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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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Clinical Trials for Linagliptin; Metformin Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00309608 Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes Completed Boehringer Ingelheim Phase 2 The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
NCT00601250 Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes Completed Boehringer Ingelheim Phase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
NCT00602472 BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes Completed Boehringer Ingelheim Phase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00798161 Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design Completed Boehringer Ingelheim Phase 3 The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
NCT00915772 Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid Completed Boehringer Ingelheim Phase 3 A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
NCT00996658 Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone Completed Eli Lilly and Company Phase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00996658 Linagliptin Versus Placebo in Type 2 Diabetic Patients With Inadequate Glycaemic Control on Metformin in Combination With Pioglitazone Completed Boehringer Ingelheim Phase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Linagliptin; Metformin Hydrochloride

Condition Name

Condition Name for Linagliptin; Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 20
Healthy 16
Type 2 Diabetes Mellitus 3
Type 2 Diabetes 3
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Condition MeSH

Condition MeSH for Linagliptin; Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 29
Diabetes Mellitus, Type 2 28
Insulin Resistance 2
Prediabetic State 2
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Clinical Trial Locations for Linagliptin; Metformin Hydrochloride

Trials by Country

Trials by Country for Linagliptin; Metformin Hydrochloride
Location Trials
United States 130
Canada 45
Germany 18
Australia 14
Russian Federation 9
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Trials by US State

Trials by US State for Linagliptin; Metformin Hydrochloride
Location Trials
Texas 9
Georgia 8
Florida 8
California 7
South Carolina 6
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Clinical Trial Progress for Linagliptin; Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Linagliptin; Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 13
Phase 3 14
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Linagliptin; Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 31
Recruiting 7
Active, not recruiting 4
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Clinical Trial Sponsors for Linagliptin; Metformin Hydrochloride

Sponsor Name

Sponsor Name for Linagliptin; Metformin Hydrochloride
Sponsor Trials
Boehringer Ingelheim 38
Eli Lilly and Company 19
Marcus Borchert 1
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Sponsor Type

Sponsor Type for Linagliptin; Metformin Hydrochloride
Sponsor Trials
Industry 62
Other 24
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