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Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients

NCT00328172 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2014-03-14

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo matching BI 1356

DRUG

BI 1356 dose 3 once daily

BI 1356 dose 3 once daily

DRUG

BI 1356 dose 2 once daily

BI 1356 dose 2 once daily

DRUG

BI 1356 dose 1 once daily

BI 1356 dose 1 once daily

DRUG

Metformin

Metformin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-08-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00328172 on ClinicalTrials.gov