Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00677391
Recruitment Status : Completed
First Posted : May 14, 2008
Last Update Posted : May 14, 2008
Information provided by:

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
Obesity Drug: Sibutramine Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2002
Actual Primary Completion Date : November 2004

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:
  • ABT-991
  • Meridia
  • Reductil
Placebo Comparator: 2 Drug: Placebo
Capsules, once daily

Primary Outcome Measures :
  1. Change in bodyweight from baseline to final evaluation [ Time Frame: Wk 0, then, bi-weekly through duration of study ]

Secondary Outcome Measures :
  1. The percentage of change in body weight from baseline to final evaluation. [ Time Frame: Wk 0 and Wk 24 ]
  2. Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500) [ Time Frame: Wks 0, 12 and 24 ]
  3. 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 ]
  4. 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. ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Responsible Party: Peter Bacher, Global Project Head, Abbott Identifier: NCT00677391     History of Changes
Other Study ID Numbers: MLAY-02-001
First Posted: May 14, 2008    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008

Keywords provided by Abbott:

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents