Gastric Tolerability and Pharmacokinetics of DMMET-01

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00960882
Recruitment Status : Completed
First Posted : August 18, 2009
Last Update Posted : January 30, 2018
Information provided by (Responsible Party):
Laboratorios Silanes S.A. de C.V.

Brief Summary:
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: DMMET-01 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.
Study Start Date : June 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: DMMET-01 Drug: DMMET-01
1050.6 mg daily for 30 days

Primary Outcome Measures :
  1. DMMET-01 Plasmatic concentration [ Time Frame: 48 hrs (7.5; 15; 30; 45; 60; 75; 90; 120; 150; 180; 205; 240; 360; 480; 600; 720; 1440 and 2880 min) ]

Secondary Outcome Measures :
  1. Lanza score [ Time Frame: 30 days (0 and 30) ]
  2. plasmatic glucose [ Time Frame: 24 hours (6,12,18 and 24) ]
  3. glycated hemoglobin [ Time Frame: 24 hours (0 and 24) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Mexican healthy subjects with normal clinical laboratory test results and imaging (hematology, blood chemistry, urine test, VDRL, Hepatitis B, HIV, chest radiography and electrocardiogram)

Exclusion Criteria:

  • Familiar or personal history of diabetes
  • History of drug or alcohol abuse within the 2 years prior to the study
  • A smoking habit greater tha 10 cigarettes per day
  • Intercurrent disease
  • Intercurrent treatment with any drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00960882

Pharmacology and toxicology department, UANL
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Laboratorios Silanes S.A. de C.V.
Principal Investigator: Oscar Torres, PhD UANL, Pharmacology and toxicology department
Study Director: Jorge A Gonzalez, Master Laboratorios Silanes S.A. de C.V.

Responsible Party: Laboratorios Silanes S.A. de C.V. Identifier: NCT00960882     History of Changes
Other Study ID Numbers: DMMET 1011/07
First Posted: August 18, 2009    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Laboratorios Silanes S.A. de C.V.:
gastric tolerability