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

Diabetes Type 2 Clinical Trial

— DMMET2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940472
• Other study ID #: SIL-0790/2009
• Secondary ID: SIL-DMMET080609
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 14, 2009
• Last updated: May 17, 2010
• Start date: March 2009

Study information

• Verified date: May 2010
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthMexico: Federal Commission for Protection Against Health RisksMexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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).
• 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)

Locations

Country	Name	City	State
Mexico	Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara	Guadalajara	Jal

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Silanes S.A. de C.V.

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Aguilar-Salinas CA, Velazquez Monroy O, Gómez-Pérez FJ, Gonzalez Chávez 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 México: Results from a large population-based nationwide survey. Diabetes Care. 2003 Jul;26(7):2021-6. — View Citation

American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. — View Citation

González-Ortiz M, Martínez-Abundis E, Kam-Ramos AM, Hernández-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. — View Citation

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; 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)		3 months	No
Secondary	Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)		3 months	Yes
Secondary	Adverse Events		4 months	Yes