Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
- Registration Number
- NCT00940797
- Lead Sponsor
- Laboratorios Silanes S.A. de C.V.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DMMET-01 DMMET-01 - Control Placebo -
- Primary Outcome Measures
Name Time Method Insulin sensitivity 2 months
- Secondary Outcome Measures
Name Time Method Insulin, fasting glucose, HbA1c 2 months Adverse Events 3 months Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL 2 months
Trial Locations
- Locations (1)
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México
🇲🇽Guadalajara, Jalisco, Mexico