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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICARDIS® (telmisartan) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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:
Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
Hematocrit < 35%.
Primary aldosteronism.
Hereditary fructose intolerance.
History of drug or alcohol dependency within the previous 6 months.
Currently participating in a weight loss program.
Any investigational drug therapy within one month of randomisation or during the study.
Known hypersensitivity to any component of the study drug (telmisartan or placebo).
Any circumstances the Investigator feels participation in the study would hinder subject safety or completion of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine- Divison of Endocrinology | Los Angeles | California | United States | |||
| University of CA at SanDiego- Department of Endocrinology |
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| San Diego |
| California |
| United States |
| Boehringer Ingelheim Investigational Site | Westlake Village | California | United States |
| Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| University of Rochester Medical Center | Rochester | New York | United States |
| Boehringer Ingelheim Investigational Site | Cincinnati | Ohio | United States |
| Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| Boehringer Ingelheim Investigational Site | Harker Heights | Texas | United States |
| University of Manitoba, Diabetes Research Group | Winnipeg | Manitoba | Canada |
| St. Joseph's Health Care London | London | Ontario | Canada |
| The Ottawa Hospital - Riverside Campus | Ottawa | Ontario | Canada |
| Århus 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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