Skip to main content
OpenTrials
Completed

NCT Number: NCT00309608

Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

1218.6.3302A Boehringer Ingelheim Investigational Site, Joué Les Tours, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion_Criteria:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus and previo usly treated with metformin alone or with metformin and one other oral antidiabetic d rug
  • HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
  • HbA1c 7.5 10.0% at screening for patients treated with metformin alone
  • HbA1c 7.5 10.0% at beginning of the placebo run-in phase
  • Age > 21 and < 75 years
  • MI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion criteria

Exclusion_Criteria:

  • Clinically relevant cardiovascular disease
  • Impaired hepatic function
  • Renal insufficiency or impaired renal function
  • Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  • Treatment with insulin within 3 months prior to screening

Treatment and study plan

Linagliptin

Drug

Linagliptin medium dose tablet once daily

Placebo

Drug

Placebo tablets once daily

Glimepiride

Drug

Glimepiride tablets once daily

Primary outcomes

  1. HbA1c Change From Baseline at Week 12

    Time frame: Baseline and week 12

    HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the HbA1c percent baseline value. Means are treatment adjusted for baseline HbA1c.

Secondary outcomes

  1. Percentage of Patients With HbA1c<=7.0% at Week 12

    Time frame: week 12

    Descriptive calculation of Patients with HbA1c <= 7.0% at Week 12.

  2. Fasting Blood Plasma Glucose Level (FPG) Change From Baseline at Week 12

    Time frame: Baseline and week 12

    This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.

Important dates

Study start
2006
Primary completion
2007
First posted
Apr 3, 2006
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.