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CompletedNCT00960882Updated Jan 30, 2018

Gastric Tolerability and Pharmacokinetics of DMMET-01

A Phase 1 interventional study of DMMET-01 in Healthy, sponsored by Laboratorios Silanes S.A. de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Laboratorios Silanes S.A. de C.V. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Pharmacokinetics
  • Diabetes
  • gastric tolerability
03

In context

Lead sponsor

Laboratorios Silanes S.A. de C.V. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    DMMET-01

    Drug: DMMET-01

Interventions

  • DrugDMMET-01

    1050.6 mg daily for 30 days

06

What researchers measure

Primary outcomes

  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 outcomes

  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)

07

Study locations

1 site
  • Pharmacology and toxicology department, UANL
    Monterrey, Nuevo León 64460, Mexico
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00960882
Lead sponsor
Laboratorios Silanes S.A. de C.V.
Responsible party
Sponsor
First posted
Aug 18, 2009
Start date
Jun 2007
Primary completion
Mar 2008
Completion
Apr 2008
Last update
Jan 30, 2018

Study contacts

Oscar Torres, PhD
principal investigator · UANL, Pharmacology and toxicology department
Jorge A Gonzalez, Master
study director · Laboratorios Silanes S.A. de C.V.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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