Japanese P III vs Voglibose and Placebo

December 11, 2013 updated by: Boehringer Ingelheim

A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety

The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

561

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
      • Asahi, Chiba, Japan
        • 1218.23.05 Boehringer Ingelheim Investigational Site
      • Funabashi, Chiba, Japan
        • 1218.23.06 Boehringer Ingelheim Investigational Site
      • Hitachinaka, Ibaraki, Japan
        • 1218.23.21 Boehringer Ingelheim Investigational Site
      • Hitachiota, Ibaraki, Japan
        • 1218.23.44 Boehringer Ingelheim Investigational Site
      • Imizu, Toyama, Japan
        • 1218.23.09 Boehringer Ingelheim Investigational Site
      • Inashiki-gun, Ibaraki, Japan
        • 1218.23.45 Boehringer Ingelheim Investigational Site
      • Izumisano, Osaka, Japan
        • 1218.23.13 Boehringer Ingelheim Investigational Site
      • Kariya, Aichi, Japan
        • 1218.23.27 Boehringer Ingelheim Investigational Site
      • Kitakatsushika-gun, Saitama, Japan
        • 1218.23.47 Boehringer Ingelheim Investigational Site
      • Kitakyuushuu, Fukuoka, Japan
        • 1218.23.39 Boehringer Ingelheim Investigational Site
      • Koriyama, Fukushima, Japan
        • 1218.23.02 Boehringer Ingelheim Investigational Site
      • Koriyama, Fukushima, Japan
        • 1218.23.03 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japan
        • 1218.23.10 Boehringer Ingelheim Investigational Site
      • Marugame, Kagawa, Japan
        • 1218.23.37 Boehringer Ingelheim Investigational Site
      • Marugame, Kagawa, Japan
        • 1218.23.38 Boehringer Ingelheim Investigational Site
      • Matsumoto, Nagano, Japan
        • 1218.23.23 Boehringer Ingelheim Investigational Site
      • Meguro-ku, Tokyo, Japan
        • 1218.23.07 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.23.25 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.23.26 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.23.28 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.23.29 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japan
        • 1218.23.30 Boehringer Ingelheim Investigational Site
      • Naka, Ibaraki, Japan
        • 1218.23.04 Boehringer Ingelheim Investigational Site
      • Nishi-ku, Hiroshima, Hiroshima, Japan
        • 1218.23.15 Boehringer Ingelheim Investigational Site
      • Nishi-ku, Sakai, Osaka, Japan
        • 1218.23.34 Boehringer Ingelheim Investigational Site
      • Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
        • 1218.23.22 Boehringer Ingelheim Investigational Site
      • Oita, Oita, Japan
        • 1218.23.16 Boehringer Ingelheim Investigational Site
      • Oita, Oita, Japan
        • 1218.23.40 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama, Japan
        • 1218.23.36 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.23.11 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.23.12 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.23.32 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.23.33 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japan
        • 1218.23.35 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.17 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.18 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.19 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.41 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.42 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japan
        • 1218.23.43 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 1218.23.01 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japan
        • 1218.23.20 Boehringer Ingelheim Investigational Site
      • Shinjuku-ku, Tokyo, Japan
        • 1218.23.46 Boehringer Ingelheim Investigational Site
      • Shinjyuku-ku,Tokyo, Japan
        • 1218.23.08 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japan
        • 1218.23.14 Boehringer Ingelheim Investigational Site
      • Takatsuki, Osaka, Japan
        • 1218.23.31 Boehringer Ingelheim Investigational Site
      • Yokohama, Kanagawa, Japan
        • 1218.23.48 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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
  2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
  3. Age: >= 20 and <= 80
  4. Body Mass Index (BMI) <= 40 kg/m2

Exclusion criteria:

  1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
  2. Impaired hepatic function
  3. History of severe allergy/hypersensitivity
  4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
  5. Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: voglibose 0.2 mg three times a day (TID)
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
Drug: voglibose
0.6 mg/daily
Experimental: BI 1356 low dose
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
Drug: BI 1356
5 mg/daily
Drug: BI 1356
10 mg/daily
Experimental: BI 1356 high dose
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
Drug: BI 1356
5 mg/daily
Drug: BI 1356
10 mg/daily
Placebo Comparator: placebo
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Drug: voglibose placebo
three times daily
Drug: BI 1356 placebo
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c at Week 12
Time Frame: 12 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
12 weeks
Change From Baseline in HbA1c at Week 26
Time Frame: 26 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
26 weeks
Examination of Long-term Safety of Linagliptin (52-week Treatment)
Time Frame: 52 weeks
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative Efficacy Response of HbA1c at Week 12
Time Frame: 12 weeks
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
12 weeks
Relative Efficacy Response of HbA1c at Week 26
Time Frame: 26 weeks
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
26 weeks
Relative Efficacy Response of HbA1c at Week 52
Time Frame: 52 weeks
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Time Frame: 12 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Time Frame: 26 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
26 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Time Frame: 52 weeks
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
52 weeks

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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.

General Publications

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

April 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1218.23

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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