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4 Weeks Treatment With BI 10773 in Japanese Type 2 Diabetic Patients
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, August 2009
First Received: April 20, 2009   Last Updated: August 20, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00885118
  Purpose

The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Randomised, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Urine glucose excretion Plasma glucose [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • HbA1c Fructosamine 1.5 anhydroglucitol [ Time Frame: 28 days ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
  2. HbA1c at screening (Visit 1)

    • For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
    • For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
  3. Age betwen 20 and 70 years
  4. Body mass index (BMI) between18.0 and 40.0 kg/m2
  5. Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.

Exclusion Criteria:

  1. Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
  2. Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
  3. Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
  4. Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as

    • Renal insufficiency (calculated estimated glomerular filtration rate <60)
    • Cardiac insufficiency of NYHA II-IV or other known cardiovascular diseases including hypertension of >160/95 mmHg,
    • Neurological disorders (such as epilepsy) or psychiatric disorders
    • Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
    • Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
  5. Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:

    • Statins.
    • Antihypertensives (diuretics not allowed)
    • Beta-Blockers for BPH.
    • Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885118

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Japan
1245.15.001 Boehringer Ingelheim Investigational Site Recruiting
Nakano-ku, Tokyo, Japan
1245.15.002 Boehringer Ingelheim Investigational Site Recruiting
Koganei, Tokyo, Japan
1245.15.003 Boehringer Ingelheim Investigational Site Recruiting
Hachioji, Tokyo, Japan
1245.15.004 Boehringer Ingelheim Investigational Site Recruiting
Yokohama, Kanagawa, Japan
1245.15.005 Boehringer Ingelheim Investigational Site Recruiting
Suita, Osaka, 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: 1245.15
Study First Received: April 20, 2009
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00885118     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:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 24, 2009