Clinical trial NCT00677391: Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-05-14
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.
* 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

Primary outcomes:
measure: Change in bodyweight from baseline to final evaluation
timeFrame: Wk 0, then, bi-weekly through duration of study
Secondary outcomes:
measure: The percentage of change in body weight from baseline to final evaluation.
timeFrame: Wk 0 and Wk 24
measure: Total body fat mass, total body lean mass, percent of total body lean mass measurements (Bodystat® 1500)
timeFrame: Wks 0, 12 and 24
measure: Total Abdominal Fat Mass, Total Abdominal Lean Mass, Percent of Total Abdominal Fat Mass and Percent of Total Abdominal Lean Mass (DEXA Scan)
timeFrame: Wk 0 and Wk 24
measure: metabolic measurements (Cholesterol, Triglycerides & Insulin resistance) and SF 36 Quality of life measurement
timeFrame: Wk 0, 12 and Wk 24. In addition to the stated time frames, a Quality of life survey was conducted 30 days post study.
Other outcomes:
Locations:
Study officials:
References: