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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

Primary Purpose

Obesity, Insulin Resistance

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MICARDIS® (telmisartan)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. 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. 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: 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 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. 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.

Sites / Locations

  • UCLA School of Medicine- Divison of Endocrinology
  • University of CA at SanDiego- Department of Endocrinology
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University of Rochester Medical Center
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • University of Manitoba, Diabetes Research Group
  • St. Joseph's Health Care London
  • The Ottawa Hospital - Riverside Campus
  • Århus Sygehus
  • Universitätsmedizin Berlin
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Policlinico Monteluce
  • Azienda Ospedale Università di Pisa

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 2, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00146289
Brief Title
The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
138 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MICARDIS® (telmisartan)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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. 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: 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 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA School of Medicine- Divison of Endocrinology
City
Los Angeles
State/Province
California
Country
United States
Facility Name
University of CA at SanDiego- Department of Endocrinology
City
San Diego
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Harker Heights
State/Province
Texas
Country
United States
Facility Name
University of Manitoba, Diabetes Research Group
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
St. Joseph's Health Care London
City
London
State/Province
Ontario
Country
Canada
Facility Name
The Ottawa Hospital - Riverside Campus
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Århus Sygehus
City
Aarhus C
Country
Denmark
Facility Name
Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Künzing
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Unterschneidheim
Country
Germany
Facility Name
Policlinico Monteluce
City
Perugia
Country
Italy
Facility Name
Azienda Ospedale Università di Pisa
City
Pisa
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.469_U06-3205.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/502/502.469_literature.pdf
Description
Related Info

Learn more about this trial

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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