Comprehensive Add on Study in Japan

February 27, 2014 updated by: Boehringer Ingelheim

An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

574

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akishima, Tokyo, Japan
        • 1218.78.008 Boehringer Ingelheim Investigational Site
      • Amagasaki, Hyogo, Japan
        • 1218.78.030 Boehringer Ingelheim Investigational Site
      • Annaka, Gunma, Japan
        • 1218.78.017 Boehringer Ingelheim Investigational Site
      • Aomori, Aomori, Japan
        • 1218.78.006 Boehringer Ingelheim Investigational Site
      • Aomori, Aomori, Japan
        • 1218.78.007 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1218.78.009 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Tokyo, Japan
        • 1218.78.013 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 1218.78.032 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japan
        • 1218.78.040 Boehringer Ingelheim Investigational Site
      • Higashi Osaka, Osaka, Japan
        • 1218.78.037 Boehringer Ingelheim Investigational Site
      • Hitachinaka, Ibaraki, Japan
        • 1218.78.043 Boehringer Ingelheim Investigational Site
      • Isesaki, Gunma, Japan
        • 1218.78.019 Boehringer Ingelheim Investigational Site
      • Kashiwara, Osaka, Japan
        • 1218.78.036 Boehringer Ingelheim Investigational Site
      • Kasugai, Aichi, Japan
        • 1218.78.026 Boehringer Ingelheim Investigational Site
      • Kawachinagano, Osaka, Japan
        • 1218.78.038 Boehringer Ingelheim Investigational Site
      • Kitaazumi-gun, Nagano, Japan
        • 1218.78.021 Boehringer Ingelheim Investigational Site
      • Matsumoto, Nagano, Japan
        • 1218.78.022 Boehringer Ingelheim Investigational Site
      • Matsumoto, Nagano, Japan
        • 1218.78.033 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 1218.78.012 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 1218.78.041 Boehringer Ingelheim Investigational Site
      • Morioka, Iwate, Japan
        • 1218.78.034 Boehringer Ingelheim Investigational Site
      • Morioka, Iwate, Japan
        • 1218.78.035 Boehringer Ingelheim Investigational Site
      • Moriya, Ibaraki, Japan
        • 1218.78.018 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.78.024 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.78.025 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.78.027 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.78.028 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.78.031 Boehringer Ingelheim Investigational Site
      • Oita, Oita, Japan
        • 1218.78.039 Boehringer Ingelheim Investigational Site
      • Okinawa, Okinawa, Japan
        • 1218.78.004 Boehringer Ingelheim Investigational Site
      • Sagae, Yamagata, Japan
        • 1218.78.016 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.78.001 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.78.020 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.78.042 Boehringer Ingelheim Investigational Site
      • Shimajiri-gun, Okinawa, Japan
        • 1218.78.005 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1218.78.014 Boehringer Ingelheim Investigational Site
      • Shinjyuku-ku. Tokyo, Japan
        • 1218.78.002 Boehringer Ingelheim Investigational Site
      • Shizuoka, Shizuoka, Japan
        • 1218.78.011 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1218.78.003 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama, Japan
        • 1218.78.023 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama, Japan
        • 1218.78.029 Boehringer Ingelheim Investigational Site
      • Tsuchiura, Ibaraki, Japan
        • 1218.78.010 Boehringer Ingelheim Investigational Site
      • Yamagata, Yamagata, Japan
        • 1218.78.015 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus
  2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

  1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
  2. Impaired hepatic function
  3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
  4. Treatment with anti-obesity drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bigu+Lina
biguanide plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: Glin+Lina
glinide plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: Glit+Lina
glitazone plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: SU+Lina
sulfonylurea plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Experimental: A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
Drug: Linagliptin
Linagliptin once daily
Active Comparator: SU+Met
sulfonylurea plus metformin
Drug: Metformin
Metformin twice or three time per day
Active Comparator: A-GI+Met
alpha-glucosidase inhibitor plus metformin
Drug: Metformin
Metformin twice or three time per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: The first drug administration through 7 days after the last drug administration, up to 382 days
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
The first drug administration through 7 days after the last drug administration, up to 382 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Haemoglobin A1c (HbA1c)
Time Frame: Baseline and 52 weeks
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.78

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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