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

This study has been completed.

Sponsor:

Information provided by:

Laboratorios Silanes S.A. de C.V.

ClinicalTrials.gov Identifier:

NCT00940797

First received: July 14, 2009

Last updated: July 15, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 14, 2009

Last Updated Date

July 15, 2009

Start Date ^ICMJE

July 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Insulin sensitivity [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00940797 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Insulin, fasting glucose, HbA1c [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Type 2

Intervention ^ICMJE

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)
Drug: Placebo
60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)

Study Arm (s)

Experimental: DMMET-01
Intervention: Drug: DMMET-01
Placebo Comparator: Control
Intervention: Drug: Placebo

Publications *

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.
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.
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.
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.
González-Ortiz M, Martínez-Abundis E, Robles-Cervantes JA, Ramos-Zavala MG, Barrera-Durán C, González-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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mexico

Administrative Information

NCT Number ^ICMJE

NCT00940797

Other Study ID Numbers ^ICMJE

SIL-1099/2008, SIL-DMMETClamp

Has Data Monitoring Committee

Responsible Party

Jorge González Canudas/Medical director, Silanes

Study Sponsor ^ICMJE

Laboratorios Silanes S.A. de C.V.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Jorge A González, MD	Laboratorios Silanes S.A. de C.V.
Study Chair:	Manuel Gonzalez, PHD	Universidad de Guadalajara
Principal Investigator:	Esperanza Martínez, PHD	Universidad de Guadalajara

Information Provided By

Laboratorios Silanes S.A. de C.V.

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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