NCT00065130

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3 diabetes

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

April 1, 2000

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

July 17, 2003

Last Update Submit

December 21, 2016

Conditions

DiabetesGestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycemic control

Secondary Outcomes (4)

  • HbA1c (glycosylated haemoglobin A1c)

  • Postprandial endogenous insulin secretory response

  • Hypoglycemic episodes

  • Adverse events

Interventions

human insulinDRUG
insulin NPHDRUG
insulin aspartDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Santa Barbara, California, 93105, United States

Location

Related Publications (2)

  • Pettitt DJ, Ospina P, Kolaczynski JW, Jovanovic L. Comparison of an insulin analog, insulin aspart, and regular human insulin with no insulin in gestational diabetes mellitus. Diabetes Care. 2003 Jan;26(1):183-6. doi: 10.2337/diacare.26.1.183.

    PMID: 12502678RESULT

  • Pettitt DJ, Ospina P, Howard C, Zisser H, Jovanovic L. Efficacy, safety and lack of immunogenicity of insulin aspart compared with regular human insulin for women with gestational diabetes mellitus. Diabet Med. 2007 Oct;24(10):1129-35. doi: 10.1111/j.1464-5491.2007.02247.x.

    PMID: 17888133RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes, Gestational

Interventions

InsulinInsulin, IsophaneInsulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-ActingInsulin, Short-Acting

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2003

First Posted

July 18, 2003

Study Start

April 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

US(1)