Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)

Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00940797

Acronym

DMMETclamp

Enrollment

Registered

2009-07-16

Start date

2008-07-31

Completion date

Unknown

Last updated

2009-07-16

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

Conditions

Diabetes Type 2

Keywords

diabetes, Type 2, monotherapy, antidiabetics, metformin

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.

Interventions

DRUGDMMET-01

60 days: 30 days; dose 1050.6 mg per day (before dinner)+ 30 days; dose 1050.6 mg twice a day 30 more days (before breakfast ando before dinner)

DRUGPlacebo

60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and 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 * 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 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
Insulin sensitivity	2 months

Secondary

Measure	Time frame
Insulin, fasting glucose, HbA1c	2 months
Adverse Events	3 months
Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL	2 months

Countries

Mexico

Outcome results

None listed

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