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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 University of Guadalajara
Principal Investigator: Esperanza Martínez, PHD University of 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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014