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Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

NCT01512979 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2014-05-20

Study results available
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Summary

The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

metformin

1000 mg to 2000 mg per day

DRUG

linagliptin

5 mg daily

DRUG

metformin placebo

0 to 2 tablets daily

DRUG

metformin placebo

4 tablets 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
2012-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Canada
  • India
  • Israel
  • Malaysia
  • Mexico
  • Philippines
  • Puerto Rico
  • Russia
  • Sri Lanka
  • Thailand
  • 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 NCT01512979 on ClinicalTrials.gov