Japanese P III vs Voglibose and Placebo

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00654381
First received: April 3, 2008
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 1356
Drug: voglibose placebo
Drug: BI 1356 placebo
Drug: voglibose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in HbA1c at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  • Change From Baseline in HbA1c at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  • Examination of Long-term Safety of Linagliptin (52-week Treatment) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Relative Efficacy Response of HbA1c at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12

  • Relative Efficacy Response of HbA1c at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26

  • Relative Efficacy Response of HbA1c at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication


Enrollment: 561
Study Start Date: April 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: BI 1356 high dose
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654381

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

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00654381     History of Changes
Other Study ID Numbers: 1218.23
Study First Received: April 3, 2008
Results First Received: May 18, 2011
Last Updated: December 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Voglibose
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014