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

NCT00940472 | Completed Phase 2

• 2 other identifiers: SIL-0790/2009SIL-DMMET080609
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type 2

Keywords

type 2 diabetes; monotherapy; antidiabetics; metformin

Outcome Measures

Primary Outcomes (1)

• Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)

  3 months

Secondary Outcomes (2)

• Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)

  3 months

• Adverse Events

  4 months

Study Arms (2)

Experimental Drug

EXPERIMENTAL

DMMET-01 + Diet

Drug: DMMET-01

Metformin

ACTIVE COMPARATOR

Metformin + Diet

Drug: Metformin Hydrochloride

Interventions

DMMET-01 DRUG

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).

Experimental Drug

Metformin Hydrochloride DRUG

90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)

Also known as: Comparator

Metformin

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (7)

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Aguilar-Salinas CA, Velazquez Monroy O, Gomez-Perez FJ, Gonzalez Chavez A, Esqueda AL, Molina Cuevas V, Rull-Rodrigo JA, Tapia Conyer R; Encuesta Nacional de Salud 2000 Group. Characteristics of patients with type 2 diabetes in Mexico: Results from a large population-based nationwide survey. Diabetes Care. 2003 Jul;26(7):2021-6. doi: 10.2337/diacare.26.7.2021.

  PMID: 12832306 BACKGROUND

• 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.

  BACKGROUND

• Gonzalez-Ortiz M, Martinez-Abundis E, Kam-Ramos AM, Hernandez-Salazar E, Ramos-Zavala MG. Effect of ezetimibe on insulin sensitivity and lipid profile in obese and dyslipidaemic patients. Cardiovasc Drugs Ther. 2006 Apr;20(2):143-6. doi: 10.1007/s10557-006-7805-x.

  PMID: 16761194 BACKGROUND

• Gonzalez-Ortiz M, Martinez-Abundis E; Grupo para el Tratamiento de la Diabetes Mellitus con Combinaciones. [Efficacy and safety of glimepiride plus metformin in a single presentation, as combined therapy, in patients with type 2 diabetes mellitus and secondary failure to glibenclamide, as monotherapy]. Rev Invest Clin. 2004 May-Jun;56(3):327-33. Spanish.

  PMID: 15612515 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.

  PMID: 17192377 BACKGROUND

• Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.

  PMID: 2753525 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jorge A González, MD

  Laboratorios Silanes S.A. de C.V.

  STUDY DIRECTOR

• Manuel González, PHD

  University of Guadalajara

  STUDY CHAIR

• Esperanza Martínez, PHD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: July 16, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: May 18, 2010

Record last verified: 2010-05

Locations

ME (1)