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Last Updated: February 3, 2023

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
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.
>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 22
Diabetes Mellitus, Type 2 12
Healthy 11
Type 2 Diabetes 9
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Condition MeSH

Condition MeSH for Amaryl
Intervention Trials
Diabetes Mellitus 47
Diabetes Mellitus, Type 2 47
Malnutrition 2
Disease 1
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Clinical Trial Locations for Amaryl

Trials by Country

Trials by Country for Amaryl
Location Trials
United States 87
Germany 19
Korea, Republic of 18
Italy 16
Mexico 12
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Trials by US State

Trials by US State for Amaryl
Location Trials
Texas 11
Illinois 4
California 4
Pennsylvania 4
New Jersey 4
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Clinical Trial Progress for Amaryl

Clinical Trial Phase

Clinical Trial Phase for Amaryl
Clinical Trial Phase Trials
Phase 4 24
Phase 3 21
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Amaryl
Clinical Trial Phase Trials
Completed 52
Terminated 8
Unknown status 5
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Clinical Trial Sponsors for Amaryl

Sponsor Name

Sponsor Name for Amaryl
Sponsor Trials
Sanofi 9
Merck Sharp & Dohme Corp. 8
Takeda 7
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Sponsor Type

Sponsor Type for Amaryl
Sponsor Trials
Industry 73
Other 38
NIH 2
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