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Completed

NCT Number: NCT00940797

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMMET-01

Drug

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)

Placebo

Drug

60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)

Primary outcomes

  1. Insulin sensitivity

    Time frame: 2 months

Secondary outcomes

  1. Insulin, fasting glucose, HbA1c

    Time frame: 2 months

  2. Adverse Events

    Time frame: 3 months

  3. Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Laboratorios Silanes S.A. de C.V.

Industry

Registry information

Official study title

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

Acronym: DMMETclamp

Important dates

Study start
2008
Primary completion
2009
First posted
Jul 16, 2009
Registry last updated
Jul 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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