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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: MICARDIS® (telmisartan)

Primary 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 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.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00146289

Study ID Number: 502.469

ClinicalTrials.gov Identifier: NCT00146289

Health Authority: United States: Food and Drug Administration