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Comprehensive Add on Study in Japan

NCT01204294 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2014-03-28

Study results available
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Summary

The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Linagliptin

Linagliptin once daily

DRUG

Linagliptin

Linagliptin once daily

DRUG

Metformin

Metformin twice or three time per day

DRUG

Metformin

Metformin twice or three time per day

DRUG

Linagliptin

Linagliptin once daily

DRUG

Linagliptin

Linagliptin once daily

DRUG

Linagliptin

Linagliptin once daily

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Japan

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 NCT01204294 on ClinicalTrials.gov