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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00940797
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : July 16, 2009
Information provided by:
Laboratorios Silanes S.A. de C.V.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Type 2 Drug: DMMET-01 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : July 2008
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 2 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 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