NCT00940797

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
Last Updated

July 16, 2009

Status Verified

July 1, 2009

Enrollment Period

7 months

First QC Date

July 14, 2009

Last Update Submit

July 15, 2009

Conditions

Diabetes Type 2

Keywords

diabetesType 2monotherapyantidiabeticsmetformin

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    2 months

Secondary Outcomes (3)

  • Insulin, fasting glucose, HbA1c

    2 months

  • Adverse Events

    3 months

  • Creatinine, Total Cholesterol, HDL, Triglycerides, Uric acid, AST, ALT, FA, DHL

    2 months

Study Arms (2)

DMMET-01

EXPERIMENTAL
Drug: DMMET-01

Control

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DMMET-01DRUG

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)

DMMET-01
PlaceboDRUG

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

Control

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 15111519BACKGROUND

  • 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.

    PMID: 12832306BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 382871BACKGROUND

  • 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.

    PMID: 22974412DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jorge A González, MD

    Laboratorios Silanes S.A. de C.V.

    STUDY DIRECTOR

  • Manuel Gonzalez, PHD

    University of Guadalajara

    STUDY CHAIR

  • Esperanza Martínez, PHD

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 16, 2009

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Last Updated

July 16, 2009

Record last verified: 2009-07

Locations

ME(1)