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Efficacy and Safety of 3 Doses of BI1356 in Type 2 Diabetes Patients
This study has been completed.
First Received: May 18, 2006   Last Updated: January 27, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00328172
  Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 1356 BI
Drug: Dose-matched Placebo
Drug: Open-label metformin
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-Label Metformin Treatment Arm)

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Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 302
Study Start Date: May 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
  2. Diagnosis of Type 2 diabetes with duration of at least 3 months
  3. Glycosylated haemoglobin A1 (HbA1c) of:

    7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)

  4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
  5. Age >=21 and <=75 years.
  6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
  7. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria:

  1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or TIA within six months before enrolment)
  2. Impaired hepatic function defined by serum levels of either ALT (SGPT), AST (SGOT) or alkaline phosphatase above 3-fold upper limit of normal
  3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
  5. Chronic or clinically relevant acute infections (e.g., HIV, Hepatitis)
  6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
  7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
  8. Treatment with insulin within 3 months prior to screening
  9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
  12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

    1. are not surgically sterile,
    2. or are nursing or pregnant;
    3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, IUDs, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
  13. Intolerance of metformin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328172

  Show 71 Study Locations
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: 1218.5
Study First Received: May 18, 2006
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00328172     History of Changes
Health Authority: Australia: Responsilble Ethics Committee;   Canada: Health Canada (TPD);   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 11, 2009