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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146289
• Other study ID #: 502.469
• Status: Completed
• Phase: Phase 2
• First received: September 2, 2005
• Last updated: October 31, 2013
• Start date: February 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Intervention

Drug:
• MICARDIS® (telmisartan)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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