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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Insulin

Criteria

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