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

Laboratorios Silanes

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: metformin; Drug: glimepiride; Drug: metformin/glimepiride combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941161

DMGlime-04

Details and patient eligibility

About

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.

Full 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)

Enrollment: 28 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 3 patient groups

combination

Experimental group

Description:

long acting Metformin/Glimepiride

Treatment:

Drug: metformin/glimepiride combination

metformin

Active Comparator group

Description:

metformin hydrocloride

Treatment:

Drug: metformin

glimepiride

Active Comparator group

Description:

glimepiride

Treatment:

Drug: glimepiride