A randomised, double-blind, placebo-controlled, parallel group, 16-week MICARDIS® (160 mg) tablets, proof-of-concept study, evaluating insulin sensitivity in overweight or obese, non-diabetic, normotensives, using the oral glucose tolerance test, with a clamp sub-group. - MICARDIS® 160 mg, proof-of-concept in insuline sensitivity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003986-34-DK

Enrollment

120

Registered

2005-01-13

Start date

2005-03-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight or obese, non-diabetic, normotensive subjects MedDRA version: 7.1 Level: PT Classification code 10052066

Interventions

Trade Name: Micardis Product Name: telmisartan Product Code: BIBR 277 SE Pharmaceutical Form: Tablet INN or Proposed INN: telmisartan Current Sponsor code: BIBR 277 SE Other descriptive name: 4'-[(1,4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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. HbA1C assessed =6.5%. Triglycerides =150, and =500 mg/dL. Fasting Glucose =126 mg/dL. Blood pressure =110/64 and =140/90 mmHg. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion 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, 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. 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. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to determine whether MICARDIS® (telmisartan 160 mg) improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects;Secondary Objective: To assess the lipid profile evolution along the treatment period;Primary end point(s): 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

Time frame

Main Objective: The objective of this study is to determine whether MICARDIS® (telmisartan 160 mg) improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects;Secondary Objective: To assess the lipid profile evolution along the treatment period;Primary end point(s): 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).

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Countries

Denmark, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026