Clinical trial NCT00941161: Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: fasting glucose, HbA1c
timeFrame: three months
Secondary outcomes:
measure: total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin
timeFrame: three months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
state: Jalisco
Study officials:
affiliation: Laboratorios Silanes S.A. de C.V.
name: Jorge Gonzalez, M.D., Master
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: Manuel Gonzalez, Ph.D.
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Esperanza Martínez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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