NCT00474045|CompletedPhase 3ResultsDMC

Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes

A Randomised, Parallel-group, Open-labelled, Multinational Trial Comparing the Efficacy and Safety of Insulin Detemir (Levemir®) Versus Human Insulin (NPH Insulin), Used in Combination With Insulin Aspart as Bolus Insulin, in the Treatment of Pregnant Women With Type 1 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN304-16872006-004861-33

Study Type

interventional

Target

470

Locations

16 countries

Sites

Timeline

RegisteredMay 2007

StartedMay 2007

CompletionAug 2010

Brief Summary

This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

Trial Health

On Track

Trial Health Score

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

Enrollment

470

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started May 2007

Longer than P75 for phase_3 diabetes

Geographic Reach

16 countries

91 active sites

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

3.3 years study duration

Study Start

First participant enrolled

May 1, 2007

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed

3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

December 5, 2011

Completed

Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

3.3 years

First QC Date

May 15, 2007

Results QC Date

August 5, 2011

Last Update Submit

January 30, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
At gestational week (GW) 36
Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
At gestational week (GW) 36

Secondary Outcomes (45)

Glycosylated Haemoglobin (HbA1c) During Pregnancy
During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)
Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36
At both Visit P3 (GW 24) and Visit P4 (GW 36)
Fasting Plasma Glucose (FPG)
During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]
8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24
Visit P3 (GW 24)
8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36
Visit P4 (GW 36)
+40 more secondary outcomes

Study Arms (2)

Insulin detemir

EXPERIMENTAL

Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn

Drug: insulin detemirDrug: insulin aspart

Neutral Protamine Hagedorn (NPH) insulin

ACTIVE COMPARATOR

Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn

Drug: NPH insulinDrug: insulin aspart

Interventions

insulin detemirDRUG

Treat-to-target, dose titration, s.c. (under the skin) injection

Insulin detemir

NPH insulinDRUG

Treat-to-target, dose titration, s.c. (under the skin) injection

Neutral Protamine Hagedorn (NPH) insulin

insulin aspartDRUG

Treat-to-target, dose titration, s.c. (under the skin) injection

Insulin detemirNeutral Protamine Hagedorn (NPH) insulin

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 1 diabetes treated with insulin for at least 12 months
Planning to become pregnant and have a screening HbA1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or
Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial and a HbA1c lesser than or equal to 8.0% when pregnancy is confirmed

You may not qualify if:

Known or suspected hypersensitivity to the trial product(s) or related products
Untreated hyperthyroidism or hypothyroidism
Known or suspected abuse of alcohol or narcotics
Cardiac problems
Impaired kidney function
History of severe hyperemesis gravidarum
Treatment with in-vitro fertilisation or other medical infertility treatment
Impaired liver function
Uncontrolled hypertension
Proliferative retinopathy or maculopathy requiring acute treatment
Known to be HIV (human immunodeficiency virus) positive, Hepatitis B or Hepatitis C positive
Any concomitant medication contraindicated in pregnancy

Contact the study team to confirm eligibility.