NCT00371306

Brief Summary

Pregnant women with gestational or Type 2 diabetes who require medication are placed in one of two groups: Insulin injections or Glucovance (oral administration). Blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels. The hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 20, 2007

Status Verified

April 1, 2007

First QC Date

September 1, 2006

Last Update Submit

April 19, 2007

Conditions

Gestational DiabetesType 2 DiabetesPregnancy

Keywords

DiabetesPregnancy

Outcome Measures

Primary Outcomes (3)

  • Maternal hemoglobin A1C at delivery

  • Maternal fructosamine at delivery

  • Maternal glucose at delivery

Secondary Outcomes (4)

  • Mode of delivery

  • Infant birth weight

  • Infant initial glucose

  • Infant complications

Interventions

Insulin versus glucovance (glyburide/metformin)DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Obstetrical Consultants

Chattanooga, Tennessee, 37403, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Diabetes Mellitus

Interventions

GlyburideMetformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsUreaAmidesOrganic ChemicalsSulfonesSulfur CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Joseph H Kipikasa, MD

    Regional Obstetrical Consultants; UT Chattanooga OB-GYN Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorrie A Mason, MSN

CONTACT

423 664-4460lorrie@rocob.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

September 1, 2002

Study Completion

September 1, 2008

Last Updated

April 20, 2007

Record last verified: 2007-04

Locations

US(1)