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

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: NCT00940472
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : May 18, 2010
Information provided by:
Laboratorios Silanes S.A. de C.V.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Type 2 Drug: DMMET-01 Drug: Metformin Hydrochloride Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Study Start Date : March 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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): 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

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
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 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