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Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone

NCT00641043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2014-02-17

Study results available
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Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

placebo + pioglitazone (30 mg)

placebo + overcapsulated 30 mg tablet, once daily

DRUG

Linagliptin + pioglitazone (30 mg)

5 mg tablet + overcapsulated 30 mg tablet, once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-06-30

Countries

  • Austria
  • Greece
  • Hungary
  • Japan
  • Portugal
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

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 NCT00641043 on ClinicalTrials.gov