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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.
Sponsor:
Information provided by:
Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00940472
First received: July 14, 2009
Last updated: May 17, 2010
Last verified: May 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

  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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940472

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

Publications:
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.
González-Ortiz M, Martínez-Abundis E, A Nombre del Grupo para el Tratamiento de la Diabetes Mellitus con Combinaciones. Eficacia y Seguridad de la Combinación de Glimepirida y Metformina en una Sola Forma Farmacéutica en Pacientes con Falla a la terapia con Glibenclamida. Rev Invest Clin 2004; 56: 327-333
American Diabetes Association. Standards of medical care in diabetes - 2007. Diabetes Care 2007; 30: S4-S41.

Responsible Party: Jorge González Canudas/Medical director, Silanes
ClinicalTrials.gov Identifier: NCT00940472     History of Changes
Other Study ID Numbers: SIL-0790/2009, SIL-DMMET080609
Study First Received: July 14, 2009
Last Updated: May 17, 2010
Health Authority: Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013