We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

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.
ClinicalTrials.gov Identifier: NCT00941161
Recruitment Status : Completed
First Posted : July 17, 2009
Last Update Posted : May 18, 2010
Information provided by:
Laboratorios Silanes S.A. de C.V.

Brief Summary:
The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: metformin/glimepiride combination Drug: metformin Drug: glimepiride Phase 4

Detailed Description:
A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Oral Combination Therapy of Metformin Extended Release Over Glimepiride in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus With Failure of Monotherapy
Study Start Date : February 2009
Actual Primary Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: combination
long acting Metformin/Glimepiride
Drug: metformin/glimepiride combination
long acting metformin/glimepiride 1g/2mg

Active Comparator: metformin
metformin hydrocloride
Drug: metformin
long acting metformin 1g once a day with fasting glucose 130-199mg/dL or long actin metformin 1g twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL

Active Comparator: glimepiride
Drug: glimepiride
glimepiride 2mg once a day with fasting glucose 130-199mg/dL, or glimepiride 2mg twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL

Primary Outcome Measures :
  1. fasting glucose, HbA1c [ Time Frame: three months ]

Secondary Outcome Measures :
  1. total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40 to 65 years old
  • Ability to communicate and to meet the requirements of the study
  • Signed Written Informed Consent before to conducting any study
  • Body Mass Index (BMI) = 25-40kg/m2
  • Stable weight in the past three months (variability <5%)
  • Meal plan and monotherapy with oral hypoglycaemic fails
  • Fasting glucose = 130-270 mg/dL
  • HbA1c > 7%
  • isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three days prior to making the laboratory tests

Exclusion Criteria:

  • Suspected or confirmed pregnancy
  • Nursing
  • Inability to secure the non-pregnant during the study duration
  • Hypersensitivity to any of the drugs under study
  • Treatment with oral hypoglycemic or insulin
  • Consumption of substance with toxic effects on any organ system
  • Liver failure, heart failure, kidney failure or thyroid disease
  • Chronic intake of alcohol
  • Periods of acute or chronic diarrhea or vomiting
  • Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride, digoxin, procainamide, quinidine, quinine, triamterene and vancomycin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941161

Layout table for location information
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Layout table for investigator information
Study Director: Jorge Gonzalez, M.D., Master Laboratorios Silanes S.A. de C.V.
Study Chair: Manuel Gonzalez, Ph.D. University of Guadalajara
Principal Investigator: Esperanza Martínez, Ph.D. University of Guadalajara
International Diabetes Federation / International Association for the Study of Obesity. Diabetes and Obesity 11-21, 2004

Layout table for additonal information
Responsible Party: Jorge Gonzalez Canudas, M.D., Laboratorios Silanes, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00941161    
Other Study ID Numbers: DMGlime-04
First Posted: July 17, 2009    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors