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

July 14, 2009
July 15, 2009
July 2008
February 2009   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940797 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Type 2
  • 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)
  • Drug: Placebo
    60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)
  • Experimental: DMMET-01
    Intervention: Drug: DMMET-01
  • Placebo Comparator: Control
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
February 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT00940797
SIL-1099/2008, SIL-DMMETClamp
No
Jorge González Canudas/Medical director, Silanes
Laboratorios Silanes S.A. de C.V.
Not Provided
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
Laboratorios Silanes S.A. de C.V.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP