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Japanese P III vs Voglibose and Placebo
This study is ongoing, but not recruiting participants.
First Received: April 3, 2008   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00654381
  Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of 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
Drug: placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes
Drug Information available for: Voglibose
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change in HbA1c from baseline is determined to compare the efficacy of BI 1356 administered for 12 weeks to placebo and for 26 weeks to voglibose. [ Time Frame: 12 weeks (vs placebo), 26 weeks (vs voglibose), and ]

Secondary Outcome Measures:
  • Relative efficacy response of HbA1c, etc. [ Time Frame: 12 weeks and 26 weeks ]

Estimated Enrollment: 441
Study Start Date: April 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654381

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

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1218.23
Study First Received: April 3, 2008
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00654381     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare;   United States: Food and Drug Administration

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Voglibose
Diabetes Mellitus
 Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Voglibose
 Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 09, 2009



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