Recruiting

Glucovance vs. Insulin

Sponsor:

Regional Obstetrical Consultants

Code:

NCT00371306

Conditions

Gestational Diabetes

Type 2 Diabetes

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Insulin versus glucovance (glyburide/metformin)

Study Details

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.

Conditions

Gestational Diabetes

Type 2 Diabetes

Pregnancy

Study ID

NCT00371306

Start date

Sep, 2002

Status verified date

Apr, 2007

Completion date

Sep, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:Gestational diabetes by ACOG definition or Type 2 diabetes in pregnancy Hyperglycemia despite following ADA diet English or Spanish speaking -

Exclusion Criteria:Already requiring Insulin Serum creatinine > 1.3 or creatinine clearance < 75ml/minute Liver disease

-

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Insulin versus glucovance (glyburide/metformin)

Primary outcome measure

  • Maternal hemoglobin A1C at delivery [ Time Frame: undefined ]
  • Maternal fructosamine at delivery [ Time Frame: undefined ]
  • Maternal glucose at delivery [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Lorrie A Mason, MSN

423 664-4460lorrie@rocob.com

Locations

Regional Obstetrical Consultants

Recruiting

Chattanooga, Tennessee, United States, 37403

More Information

Sponsor

Regional Obstetrical Consultants

Last update posted

Apr 20, 2007

Last verified

Apr, 2007

Keywords

  • Diabetes
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regional Obstetrical Consultants on 2007-04-20.