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ObesityPhase 3NCT00941382

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

A Phase 3 study testing Sibutramine-Metformin, Sibutramine and Metformin in people with Obesity, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients. Read more about this study

Who is it for?
Ages 30 to 50 years
Conditions the study is for
Obesity
What is being tested?
Sibutramine-Metformin, Sibutramine and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteMexico
Study dates
Nov 2008to Sep 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 30 and 50 years
  • Both genders
  • BMI between 30 and 40
  • Stable body weigh defined by over 5 per cent variability during the previous 3 months
  • Fasting serum glucose less than 126 mg per dl
  • Blood pressure over 140 and 90 mmHg
Show all 9Show fewer
  • Women ensuring contraceptive precautions.
  • Communication and understanding capability.
  • Informed consent awarding.

Who cannot join

  • Women were excluded if they were pregnant or lactating potential while no taking adequate contraceptive precautions
  • Any smoking during the preceding 6 months
  • No physical activity, defined by less than 15 minutes per day of walking
  • Excessive physical activity equivalent to running over 60 minutes per day
  • Known hypersensitivity to sibutramine or metformin
  • Low commitment to follow the protocol statements
Show all 17Show fewer
  • Any investigational medication during the preceding 6 months
  • Any drug or substance mayor toxicity exposure during the preceding 3 months
  • Alcohol or any drug abuse during the previous 3 months
  • Current medication of oral corticosteroids, anticoagulants, sympathomimetics, sympatholytics, lipid lowering drugs, any medication for type 2 diabetes, and any sibutramine interaction drug
  • Current or previous evidence of ischemic heart disease, cardiac arrhythmia, cerebrovascular disease, chronic hepatic disease, two fold persistent elevation of ALT, AST or FA
  • Carrying a pacemaker or any permanent bioelectronic component that could interfere with bioimpedance process
  • Renal failure defined by serum creatinine equal or ever 1.2 mg per dL
  • Not controlled thyroid disease defined by altered serum T3, T4 and TSH during the previous 3 months
  • Hypertension
  • Type 2 diabetes
  • Anti-depressants, or any psychiatric disturbance treatment

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Universitario de Ciencias de la Salud

    Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Official title: Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients

The aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients.

Read the detailed description

The treatment of obesity is strongly recommended because it exacerbates insulin resistance, hypertension, dyslipidemia and atherosclerosis, and represents a risk factor for type 2 diabetes. Although diet and exercise are valuable in this treatment, patient compliance is a major problem. Sibutramine has been shown to be a highly effective pharmacotherapy for weigh loss in obese patients, mediated by increased satiety and an enhancement of energy expenditure. Metformin is widely used for glycemia control and is associated with a small to moderate body weight loss. We are assessing the combination of sibutramine and metformin, two agents with different mechanisms of action for control of body weight and metabolic dysregulation.

Conditions
Obesity
Being tested
Sibutramine-Metformin, Sibutramine, Metformin
Keywords
sibutramine, metformin, obesity
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sibutramine-MetforminDrug

    Also called combination therapy

    sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days

  • SibutramineDrug

    Also called Sibutramine monohidrate Hydrochloride

    15 mg per day for 180 days

  • MetforminDrug

    Also called Metformin Hydrochloride

    Metformin 850 mg per day for 180 days

Study groups in NCT00941382
Study groupRoleWhat they receive
Sibutramin-MetforminExperimentalSibutramine-metformin therapy in a single tablet
Receives: Drug: Sibutramine-Metformin
SibutramineActive comparatorSibutramine monotherapy
Receives: Drug: Sibutramine
MetforminActive comparatorMetformin monotherapy
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein

    Measured: 6 months

Secondary outcomes (2)

  1. improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity

    Measured: 6 months

  2. adverse events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2009 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2009 (estimated)
  4. Study completionSep 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941382
Sponsor's protocol ID
OB Sil-02
Status last verified
Jul 2009
First submitted
14 Jul 2009
Last updated
17 Jul 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Cachofeiro V. Obesidad, Inflamación y disfunción endotelial. Rev Esp Obes 4: 194-204, 2006.

  • Ferrannini E, Mari A. How to measure insulin sensitivity. J Hypertens. 1998 Jul;16(7):895-906. doi: 10.1097/00004872-199816070-00001.

    PubMed 9794728

  • Lyle WG; Plastic Surgery Educational Foundation DATA Committee. Pharmacological treatment of obesity. Plast Reconstr Surg. 2002 Nov;110(6):1577-80. doi: 10.1097/01.PRS.0000028331.84171.86. No abstract available.

    PubMed 12409783

  • Luque CA, Rey JA. The discovery and status of sibutramine as an anti-obesity drug. Eur J Pharmacol. 2002 Apr 12;440(2-3):119-28. doi: 10.1016/s0014-2999(02)01423-1.

    PubMed 12007530

  • Weigle DS. Pharmacological therapy of obesity: past, present, and future. J Clin Endocrinol Metab. 2003 Jun;88(6):2462-9. doi: 10.1210/jc.2003-030151. No abstract available.

    PubMed 12788841

  • Hundal RS, Inzucchi SE. Metformin: new understandings, new uses. Drugs. 2003;63(18):1879-94. doi: 10.2165/00003495-200363180-00001.

    PubMed 12930161

  • Bloomgarden ZT. Metformin. Diabetes Care. 1995 Jul;18(7):1078-80. doi: 10.2337/diacare.18.7.1078. No abstract available.

    PubMed 7555549

  • Campbell I. The obesity epidemic: can we turn the tide? Heart. 2003 May;89 Suppl 2(Suppl 2):ii22-4; discussion ii35-7. doi: 10.1136/heart.89.suppl_2.ii22.

    PubMed 12695431

  • McNulty SJ, Ur E, Williams G; Multicenter Sibutramine Study Group. A randomized trial of sibutramine in the management of obese type 2 diabetic patients treated with metformin. Diabetes Care. 2003 Jan;26(1):125-31. doi: 10.2337/diacare.26.1.125.

    PubMed 12502668

  • Love-Osborne K, Sheeder J, Zeitler P. Addition of metformin to a lifestyle modification program in adolescents with insulin resistance. J Pediatr. 2008 Jun;152(6):817-22. doi: 10.1016/j.jpeds.2008.01.018. Epub 2008 Mar 19.

    PubMed 18492523

  • Gonzalez-Ortiz M, Martinez-Abundis E, Mora-Martinez JM, Grover-Paez F. Renal handling of uric acid assessed by means of pharmacological tests in obese women. Diabetes Nutr Metab. 2001 Aug;14(4):189-94.

    PubMed 11716287

  • Clement K, Ferre P. Genetics and the pathophysiology of obesity. Pediatr Res. 2003 May;53(5):721-5. doi: 10.1203/01.PDR.0000059753.61905.58. Epub 2003 Mar 5.

    PubMed 12621112

  • Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.

    PubMed 12365955

  • Lozano Castañeda O. Adipocitoquinas. Rev Endocr Nutr. 10: 147-50, 2002.

  • Karnehed N, Rasmussen F, Hemmingsson T, Tynelius P. Obesity and attained education: cohort study of more than 700,000 Swedish men. Obesity (Silver Spring). 2006 Aug;14(8):1421-8. doi: 10.1038/oby.2006.161.

    PubMed 16988085

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sibutramine-Metformin, Sibutramine and Metformin in people with Obesity, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941382, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2009.

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