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

Overview[ - collapse ][ - ]

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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: metformin/glimepiride combination
Drug: metformin
Drug: glimepiride
PhasePhase 4
SponsorLaboratorios Silanes S.A. de C.V.
Responsible PartyLaboratorios Silanes S.A. de C.V.
ClinicalTrials.gov IdentifierNCT00941161
First ReceivedJuly 15, 2009
Last UpdatedMay 17, 2010
Last verifiedMay 2010

Tracking Information[ + expand ][ + ]

First Received DateJuly 15, 2009
Last Updated DateMay 17, 2010
Start DateFebruary 2009
Estimated Primary Completion DateNot Provided
Current Primary Outcome Measuresfasting glucose, HbA1c [Time Frame: three months] [Designated as safety issue: Yes]
Current Secondary Outcome Measurestotal cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [Time Frame: three months] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleEffect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Official TitleEffect 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
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.
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)
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: 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
Study Arm (s)
  • Experimental: combination
    long acting Metformin/Glimepiride
  • Active Comparator: metformin
    metformin hydrocloride
  • Active Comparator: glimepiride
    glimepiride

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment28
Estimated Completion DateNot Provided
Estimated Primary Completion DateMay 2010
Eligibility 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
GenderBoth
Ages40 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMexico

Administrative Information[ + expand ][ + ]

NCT Number NCT00941161
Other Study ID NumbersDMGlime-04
Has Data Monitoring CommitteeYes
Information Provided ByLaboratorios Silanes S.A. de C.V.
Study SponsorLaboratorios Silanes S.A. de C.V.
CollaboratorsNot Provided
Investigators Study Director: Jorge Gonzalez, M.D., Master Laboratorios Silanes S.A. de C.V.Study Chair: Manuel Gonzalez, Ph.D. Universidad de GuadalajaraPrincipal Investigator: Esperanza Martínez, Ph.D. Universidad de Guadalajara
Verification DateMay 2010

Locations[ + expand ][ + ]

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico