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Serving leading biopharmaceutical companies globally:

US Army
McKesson
Boehringer Ingelheim
Accenture
Healthtrust
Dow
Farmers Insurance
Daiichi Sankyo
Express Scripts
Colorcon

Generated: January 24, 2018

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
LINAGLIPTIN

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00309608 Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 DiabetesCompletedBoehringer IngelheimPhase 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.
NCT00328172 Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes PatientsCompletedBoehringer IngelheimPhase 2 The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
NCT00601250 Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 DiabetesCompletedBoehringer IngelheimPhase 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 DiabetesCompletedBoehringer IngelheimPhase 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.
NCT00621140 Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic ControlCompletedBoehringer IngelheimPhase 3 To investigate efficacy, safety and tolerability of BI 1356 versus placebo
NCT00641043 Efficacy vs Placebo as Initial Combination Therapy With PioglitazoneCompletedBoehringer IngelheimPhase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00654381 Japanese P III vs Voglibose and PlaceboCompletedBoehringer IngelheimPhase 3 The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
NCT00716092 The Effect of Linagliptin (BI 1356) on 24h-glucose Control and Various Biomarkers in Type 2 Diabetic PatientsCompletedBoehringer IngelheimPhase 2 The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
NCT00736099 Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DMCompletedBoehringer IngelheimPhase 3 The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment. The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)
NCT00740051 A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is InappropriateCompletedBoehringer IngelheimPhase 3 Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
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Conditions

Condition Name

Condition Name for linagliptin
Intervention Trials
Diabetes Mellitus, Type 2 47
Healthy 25
Type 2 Diabetes 10
Type 2 Diabetes Mellitus 7
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Condition MeSH

Condition MeSH for linagliptin
Intervention Trials
Diabetes Mellitus 68
Diabetes Mellitus, Type 2 68
Renal Insufficiency 6
Insulin Resistance 3
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Trial Locations

Trials by Country

Trials by Country for linagliptin
Location Trials
United States 378
Canada 86
Germany 35
Australia 27
Italy 23
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Trials by US State

Trials by US State for linagliptin
Location Trials
Texas 24
California 21
Florida 21
South Carolina 17
Georgia 16
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for linagliptin
Clinical Trial Phase Trials
Phase 4 29
Phase 3 37
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for linagliptin
Clinical Trial Phase Trials
Completed 68
Recruiting 17
Active, not recruiting 10
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for linagliptin
Sponsor Trials
Boehringer Ingelheim 73
Eli Lilly and Company 35
American Diabetes Association 2
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Sponsor Type

Sponsor Type for linagliptin
Sponsor Trials
Industry 126
Other 56
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Medtronic
Colorcon
Teva
Covington
Deloitte
QuintilesIMS
Julphar
US Department of Justice
Argus Health

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