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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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00146289
Collaborator
(none)
138
Enrollment
17
Locations
8.1
Patients Per Site

Study Details

Study Description

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
  • Drug: MICARDIS® (telmisartan)
 Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2005
Actual Primary Completion Date :
Oct 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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)

  1. 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.

  1. Hematocrit < 35%.

  2. Primary aldosteronism.

  3. Hereditary fructose intolerance.

  4. History of drug or alcohol dependency within the previous 6 months.

  5. Currently participating in a weight loss program.

  6. Any investigational drug therapy within one month of randomisation or during the study.

  7. Known hypersensitivity to any component of the study drug (telmisartan or placebo).

  8. Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA School of Medicine- Divison of Endocrinology Los Angeles California United States
2 University of CA at SanDiego- Department of Endocrinology San Diego California United States
3 Boehringer Ingelheim Investigational Site Westlake Village California United States
4 Boehringer Ingelheim Investigational Site Chicago Illinois United States
5 University of Rochester Medical Center Rochester New York United States
6 Boehringer Ingelheim Investigational Site Cincinnati Ohio United States
7 Boehringer Ingelheim Investigational Site Nashville Tennessee United States
8 Boehringer Ingelheim Investigational Site Harker Heights Texas United States
9 University of Manitoba, Diabetes Research Group Winnipeg Manitoba Canada
10 St. Joseph's Health Care London London Ontario Canada
11 The Ottawa Hospital - Riverside Campus Ottawa Ontario Canada
12 Århus Sygehus Aarhus C Denmark
13 Universitätsmedizin Berlin Berlin Germany
14 Boehringer Ingelheim Investigational Site Künzing Germany
15 Boehringer Ingelheim Investigational Site Unterschneidheim Germany
16 Policlinico Monteluce Perugia Italy
17 Azienda Ospedale Università di Pisa Pisa Italy

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00146289
Other Study ID Numbers:
  • 502.469
First Posted:
Sep 7, 2005
Last Update Posted:
Nov 1, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Insulin Resistance
Overweight
Telmisartan

Study Results

No Results Posted as of Nov 1, 2013