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Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients (DMMET2)

This study has been completed.
Information provided by:
Laboratorios Silanes S.A. de C.V. Identifier:
First received: July 14, 2009
Last updated: May 17, 2010
Last verified: May 2010
The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.

Condition Intervention Phase
Diabetes Type 2 Drug: DMMET-01 Drug: Metformin Hydrochloride Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Metabolic Control (Fasting glucose, postprandial glucose, HbA1C) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Lipid Profile (Total cholesterol, HDL, LDL, triglycerides) [ Time Frame: 3 months ]
  • Adverse Events [ Time Frame: 4 months ]

Estimated Enrollment: 20
Study Start Date: March 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug
DMMET-01 + Diet
Drug: DMMET-01
90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).
Active Comparator: Metformin
Metformin + Diet
Drug: Metformin Hydrochloride
90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)
Other Name: Comparator


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
  • HbA1c 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: NCT00940472

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara
Guadalajara, Jal, 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 González, PHD University of Guadalajara
Principal Investigator: Esperanza Martínez, PHD University of Guadalajara
  More Information

González-Ortiz M, Martínez-Abundis E. Síndrome de resistencia a la insulina. En, Diabetes mellitus. Islas-Andrade S, Revilla-Monsalve C. McGrawHill-Interamericana. 3a. edición. México, 2005. ISBN p. 203-14.

Responsible Party: Jorge González Canudas/Medical director, Silanes Identifier: NCT00940472     History of Changes
Other Study ID Numbers: SIL-0790/2009
Study First Received: July 14, 2009
Last Updated: May 17, 2010

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017