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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: metformin/glimepiride combination
Drug: metformin
Drug: glimepiride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • fasting glucose, HbA1c [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: February 2009
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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)

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941161

Locations
Mexico
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Study Director: Jorge Gonzalez, M.D., Master Laboratorios Silanes S.A. de C.V.
Study Chair: Manuel Gonzalez, Ph.D. Universidad de Guadalajara
Principal Investigator: Esperanza Martínez, Ph.D. Universidad de Guadalajara
  More Information

Publications:
Bailey CJ, Path MRC, Turner RC. Metformin. N Engl J Med 334: 574-579, 1996

Responsible Party: Jorge Gonzalez Canudas, M.D., Laboratorios Silanes, S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00941161     History of Changes
Other Study ID Numbers: DMGlime-04
Study First Received: July 15, 2009
Last Updated: May 17, 2010
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014