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

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
DMMET-01
Placebo
Sponsored by
Laboratorios Silanes S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring diabetes, Type 2, monotherapy, antidiabetics, metformin

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DMMET-01

Control

Arm Description

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Insulin, fasting glucose, HbA1c
Adverse Events
Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL

Full Information

First Posted
July 14, 2009
Last Updated
July 15, 2009
Sponsor
Laboratorios Silanes S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00940797
Brief Title
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients (CLAMP)
Acronym
DMMETclamp
Official Title
Effect of DMMET-01 on Insulin Sensitivity in Naive Type 2 Diabetes Patients by Glucose CLAMP Technique
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratorios Silanes S.A. de C.V.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
diabetes, Type 2, monotherapy, antidiabetics, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMMET-01
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DMMET-01
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
60 days: 30 days placebo once a day (before dinner) + 30 days twice a day (before breakfast and before dinner)
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Insulin, fasting glucose, HbA1c
Time Frame
2 months
Title
Adverse Events
Time Frame
3 months
Title
Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge A González, MD
Organizational Affiliation
Laboratorios Silanes S.A. de C.V.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuel Gonzalez, PHD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez, PHD
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, México
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
15111519
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.
Results Reference
background
PubMed Identifier
12832306
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
382871
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.
Results Reference
background
PubMed Identifier
22974412
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.
Results Reference
derived

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

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