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Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes | Clinical Trials | Clareo Health

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Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

NCT00601250•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
•2. Diagnosis of type 2 diabetes prior to informed consent
•3. Glycosylated haemoglobin A1 (HbA1c)at screening:
•For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
•4. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
•5. Age 18 -80 years
•6. BMI (Body Mass Index) less than 40 kg/m2
•7. Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion Criteria

•1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
•2. Impaired hepatic function
•3. Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
•4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
•5. Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
•6. Treatment with insulin within 3 months prior to informed consent
•7. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
•8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
•9. Participation in another trial with an investigational drug within 2 months prior to informed consent
•10. Pre-menopausal women who:
+7 more criteria

Locations (82)

1218.17.10003 Boehringer Ingelheim Investigational Site

Chula Vista, California, United States

1218.17.10014 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

1218.17.10001 Boehringer Ingelheim Investigational Site

Walnut Creek, California, United States

1218.17.10021 Boehringer Ingelheim Investigational Site

Northglenn, Colorado, United States

1218.17.10010 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

1218.17.10011 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

1218.17.10008 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

1218.17.10017 Boehringer Ingelheim Investigational Site

Gurnee, Illinois, United States

1218.17.10006 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

1218.17.10012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Key Dates

Start Date

January 1, 2008

Primary Completion Date

May 1, 2009

Last Updated

January 28, 2014

Enrollment

701

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

linagliptin

DRUG

linagliptin

DRUG

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Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

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RECRUITINGNA

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Diabetes Mellitus, Type 2Depressive Symptoms+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Glycemic Control and Cardiovascular Disease Risk in Patients With Type 2 Diabetes

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Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes

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