MedTrace Logo

Safety and Efficacy of Linagliptin in Type-2-diabetes Mellitus Patients With Moderate to Severe Renal Impairment

NCT01087502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2014-06-27

Study results available
· View outcomes & findings →

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Glimepiride

1-4 mg daily after 12 weeks

DRUG

Placebo

Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily

DRUG

Placebo

Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment

DRUG

Placebo

Placebo mach to 5 mg linagliptin once daily after 12 weeks

DRUG

Linagliptin

5 mg 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-05-31

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • Israel
  • Japan
  • New Zealand
  • Slovakia
  • Sweden

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 NCT01087502 on ClinicalTrials.gov