NCT03377699|CompletedPhase 3ResultsDMCFDA Drug

Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes

EXPECT

A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-4300U1111-1191-30182017-000048-17

Study Type

interventional

Target

225

Locations

14 countries

Sites

Timeline

RegisteredDec 2017

StartedNov 2017

CompletionDec 2020

Brief Summary

The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.

Trial Health

On Track

Trial Health Score

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

Enrollment

225

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Nov 2017

Longer than P75 for phase_3 diabetes

Geographic Reach

14 countries

66 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

3.1 years study duration

First Submitted

Initial submission to the registry

November 16, 2017

Completed

6 days until next milestone

Study Start

First participant enrolled

November 22, 2017

Completed

27 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2020

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

April 27, 2022

Completed

Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

3.1 years

First QC Date

November 16, 2017

Results QC Date

December 15, 2021

Last Update Submit

January 19, 2023

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.
From GW 16 to GW 36

Secondary Outcomes (23)

Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)
From GW 16 to GW 36
Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)
From GW 16 to GW 36
Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)
From GW 16 to GW 36
Last Planned Fasting Plasma Glucose Prior to Delivery
From GW 16 to GW 36
Number of Hypoglycaemic Episodes During the Pregnancy Period
From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months)
+18 more secondary outcomes

Study Arms (2)

Insulin Degludec

EXPERIMENTAL

Insulin Degludec once daily and Insulin Aspart 2-4 times daily

Drug: Insulin degludecDrug: Insulin Aspart

Insulin Determir

ACTIVE COMPARATOR

Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily

Drug: Insulin AspartDrug: Insulin detemir

Interventions

Insulin degludecDRUG

Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months

Insulin Degludec

Insulin AspartDRUG

Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months

Insulin DegludecInsulin Determir

Insulin detemirDRUG

Injection for subcutaneous (s.c., under the skin) use, once daily or twice daily. The total trial duration for subjects will be maximum 25 months

Insulin Determir

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.