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
  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:


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
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: 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 University of Guadalajara
Principal Investigator: Esperanza Martínez, PHD University of 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 July 22, 2014