ObesityPhase 2NCT00146289
The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
A Phase 2 study testing MICARDIS® (telmisartan) in people with Obesity and Insulin Resistance, run by Boehringer Ingelheim at 17 sites in 5 countries.
Trial summary
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance
- What is being tested?
- MICARDIS® (telmisartan)
- How many people
- 138 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Feb 2005to Oct 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- Triglycerides >= 150, and <= 500 mg/dL.
- Fasting Glucose <= 126 mg/dL.
- Blood pressure >= 110/64 and <= 140/90 mmHg.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
United States8 sites
Boehringer Ingelheim Investigational Site
Chicago, Illinois
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
Boehringer Ingelheim Investigational Site
Harker Heights, Texas
UCLA School of Medicine- Divison of Endocrinology
Los Angeles, California
Boehringer Ingelheim Investigational Site
Nashville, Tennessee
University of Rochester Medical Center
Rochester, New York
University of CA at SanDiego- Department of Endocrinology
San Diego, California
Boehringer Ingelheim Investigational Site
Westlake Village, California
Canada3 sites
St. Joseph's Health Care London
London, Ontario
The Ottawa Hospital - Riverside Campus
Ottawa, Ontario
University of Manitoba, Diabetes Research Group
Winnipeg, Manitoba
Germany3 sites
Universitätsmedizin Berlin
Berlin
Boehringer Ingelheim Investigational Site
Künzing
Boehringer Ingelheim Investigational Site
Unterschneidheim
Italy2 sites
Policlinico Monteluce
Perugia
Azienda Ospedale Università di Pisa
Pisa
About this study
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
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
- Being tested
- MICARDIS® (telmisartan)
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICARDIS® (telmisartan)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 138 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146289
- Sponsor's protocol ID
- 502.469
- Status last verified
- Oct 2013
- First submitted
- 2 Sep 2005
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00146289
- Acronym / sponsor ID
- 502.469
- Conditions
- Obesity, Insulin Resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Oct 2005 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether MICARDIS® improves insulin sensitivity in overweight or obese, non-diabetic, normotensive subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICARDIS® (telmisartan) | Drug | – |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MICARDIS® (telmisartan) in people with Obesity and Insulin Resistance, run by Boehringer Ingelheim at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Germany, Italy, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.