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OpenTrials
Completed

NCT Number: NCT00065130

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Santa Barbara, California, 93105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

human insulin

Drug

insulin NPH

Drug

insulin aspart

Drug

Primary outcomes

  1. Postprandial glycemic control

Secondary outcomes

  1. HbA1c (glycosylated haemoglobin A1c)

  2. Postprandial endogenous insulin secretory response

  3. Hypoglycemic episodes

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Basal/Bolus Therapy for Patients With Gestational Diabetes

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Jul 18, 2003
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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