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BI 1356 in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00602472
  Purpose

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 1356
Drug: Placebo
Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Metformin Metformin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg) Administered Orally Once Daily Over 24 Weeks, With an Open-Label Extension to One Year (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With a Sulphonylurea

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the last observation prior to the treatment phase. [ Time Frame: After 24 weeks of treatment ]

Secondary Outcome Measures:
  • occurrence of a treat to target response, that is an HbA1c under treatment of < 7.0% after 24 weeks of treatment, occurrence of a treat to target response, that is an HbA1c under treatment of < 6.5% after 24 weeks of treatment [ Time Frame: After 24 weeks of treatment ]

Estimated Enrollment: 800
Study Start Date: February 2008
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 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 mellitus, currently treated only with a stable total daily dose of preferably* >/= 1500 mg metformin and a dose of a sulphonylurea drug that has been documented, by the Investigator, to be the individual maximum tolerated dose of that sulphonylurea drug. Both the dose and dosing regimen of metformin and the sulphonylurea must be stable (i.e. unchanged) for 10 weeks prior to informed consent, and must not be changed for the duration of the trial
  2. Glycosylated haemoglobin A1 (HbA1c) >/= 7.0 and </= 10.0% at the screening Visit 1a and at Visit 2 (start of placebo run-in phase)
  3. Age >/= 18 and </= 80 years at Visit 1a (screening)
  4. BMI (Body Mass Index) </= 40 kg/m2 at Visit 1a (screening)
  5. Signed and dated written informed consent, at the latest by the date of Visit 1a, in accordance with GCP and local legislation *Patients currently treated with a total daily dose of less than 1500 mg metformin can be included in the trial if the Investigator has documented that the dose is the maximum tolerated dose of metformin for that patient.

Exclusion Criteria:

  1. Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
  2. Impaired hepatic function, defined by serum levels of either alanine transaminase, ALT (SGPT), aspartase transaminase, AST (SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
  3. Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
  4. Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
  5. Treatment with GLP-1 analogues (e.g. exanatide) within 3 months prior to the date of informed consent
  6. Treatment with insulin within 3 months prior to the date of informed consent
  7. Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
  8. Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
  9. Pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:

    • are nursing or pregnant
    • 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 periodic pregnancy testing during their participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
  10. Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
  11. Dehydration (as confirmed by the Investigators clinical opinion)
  12. Current acute or chronic metabolic acidosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602472

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

  Show 100 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1218.18, EudraCT Number: 2007-002450-28
Study First Received: January 15, 2008
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00602472  
Health Authority: Argentina: Ministry of Health;   Belgium: Federal Agency for Medicines and Health Products;   Canada: Therapeutic Products Directorate;   China: State Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Korea, Republic of: Korea Food and Drug Administration;   Philippines: Department of Health;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Taiwan: Dept of Health Taiwan;   Turkey: Ministery of Health;   United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on January 14, 2009