Status:
COMPLETED
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Diabetes Type 2
Eligibility:
All Genders
40-60 years
Phase:
PHASE2
PHASE3
Brief Summary
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.
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
- 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
- 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 :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00940472
Start Date
March 1 2009
Last Update
May 18 2010
Active Locations (1)
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1
Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Guadalajara, Jalisco, Mexico, 44340