Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP) (DMMETclamp)

Laboratorios Silanes

Status and phase: Completed; Phase 2

Conditions: Diabetes Type 2

Treatments: Drug: DMMET-01; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940797

SIL-1099/2008

SIL-DMMETClamp

Details and patient eligibility

About

The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.

Enrollment: 20 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
• AIc 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, including a placebo group

DMMET-01

Experimental group

Treatment:

Drug: DMMET-01

Control

Placebo Comparator group

Treatment:

Drug: Placebo