Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)

Diabetes Type 2 Clinical Trial

— DMMETclamp  

Official title:

Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940797
• Other study ID #: SIL-1099/2008
• Secondary ID: SIL-DMMETClamp
• Status: Completed
• Phase: Phase 2
• First received: July 14, 2009
• Last updated: July 15, 2009
• Start date: July 2008

Study information

• Verified date: July 2009
• Source: Laboratorios Silanes S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• 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

• AIc 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Insulin Resistance

Intervention

Drug:
• DMMET-01
60 days: 30 days; dose 1050.6 mg per day (before dinner)+ 30 days; dose 1050.6 mg twice a day 30 more days (before breakfast ando before dinner)
• Placebo
60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)

Locations

Country	Name	City	State
Mexico	Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México	Guadalajara	Jalisco

Sponsors (1)

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

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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

DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. — 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.

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	Insulin sensitivity		2 months
Secondary	Insulin, fasting glucose, HbA1c		2 months
Secondary	Adverse Events		3 months
Secondary	Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL		2 months