Gastric Tolerability and Pharmacokinetics of DMMET-01

Gastric Tolerability and Pharmacokinetics of DMMET-01. Daily Intake for 30 Days, in Normal Alimentation Conditions, in Healthy Volunteers.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DMMET-01

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DMMET-01	Drug: DMMET-01; 1050.6 mg daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Lanza score	30 days (0 and 30)
plasmatic glucose	24 hours (6,12,18 and 24)
glycated hemoglobin	24 hours (0 and 24)

Collaborators and Investigators

• Sponsor: Laboratorios Silanes S.A. de C.V.
• Investigators: Principal Investigator: Oscar Torres, PhD, UANL, Pharmacology and toxicology department; Study Director: Jorge A Gonzalez, Master, Laboratorios Silanes S.A. de C.V.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: August 14, 2009
• First Submitted That Met QC Criteria: August 14, 2009
• First Posted (Estimate): August 18, 2009

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Diabetes; Pharmacokinetics; gastric tolerability
• Other Study ID Numbers: DMMET 1011/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided