Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

Phase 2

Completed

• Conditions: Diabetes Type 2
• Interventions: Drug: DMMET-01; Drug: Metformin Hydrochloride

• Registration Number: NCT00940472
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2009-12
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-18

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
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Drug	DMMET-01	DMMET-01 + Diet
Metformin	Metformin Hydrochloride	Metformin + Diet

Primary Outcome Measures

Name	Time	Method
Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)	3 months

Secondary Outcome Measures

Name	Time	Method
Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)	3 months
Adverse Events	4 months

Trial Locations

Locations (1)

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara; 🇲🇽 Guadalajara, Jal, Mexico