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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental Drug

DMMET-01 + Diet

Group Type EXPERIMENTAL

DMMET-01

Intervention Type DRUG

90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).

Metformin

Metformin + Diet

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type DRUG

90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)

Interventions

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DMMET-01

90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).

Intervention Type DRUG

Metformin Hydrochloride

90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)

Intervention Type DRUG

Other Intervention Names

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Comparator

Eligibility Criteria

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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

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No