The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-Diabetic, Normotensive Subjects
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity; Insulin Resistance
Intervention: MICARDIS® (telmisartan) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Summary
The primary objective of this study is to determine whether MICARDIS® improves insulin
sensitivity in overweight or obese, non-diabetic, normotensive subjects.
Clinical Details
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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 AUCglucose ÷ by AUCinsulin; lipids; & inflam markers
Eligibility
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, glucocorticords, 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:
1. SGPT (ALT) or SGOT (AST) >2. 5 times the upper limit of normal range, or
2. Serum creatinine >2. 3 mg/dL (or >203 ?mol/L).
10. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent)
who:
1. have a positive urine pregnancy test (UPT) prior to randomisation (Visit 2 or
Visit 2. 1 for subject participating in the clamp procedure)
2. are not surgically sterile, or
3. are nursing, or pregnant, or
4. 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
Locations and Contacts
Århus Sygehus, Aarhus C, Denmark
Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany
Boehringer Ingelheim Investigational Site, Künzing, Germany
Universitätsmedizin Berlin, Berlin, 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
Additional Information
Starting date: February 2005
Ending date: May 2006
Last updated: April 4, 2008
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