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

Condition(s) targeted: Obesity; Insulin Resistance

Intervention: MICARDIS® (telmisartan) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim

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

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Ã…rhus 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

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

Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States

University of Manitoba, Diabetes Research Group, Winnipeg, Manitoba, Canada

University of Rochester Medical Center, Rochester, New York, United States

Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States

St. Joseph's Health Care London, London, Ontario, Canada

The Ottawa Hospital - Riverside Campus, Ottawa, Ontario, Canada

Boehringer Ingelheim Investigational Site, Nashville, Tennessee, United States

Boehringer Ingelheim Investigational Site, Harker Heights, Texas, United States

Starting date: February 2005
Last updated: October 31, 2013