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Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

NCT00954447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1263

Last updated 2013-12-30

Study results available
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Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Placebo, identical to Linagliptin tablet

DRUG

Linagliptin

intended final marketed dose

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-09-30

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • Finland
  • Germany
  • Greece
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Peru
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Taiwan

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 NCT00954447 on ClinicalTrials.gov