Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients (DMMET2)

Laboratorios Silanes

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Type 2

Treatments: Drug: DMMET-01; Drug: Metformin Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940472

SIL-DMMET080609

SIL-0790/2009

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Experimental Drug

Experimental group

Description:

DMMET-01 + Diet

Treatment:

Drug: DMMET-01

Metformin

Active Comparator group

Description:

Metformin + Diet

Treatment:

Drug: Metformin Hydrochloride