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Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients (DMMET2)

Primary Purpose

Diabetes Type 2

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
DMMET-01
Metformin Hydrochloride
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 type 2 diabetes, 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
  • HbA1c 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Drug

Metformin

Arm Description

DMMET-01 + Diet

Metformin + Diet

Outcomes

Primary Outcome Measures

Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)

Secondary Outcome Measures

Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)
Adverse Events

Full Information

First Posted
July 14, 2009
Last Updated
May 17, 2010
Sponsor
Laboratorios Silanes S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00940472
Brief Title
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients
Acronym
DMMET2
Official Title
Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 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 clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Drug
Arm Type
Experimental
Arm Description
DMMET-01 + Diet
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin + Diet
Intervention Type
Drug
Intervention Name(s)
DMMET-01
Intervention Description
90 days: 15 days daily dose 1050.6 mg (before dinner)+75 days dose twice a day 1050.6 mg (before breakfast) 1050.6 mg (before dinner).
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride
Other Intervention Name(s)
Comparator
Intervention Description
90 days: 15 days daily dose 850 mg (before dinner)+ 75 days dose twice a day 850 mg (before breakfast) 850 mg (before dinner)
Primary Outcome Measure Information:
Title
Metabolic Control (Fasting glucose, postprandial glucose, HbA1C)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lipid Profile (Total cholesterol, HDL, LDL, triglycerides)
Time Frame
3 months
Title
Adverse Events
Time Frame
4 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 HbA1c 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 González, 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
City
Guadalajara
State/Province
Jal
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
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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
16761194
Citation
Gonzalez-Ortiz M, Martinez-Abundis E, Kam-Ramos AM, Hernandez-Salazar E, Ramos-Zavala MG. Effect of ezetimibe on insulin sensitivity and lipid profile in obese and dyslipidaemic patients. Cardiovasc Drugs Ther. 2006 Apr;20(2):143-6. doi: 10.1007/s10557-006-7805-x.
Results Reference
background
PubMed Identifier
15612515
Citation
Gonzalez-Ortiz M, Martinez-Abundis E; Grupo para el Tratamiento de la Diabetes Mellitus con Combinaciones. [Efficacy and safety of glimepiride plus metformin in a single presentation, as combined therapy, in patients with type 2 diabetes mellitus and secondary failure to glibenclamide, as monotherapy]. Rev Invest Clin. 2004 May-Jun;56(3):327-33. Spanish.
Results Reference
background
PubMed Identifier
17192377
Citation
American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
Results Reference
background
PubMed Identifier
2753525
Citation
Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.
Results Reference
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Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients

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