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

Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940472

Acronym

DMMET2

Enrollment

Registered

2009-07-16

Start date

2009-03-31

Completion date

Unknown

Last updated

2010-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

Keywords

type 2 diabetes, monotherapy, antidiabetics, metformin

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.

Interventions

DRUGDMMET-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).

DRUGMetformin 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)	3 months

Secondary

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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026