NCT00960882

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_1 healthy

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

June 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

August 14, 2009

Last Update Submit

January 26, 2018

Conditions

Healthy

Keywords

PharmacokineticsDiabetesgastric tolerability

Outcome Measures

Primary Outcomes (1)

  • DMMET-01 Plasmatic concentration

    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 (3)

  • Lanza score

    30 days (0 and 30)

  • plasmatic glucose

    24 hours (6,12,18 and 24)

  • glycated hemoglobin

    24 hours (0 and 24)

Study Arms (1)

DMMET-01

EXPERIMENTAL
Drug: DMMET-01

Interventions

DMMET-01DRUG

1050.6 mg daily for 30 days

DMMET-01

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacology and toxicology department, UANL

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Oscar Torres, PhD

    UANL, Pharmacology and toxicology department

    PRINCIPAL INVESTIGATOR

  • Jorge A Gonzalez, Master

    Laboratorios Silanes S.A. de C.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 18, 2009

Study Start

June 1, 2007

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

ME(1)