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

This study has been completed.
Information provided by:
Laboratorios Silanes S.A. de C.V. Identifier:
First received: July 14, 2009
Last updated: July 15, 2009
Last verified: July 2009
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Insulin, fasting glucose, HbA1c [ Time Frame: 2 months ]
  • Adverse Events [ Time Frame: 3 months ]
  • Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL [ Time Frame: 2 months ]

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)


Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00940797

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.
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jorge González Canudas/Medical director, Silanes Identifier: NCT00940797     History of Changes
Other Study ID Numbers: SIL-1099/2008
Study First Received: July 14, 2009
Last Updated: July 15, 2009

Keywords provided by Laboratorios Silanes S.A. de C.V.:
Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on August 18, 2017