Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Gestational Diabetes; Diabetes

Treatments: Drug: human insulin; Drug: insulin NPH; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00065130

ANA-2067

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether NovoLog (insulin aspart) is a safe and at least as effective alternative to regular human insulin for the control of blood glucose after meals in women who develop diabetes during pregnancy.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subjects older than 35 years old will be considered
• Gestational diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)