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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Drug: Sibutramine; Drug: Placebo

• Registration Number: NCT00677391
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-11
• Status Verified: 2008-05
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-13
• Last Update Submitted: 2008-05-13
• Study First Posted: 2008-05-14
• Last Update Posted: 2008-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sibutramine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in bodyweight from baseline to final evaluation	Wk 0, then, bi-weekly through duration of study

Secondary Outcome Measures

Name	Time	Method
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.