Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population
Study Details
Study Description
Brief Summary
The primary objective of this study was to evaluate the efficacy and the safety of sibutramine vs. placebo in combination with a hypocaloric diet on weight-loss in overweight and obese Malaysian subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Drug: Sibutramine
Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
Other Names:
|
| Placebo Comparator: 2
|
Drug: Placebo
Capsules, once daily
|
Outcome Measures
Primary Outcome Measures
- Change in bodyweight from baseline to final evaluation [Wk 0, then, bi-weekly through duration of study]
Secondary Outcome Measures
- The percentage of change in body weight from baseline to final evaluation. [Wk 0 and Wk 24]
- Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500) [Wks 0, 12 and 24]
- Total Abdominal Fat Mass, Total Abdominal Lean Mass, Percent of Total Abdominal Fat Mass and Percent of Total Abdominal Lean Mass (DEXA Scan) [Wk 0 and Wk 24]
- metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement [Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The subject did not adequately respond (i.e., did not achieve or maintain > 5%weight loss) to an appropriate non-pharmacologic weight-reducing regimen (i.e., diet and exercise) within 3 months prior to Screening.
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The subject was male or female and between 18 and 65 years of age.
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The subject has nutritional obesity and BMI >= 27 kg/m2 associated with dyslipidemia or has BMI >= 30 kg/m2.
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Dyslipidemia was defined as having at least one of the following three conditions:
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Low-density lipoprotein (LDL)-cholesterol level of > 3.4 mmol/L (> 130 mg/dL)
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total cholesterol level of > 5.2 mmol/L (> 200 mg/dL)
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triglyceride level of > 1.7 mmol/L (> 150 mg/dL). 254
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If the subject was female
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she must either not of childbearing potential: defined as postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
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or was of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)on contraceptives (oral or parenteral) for the 3-month period prior to Week 0, a vasectomized partner, total abstinence from sexual intercourse
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If the subject was female, the results of a urine pregnancy test performed at Screening and Week 0 were negative.
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If the subject was female, the subject was not breast-feeding.
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The subject was judged to be in general good health based upon the results of medical history, complete physical examination and clinical laboratory tests.
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The subject was not taking any over-the-counter or prescription drugs, or herbal products for weight loss during the 4 week period prior to Screening.
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The subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to undertaking any study-specific procedures
Exclusion Criteria:
-
History or evidence according to the 1997 American Diabetic Association (ADA)26criteria of type 1 or type 2 diabetes mellitus, i.e., fasting plasma glucose level >= 7.0 mmol/L.
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Inadequately controlled hypertension having systolic blood pressure >= 145 mmHg or diastolic blood pressure >= 90 mmHg (average of three measurements) or any hypertensive subjects taking > 3 medications to control blood pressure.
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History of Gilles de la Tourette's Syndrome.
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Use within 4 weeks prior to Week 0 of any of the following:
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Monoamine oxidase inhibitors (MAOIs): used to treat depression and Parkinson's disease.
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Medications that regulate the neurotransmitter serotonin in the brain (SSRIs): used to treat psychiatric disorders and to stop smoking.
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Amino acids: used to treat sleep disorders.
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Certain antimigraine drugs (such as sumatriptan, dihydroergotamine).
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Opioids (such as pentazocine, pethidine, fentanyl, dextromethorphan).
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Organic causes of obesity (e.g., hypothyroidism).
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History of major eating disorders, such as anorexia nervosa or bulimia nervosa.
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History of benign prostatic hyperplasia with urinary retention.
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History of neurological disorders such as seizures.
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History of documented psychiatric illnesses such as anxiety, depression, bipolar disorder or schizophrenia or having psychotic symptoms.
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History or evidence of severe renal or hepatic impairments.
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History of narrow-angle glaucoma.
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History of coronary artery disease, congestive heart failure, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (transient ischemic attacks or strokes).13. History or evidence of hyperthyroidism.
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Persistent tachycardia at rest, i.e., heart rate >100 bpm (average of 3 measurements).
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History of primary or secondary pulmonary hypertension.
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Underlying or suspected phaeochromocytoma.
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Known hypersensitivity to sibutramine hydrochloride monohydrate or any other component of the product.
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Known history of drug or alcohol abuse.
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Has previous history with the use of sibutramine.
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Any other medical illnesses judged by the investigator that may compromise the efficacy or safety of sibutramine.
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Unlikely to cooperate in the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Abbott
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MLAY-02-001