Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.

The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.

Inclusion Criteria:

• Ages eligible for study: 40 to 60 years
• With type 2 diabetes evolution < 5 years without pharmacological treatment 1 month prior to the screening
• Fasting glucose = 130-200 mg/dL
• HbA1c of 7% to 9%
• Blood pressure < 140/80 mmHg
• Ability to communicate and meet the requirements of the study
• Signed Written Informed Consent before to conducting any study
• Body mass index (BMI) of 25 kg/m2 to 35 Kg/m2

Exclusion Criteria:

• Suspected or confirmed pregnancy
• Nursing
• Inability to secure the non-pregnant during the study duration
• Hypersensitivity to any biguanides
• Use of an investigational drug within 30 days prior to the screening
• Liver failure, heart failure, kidney failure or thyroid disease
• Periods of acute or chronic diarrhea or vomiting
• Chronic hepatic disease
• Total Cholesterol >300 mg/dL
• Triglycerides >400 mg/dL