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Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

NCT01438814 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 689

Last updated 2014-11-25

Study results available
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Summary

The aim of this study is to investigate the impact of the combination therapy of linagliptin and metformin at submaximal doses in reduction of Glycosylated haemoglobin (HbA1c) and metformin pre-specified gastro-intestinal (GI) side effects in treatment naive patients of with type 2 diabetes mellitus.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

metformin placebo

metformin placebo tablets 500mg

DRUG

linagliptin placebo

linagliptin placebo tablets 5mg

DRUG

metformin

metformin tablets 500mg

DRUG

metformin

metformin tablets 500 mg

DRUG

linagliptin

linagliptin tablets 5mg

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
2011-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Bangladesh
  • Belgium
  • Canada
  • China
  • Germany
  • Guatemala
  • Hong Kong
  • India
  • Lebanon
  • Mexico
  • Peru
  • Philippines
  • 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 NCT01438814 on ClinicalTrials.gov