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

NCT00146289 | Completed Phase 2

• 1 other identifier: 502.469
• Study Type: interventional
• Target: 138
• Locations: 5 countries
• Sites: 17

Brief Summary

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

Conditions

Obesity; Insulin Resistance

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

MICARDIS® (telmisartan) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
• Subjects 18-65 years old.
• Body Mass Index (BMI) \>= 28.
• Sedentary life style defined as: Does not engage in vigorous activity for more than 30 minutes per day, more than two times per week.
• Waist circumference \>= 40 inches (102 cm) in men and \>= 35 inches (89 cm) women.
• HbA1C assessed \<= 6.5%.
• Triglycerides \>= 150, and \<= 500 mg/dL.
• Fasting Glucose \<= 126 mg/dL.
• Blood pressure \>= 110/64 and \<= 140/90 mmHg.

You may not qualify if:

• 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.
• 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.
• Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
• Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
• Unstable angina or myocardial infarction or cardiac surgery within the past 3 months.
• PCI (percutaneous coronary intervention) within the past 3 months.
• Stroke within the past 6 months.
• Bilateral renal artery stenosis or obstructive disorders, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
• 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)
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (17)

UCLA School of Medicine- Divison of Endocrinology

Los Angeles, California, United States

Location

University of CA at SanDiego- Department of Endocrinology

San Diego, California, United States

Location

Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

University of Rochester Medical Center

Rochester, New York, United States

Location

Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

Boehringer Ingelheim Investigational Site

Harker Heights, Texas, United States

Location

University of Manitoba, Diabetes Research Group

Winnipeg, Manitoba, Canada

Location

St. Joseph's Health Care London

London, Ontario, Canada

Location

The Ottawa Hospital - Riverside Campus

Ottawa, Ontario, Canada

Location

Århus Sygehus

Aarhus C, Denmark

Location

Universitätsmedizin Berlin

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site

Künzing, Germany

Location

Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

Location

Policlinico Monteluce

Perugia, Italy

Location

Azienda Ospedale Università di Pisa

Pisa, Italy

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: February 1, 2005
• Primary Completion: October 1, 2005
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (8); IT (2); CA (3); DK (1); DE (3)