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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00146289
First received: September 2, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Obesity
Insulin Resistance
Drug: MICARDIS® (telmisartan)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 138
Study Start Date: February 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146289

Locations
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
Denmark
Århus Sygehus
Aarhus C, Denmark
Germany
Universitätsmedizin Berlin
Berlin, Germany
Boehringer Ingelheim Investigational Site
Künzing, Germany
Boehringer Ingelheim Investigational Site
Unterschneidheim, Germany
Italy
Policlinico Monteluce
Perugia, Italy
Azienda Ospedale Università di Pisa
Pisa, Italy
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00146289     History of Changes
Other Study ID Numbers: 502.469
Study First Received: September 2, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Insulin Resistance
Overweight
Body Weight
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Signs and Symptoms
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014