Gastric Tolerability and Pharmacokinetics of DMMET-01 | NCT00960882

Studies
Gastric Tolerability and Pharmacokinetics of DMMET-01

NCT00960882

Sponsor

Laboratorios Silanes S.A. de C.V.

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DMMET-01

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Aug 14, 2009

First Submission Date that Met QC Criteria

Aug 14, 2009

First Posted Date

Aug 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2018

Last Update Posted Date

Jan 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DMMET-01	Experimental		Drug: DMMET-01

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DMMET-01	Drug	1050.6 mg daily for 30 days	DMMET-01

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oscar Torres, PhD	UANL, Pharmacology and toxicology department	Principal Investigator
Jorge A Gonzalez, Master	Laboratorios Silanes S.A. de C.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pharmacology and toxicology department, UANL		Monterrey	Nuevo León	64460	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided