Status:
COMPLETED
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Diabetes Type 2
Eligibility:
All Genders
40-60 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00940797
Start Date
July 1 2008
Last Update
July 16 2009
Active Locations (1)
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1
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México
Guadalajara, Jalisco, Mexico, 44340