Clinical trial NCT00940797: Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
Official title: Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Type 2
Keywords: diabetes
Type 2
monotherapy
antidiabetics
metformin
Lead sponsor: Laboratorios Silanes S.A. de C.V.
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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
* 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 2 months
Secondary outcomes:
measure: Insulin, fasting glucose, HbA1c
timeFrame: 2 months
measure: Adverse Events
timeFrame: 3 months
measure: Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL
timeFrame: 2 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México
state: Jalisco
Study officials:
affiliation: Laboratorios Silanes S.A. de C.V.
name: Jorge A González, MD
role: STUDY_DIRECTOR
affiliation: University of Guadalajara
name: Manuel Gonzalez, PHD
role: STUDY_CHAIR
affiliation: University of Guadalajara
name: Esperanza Martínez, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.2337/diacare.27.5.1047.
citation: 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.
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.
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. doi: 10.1152/ajpendo.1979.237.3.E214.
citation: Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Duran C, Gonzalez-Canudas J. Effect of metformin glycinate on glycated hemoglobin A1C concentration and insulin sensitivity in drug-naive adult patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2012 Dec;14(12):1140-4. doi: 10.1089/dia.2012.0097. Epub 2012 Sep 13.