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

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00940797
First received: July 14, 2009
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
Drug: DMMET-01
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique

Resource links provided by NLM:


Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin, fasting glucose, HbA1c [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: July 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMMET-01 Drug: DMMET-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)
Placebo Comparator: Control Drug: Placebo
60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940797

Locations
Mexico
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Investigators
Study Director: Jorge A González, MD Laboratorios Silanes S.A. de C.V.
Study Chair: Manuel Gonzalez, PHD Universidad de Guadalajara
Principal Investigator: Esperanza Martínez, PHD Universidad de Guadalajara
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jorge González Canudas/Medical director, Silanes
ClinicalTrials.gov Identifier: NCT00940797     History of Changes
Other Study ID Numbers: SIL-1099/2008, SIL-DMMETClamp
Study First Received: July 14, 2009
Last Updated: July 15, 2009
Health Authority: Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Laboratorios Silanes S.A. de C.V.:
diabetes
Type 2
monotherapy
antidiabetics
metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on April 21, 2014