Brief Summary

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,446

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach

16 countries

93 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

6 years study duration

First Submitted

Initial submission to the registry

June 27, 2013

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 4, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

September 30, 2013

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed

Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

June 27, 2013

Last Update Submit

November 18, 2019

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death
Assessed up to 4 weeks after delivery

Secondary Outcomes (9)

Incidence of major hypoglycaemia
During pregnancy
Proportion of pregnancies complicated by pre-eclampsia
During pregnancy
Proportion of pregnancies resulting in perinatal death
Assessed 1 week after delivery
Proportion of pregnancies resulting in neonatal death
Assessed 4 weeks after delivery
Proportion of pregnancies resulting in spontaneous abortion
Assessed at pregnancy termination
+4 more secondary outcomes

Study Arms (1)

All patients

Drug: insulin detemirDrug: other injectable antidiabetic treatment regimens

Interventions

insulin detemirDRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician

All patients

other injectable antidiabetic treatment regimensDRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician

All patients

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Women with diabetes mellitus, who are pregnant and treated with Levemir® or other injectable antidiabetic treatment regimens, and who have not changed basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception will be included in the Diabetes Pregnancy Registry.

Contact the study team to confirm eligibility.