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

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00941161
First received: July 15, 2009
Last updated: May 17, 2010
Last verified: May 2010

July 15, 2009
May 17, 2010
February 2009
May 2010   (final data collection date for primary outcome measure)
fasting glucose, HbA1c [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00941161 on ClinicalTrials.gov Archive Site
total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
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

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.

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)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: metformin/glimepiride combination
    long acting metformin/glimepiride 1g/2mg
  • 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
  • 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
  • Experimental: combination
    long acting Metformin/Glimepiride
    Intervention: Drug: metformin/glimepiride combination
  • Active Comparator: metformin
    metformin hydrocloride
    Intervention: Drug: metformin
  • Active Comparator: glimepiride
    glimepiride
    Intervention: Drug: glimepiride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Not Provided
May 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00941161
DMGlime-04
Yes
Jorge Gonzalez Canudas, M.D., Laboratorios Silanes, S.A. de C.V.
Laboratorios Silanes S.A. de C.V.
Not Provided
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
Laboratorios Silanes S.A. de C.V.
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP