for Glimepiride

Sponsor Name

Sponsor Name for Glimepiride
Sponsor Trials
Merck Sharp & Dohme Corp. 19
Novo Nordisk A/S 16
Sanofi 16
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Sponsor Type

Sponsor Type for Glimepiride
Sponsor Trials
Industry 173
Other 94
NIH 3
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