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The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00146289
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : November 1, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.

Condition or disease Intervention/treatment Phase
Obesity Insulin Resistance Drug: MICARDIS® (telmisartan) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomised, DB, Placebo-controlled, Parallel Group, 16-wk MICARDIS (160mg) Tab, Proof-of-concept, Evaluating Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive, Using the OGTT, With a Clamp Sub-group
Study Start Date : February 2005
Actual Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Telmisartan

Primary Outcome Measures :
  1. The primary endpoint is the change from baseline to the end of study (16 weeks) in the insulin sensitivity index as estimated by the composite index (R04-1184) calculated from a 3-hour oral glucose tolerance test (OGTT).

Secondary Outcome Measures :
  1. From baseline: Glucose disposal rates; Insulin sensitivity (IS) index as Rd/I (clamp); IS index (OGTT- min model); Insulin secretion capacity; fasting insulin & gluc.; AUC gluc & insulin; ratio of AUC glucose ÷ by AUC insulin; lipids & inflam. markers.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
  2. Subjects 18-65 years old.
  3. Body Mass Index (BMI) >= 28.
  4. Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
  5. Waist circumference >= 40 inches (102 cm) in men and >= 35 inches (89 cm) women.
  6. HbA1C assessed <= 6.5%.
  7. Triglycerides >= 150, and <= 500 mg/dL.
  8. Fasting Glucose <= 126 mg/dL.
  9. Blood pressure >= 110/64 and <= 140/90 mmHg.

Exclusion Criteria:

  1. Currently taking any antihypertensive medications (e.g., thiazide or loop diuretics), diabetic medications, medications known to alter insulin sensitivity (e.g., statins), steroids, glucocorticoids, niacin, nicotinic acid, and anti-psychotic/depressant drugs (e.g., prozocin). Including over the counter (OTC) and herbal products, which are known to affect metabolic function.
  2. Diagnosis of any of the following chronic diseases: hypertension, diabetes mellitus, renal insufficiency, congestive heart failure, hepatic insufficiency, biliary obstructive disorders, autoimmune disease, HIV, coronary artery disease, mental illness, and severe anemia.
  3. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
  4. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
  5. Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
  6. PCI (percutaneous coronary intervention) within the past 3 months.
  7. Stroke within the past 6 months.
  8. Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
  9. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • SGPT (ALT) or SGOT (AST) > 2.5 times the upper limit of normal range, or
    • Serum creatinine > 2.3 mg/dL (or > 203 mol/L)
  10. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

    • Have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or Visit 2.1 for subject participating in the clamp procedure)
    • Are not surgically sterile, or
    • Are nursing, or pregnant, or
    • Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study and do not agree to periodic pregnancy testing during participation in the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable or injectable contraceptives and estrogen patch. No exceptions will be made.
  11. Hematocrit < 35%.
  12. Primary aldosteronism.
  13. Hereditary fructose intolerance.
  14. History of drug or alcohol dependency within the previous 6 months.
  15. Currently participating in a weight loss program.
  16. Any investigational drug therapy within one month of randomisation or during the study.
  17. Known hypersensitivity to any component of the study drug (telmisartan or placebo).
  18. Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146289

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United States, California
UCLA School of Medicine- Divison of Endocrinology
Los Angeles, California, United States
University of CA at SanDiego- Department of Endocrinology
San Diego, California, United States
Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
United States, Illinois
Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, New York
University of Rochester Medical Center
Rochester, New York, United States
United States, Ohio
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Tennessee
Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Texas
Boehringer Ingelheim Investigational Site
Harker Heights, Texas, United States
Canada, Manitoba
University of Manitoba, Diabetes Research Group
Winnipeg, Manitoba, Canada
Canada, Ontario
St. Joseph's Health Care London
London, Ontario, Canada
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario, Canada
Århus Sygehus
Aarhus C, Denmark
Universitätsmedizin Berlin
Berlin, Germany
Boehringer Ingelheim Investigational Site
Künzing, Germany
Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany
Policlinico Monteluce
Perugia, Italy
Azienda Ospedale Università di Pisa
Pisa, Italy
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
Additional Information:
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ClinicalTrials.gov Identifier: NCT00146289    
Other Study ID Numbers: 502.469
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013
Additional relevant MeSH terms:
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Insulin Resistance
Body Weight
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action