NCT00941239

Brief Summary

The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of an extended release metformin compared with an immediate release metformin in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2007

Shorter than P25 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

January 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

July 15, 2009

Last Update Submit

January 26, 2018

Conditions

Healthy

Keywords

Metformin ERPharmacokineticsTolerabilityHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Plasmatic drug concentration

    48 hours (7.5, 15,30,45,60,75,90,120,150,180,205,240,360,480,600,720,1440,2880 min and days : 3,5,7,14,21,28,30,35)

Secondary Outcomes (3)

  • Lanza score

    30 days (0 and 30)

  • plasmatic glucose

    30 days (0, 6, 12 and 18 hours and days: 2,5,7,14,21,28,30 and 35)

  • Glycated hemoglobin

    30 days (days: 0, 14 and 30)

Study Arms (2)

metformin ER

EXPERIMENTAL

Extended Release Metformin

Drug: metformin ER

metformin

ACTIVE COMPARATOR

Immediate release metformin

Drug: metformin

Interventions

metformin ERDRUG

850mg daily for 30 days

Also known as: predial plus
metformin ER
metforminDRUG

850 mg daily for 30 days

Also known as: extended release predial plus
metformin

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 than 10 cigarettes per day
  • History of allergy to the study drugs
  • 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

Related Publications (7)

  • Blonde L, Dailey GE, Jabbour SA, Reasner CA, Mills DJ. Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study. Curr Med Res Opin. 2004 Apr;20(4):565-72. doi: 10.1185/030079904125003278.

    PMID: 15119994BACKGROUND

  • Hale TW, Kristensen JH, Hackett LP, Kohan R, Ilett KF. Transfer of metformin into human milk. Diabetologia. 2002 Nov;45(11):1509-14. doi: 10.1007/s00125-002-0939-x. Epub 2002 Sep 25.

    PMID: 12436333BACKGROUND

  • Stumvoll M, Nurjhan N, Perriello G, Dailey G, Gerich JE. Metabolic effects of metformin in non-insulin-dependent diabetes mellitus. N Engl J Med. 1995 Aug 31;333(9):550-4. doi: 10.1056/NEJM199508313330903.

    PMID: 7623903BACKGROUND

  • Brown BW Jr. The crossover experiment for clinical trials. Biometrics. 1980 Mar;36(1):69-79.

    PMID: 7370374BACKGROUND

  • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

    PMID: 3450848BACKGROUND

  • Westlake WJ. Symmetrical confidence intervals for bioequivalence trials. Biometrics. 1976 Dec;32(4):741-4.

    PMID: 1009222BACKGROUND

  • The United States Pharmacopeia USP26. Pags 525-526. 2003. Rockville. MD.

    BACKGROUND

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Oscar Torres, Ph D

    UANL, Pharmacology and toxicology department

    PRINCIPAL INVESTIGATOR

  • Jorge A Gonzalez

    Laboratorios Silanes S.A. de C.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

January 1, 2007

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

ME(1)