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Gastric Tolerability and Pharmacokinetics of DMMET-01

This study has been completed.
Information provided by:
Laboratorios Silanes S.A. de C.V. Identifier:
First received: August 14, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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 Intervention Phase
Drug: DMMET-01
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:
  • 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:
  • Lanza score [ Time Frame: 30 days (0 and 30) ]
  • plasmatic glucose [ Time Frame: 24 hours (6,12,18 and 24) ]
  • glycated hemoglobin [ Time Frame: 24 hours (0 and 24) ]

Enrollment: 12
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMMET-01 Drug: DMMET-01
1050.6 mg daily for 30 days


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
  Contacts and Locations
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Please refer to this study by its identifier: 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.
  More Information

Responsible Party: Dr. Jorge González Canudas, Laboratorios Silanes S.A. de C.V. Identifier: NCT00960882     History of Changes
Other Study ID Numbers: DMMET 1011/07
Study First Received: August 14, 2009
Last Updated: August 14, 2009

Keywords provided by Laboratorios Silanes S.A. de C.V.:
gastric tolerability processed this record on May 25, 2017