Official Title: “Randomized Trial of Obese Non-Diabetic Malaysians Using Sibutramine: A Randomized Double-Blind Placebo-Controlled Study of Sibutramine in the Management of Obese Subjects in Malaysia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment

Study Primary Completion Date: November 2004

Intervention(s) in this Clinical Trial

• Drug: Sibutramine
  • Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.
• Drug: Placebo
  • Capsules, once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Change in bodyweight from baseline to final evaluation
  • Time Frame: Wk 0, then, bi-weekly through duration of study
    Safety Issue?: No

Secondary Measures

• The percentage of change in body weight from baseline to final evaluation.
  • Time Frame: Wk 0 and Wk 24
    Safety Issue?: No
• Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500)
  • Time Frame: Wks 0, 12 and 24
    Safety Issue?: No
• Total Abdominal Fat Mass, Total Abdominal Lean Mass, Percent of Total Abdominal Fat Mass and Percent of Total Abdominal Lean Mass (DEXA Scan)
  • Time Frame: Wk 0 and Wk 24
    Safety Issue?: No
• metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement
  • Time Frame: Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study.
    Safety Issue?: No

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.
• The subject was male or female and between 18 and 65 years of age.
• The subject has nutritional obesity and BMI >= 27 kg/m2 associated with dyslipidemia or has BMI >= 30 kg/m2.
• Dyslipidemia was defined as having at least one of the following three conditions:
• Low-density lipoprotein (LDL)-cholesterol level of > 3.4 mmol/L (> 130 mg/dL)
• total cholesterol level of > 5.2 mmol/L (> 200 mg/dL)
• triglyceride level of > 1.7 mmol/L (> 150 mg/dL). 254
• If the subject was female
• 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),
• 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
• If the subject was female, the results of a urine pregnancy test performed at
• Screening and Week 0 were negative.
• If the subject was female, the subject was not breast-feeding.
• The subject was judged to be in general good health based upon the results of medical history, complete physical examination and clinical laboratory tests.
• 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.
• 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.
• 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.
• History of Gilles de la Tourette's Syndrome.
• Use within 4 weeks prior to Week 0 of any of the following:
• Monoamine oxidase inhibitors (MAOIs): used to treat depression and Parkinson's disease.
• Medications that regulate the neurotransmitter serotonin in the brain (SSRIs): used to treat psychiatric disorders and to stop smoking.
• Amino acids: used to treat sleep disorders.
• Certain antimigraine drugs (such as sumatriptan, dihydroergotamine).
• Opioids (such as pentazocine, pethidine, fentanyl, dextromethorphan).
• Organic causes of obesity (e.g., hypothyroidism).
• History of major eating disorders, such as anorexia nervosa or bulimia nervosa.
• History of benign prostatic hyperplasia with urinary retention.
• History of neurological disorders such as seizures.
• History of documented psychiatric illnesses such as anxiety, depression, bipolar disorder or schizophrenia or having psychotic symptoms.
• History or evidence of severe renal or hepatic impairments.
• History of narrow-angle glaucoma.
• 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.
• Persistent tachycardia at rest, i.e., heart rate >100 bpm (average of 3 measurements).
• History of primary or secondary pulmonary hypertension.
• Underlying or suspected phaeochromocytoma.
• Known hypersensitivity to sibutramine hydrochloride monohydrate or any other component of the product.
• Known history of drug or alcohol abuse.
• Has previous history with the use of sibutramine.
• Any other medical illnesses judged by the investigator that may compromise the efficacy or safety of sibutramine.
• Unlikely to cooperate in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00677391

Study ID Number: MLAY-02-001

ClinicalTrials.gov Identifier: NCT00677391

Health Authority: Malaysia: Ministry of Health

Protocol No. MLAY-02-001. Randomized Trial of Obese Non-Diabetic Malaysians using Sibutramine: A Randomized Double-Blind Placebo-Controlled Study of ...(