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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

insulin detemir

NPH insulin

insulin aspart

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin detemir

Neutral Protamine Hagedorn (NPH) insulin

Arm Description

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 Subjects who were not pregnant at 52 weeks after randomisation were withdrawn

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

Outcomes

Primary Outcome Measures

Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36

Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36

Secondary Outcome Measures

Glycosylated Haemoglobin (HbA1c) During Pregnancy

Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36

Fasting Plasma Glucose (FPG)

8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24

8-point SMPG was recorded 3 times prior to each visit, and the average value for each of the 8-time points was applied when presenting and analysing the SMPG data. Visit reallocation was made for the early termination visit and for the withdrawal visit.

8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36

Maternal Safety - Number of Subjects With Adverse Events (AEs)

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. Serious adverse event (SAE) =any undesirable serious medical event as defined in protocol.

Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events

AE=any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product. Related AE=relationship of probable or possible. SAE=any undesirable serious medical event as defined in protocol.

Maternal Safety - Hypoglycaemic Episodes

All episodes include major, minor and symptoms only. Major episode : unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L. Diurnal: Episode occurring between 06.00 - 00.00, both including.

Maternal Safety - Nocturnal Hypoglycaemic Episodes

A nocturnal episode is any episode occurring between 0.01 - 5.59, both including. It includes major, minor and symptoms only episodes. Major: unable to self-treat. Minor: able to self-treat and plasma glucose (PG) < 3.1 mmol/L. Symptoms only: able to self-treat and no PG measurement or PG glucose ≥3.1 mmol/L.

Maternal Safety - Change in Albumin Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Creatinine Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Potassium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Sodium Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Total Protein Serum Level (Biochemistry)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Haemoglobin Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Leukocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Thrombocytes Level (Haematology)

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Urine Albumin Level (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).

Maternal Safety - Change in Insulin Detemir Specific Antibodies

Change in concentrations of values for insulin detemir specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.

Maternal Safety - Change in Insulin Aspart Specific Antibodies

Change in concentrations values for insulin aspart specific antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing.

Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies

Change in concentrations values for insulin detemir/aspart cross-reacting antibodies from baseline to Visit P4 was calculated. The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing

Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).

Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)

Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).

Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood

Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit

Change in the body weight was summarised by treatment.

Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the systolic blood pressure was summarised by treatment.

Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Change in the diastolic blood pressure was summarised by treatment.

Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up

Change in the pulse was summarised by treatment.

Maternal Safety - Electrocardiogram (ECG)

The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' (at Visit 1, 3 weeks before randomisation) to 'Abnormal, clinically significant' (at Follow-Up). 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.

Maternal Safety - Acceleration of Retinopathy in Any Eye

Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.

Maternal Safety - Acceleration of Nephropathy

Acceleration of nephropathy was defined as a change from a low U-albumin:U-creatinine ratio ≤33.93 mg/mmol to a high U-albumin:U-creatinine ratio > 33.93 mg/mmol from GW 8-12 (Visit P1) to the follow-up visit.

Maternal Safety - Mode of Delivery

Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.

Pregnancy Outcome at Delivery

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Stillbirth indicates death between at or after 22 GW and at or before delivery.

Pregnancy Outcome at Follow-Up

Induced abortion means interruption of a living pregnancy < 22 completed weeks. Early foetal death means death before 22 completed GWs. Perinatal Death means death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal Death means death between at or after 7 completed days and before 28 completed days after delivery. Death During Follow-Up means death between at or after 28 days after delivery and at or before Follow-Up.

Safety - Total Daily Insulin Dose During Pregnancy

Safety - Composite Pregnancy Outcome

Wt. corresponds to weight of live-born infants. Pre-term delivery: delivery before 37 completed GWs including abortions. Early foetal death: death before 22 completed GWs. Perinatal mortality: death of a foetus/infant between ≥ 22 completed GWs and < 1 completed week after delivery. Neonatal mortality: post-partum after 7 completed days and before 28 completed days after delivery. Major-malformation: a life threatening structural anomaly or one likely to cause significant impairment of health or functional capacity and needs medical or surgical treatment.

Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Full Information

NCT ID

NCT00474045

First Posted

May 15, 2007

Last Updated

January 30, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00474045

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

470 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin detemir

Arm Type

Experimental

Arm Description

Arm Title

Neutral Protamine Hagedorn (NPH) insulin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

insulin detemir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NPH insulin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

insulin aspart

Intervention Description

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

Primary Outcome Measure Information:

Title

Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36

Time Frame

At gestational week (GW) 36

Title

Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36

Time Frame

At gestational week (GW) 36

Secondary Outcome Measure Information:

Title

Glycosylated Haemoglobin (HbA1c) During Pregnancy

Time Frame

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)

Title

Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36

Time Frame

At both Visit P3 (GW 24) and Visit P4 (GW 36)

Title

Fasting Plasma Glucose (FPG)

Time Frame

During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]

Title

8-point Self-monitored Plasma Glucose (SMPG) Profile at GW 24

Description

Time Frame

Visit P3 (GW 24)

Title

8-point Self Monitored Plasma Glucose (SMPG) Profile at GW 36

Description

Time Frame

Visit P4 (GW 36)

Title

Maternal Safety - Number of Subjects With Adverse Events (AEs)

Description

Time Frame

Participants were followed during the pregnancy period, an average of 9.6 months

Title

Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events

Description

Time Frame

Foetuses/Newborns were followed during the pregnancy period, an average of 9.6 months and Follow-Up period (6 weeks after delivery)

Title

Maternal Safety - Hypoglycaemic Episodes

Description

Time Frame

Participants were followed during the pregnancy period, an average of 9.6 months

Title

Maternal Safety - Nocturnal Hypoglycaemic Episodes

Description

Time Frame

Participants were followed during the pregnancy period, an average of 9.6 months

Title

Maternal Safety - Change in Albumin Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in albumin level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alanine aminotransferase level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in alkaline phosphatase level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Creatinine Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in creatinine serum level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in lactate dehydrogenase serum level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Potassium Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in potassium serum level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Sodium Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in sodium serum level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Total Protein Serum Level (Biochemistry)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in total protein serum level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Haemoglobin Level (Haematology)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in haemoglobin level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Leukocytes Level (Haematology)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in leukocytes level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Thrombocytes Level (Haematology)

Description

This is the standard safety lab parameter and is calculated as an estimate of the mean change from Visit P1 in thrombocytes level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Urine Albumin Level (Urinalysis)

Description

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in urine albumin level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis)

Description

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in albumin/creatinine ratio at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Urine N (Creatinine) (Urinalysis)

Description

This is the standard safety lab parameter and calculated as an estimate of the mean change from Visit P1 in Urine-N (creatinine) level at Follow-Up Visit (6 weeks after delivery).

Time Frame

Visit P1 (GW 8-12), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change in Insulin Detemir Specific Antibodies

Description

Time Frame

Baseline, Visit P4 (GW 36). Baseline is Visit 2 (randomisation visit, within 3 weeks of screening) for subjects not pregnant at randomisation and Visit P1 (GW 8-12) for pregnant subjects at randomisation.

Title

Maternal Safety - Change in Insulin Aspart Specific Antibodies

Description

Time Frame

Title

Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies

Description

Time Frame

Title

Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood

Description

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).

Time Frame

At Delivery (End of Pregnancy)

Title

Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood

Description

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T)

Time Frame

At Delivery (End of Pregnancy)

Title

Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood

Description

Antibodies were measured in a subtraction radioimmunoassay and expressed as antibody bound tracer relative to the total amount of tracer (%B/T).

Time Frame

At Delivery (End of Pregnancy)

Title

Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies

Description

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Time Frame

At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Title

Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood

Time Frame

At Delivery

Title

Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit

Description

Change in the body weight was summarised by treatment.

Time Frame

Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)

Title

Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Description

Change in the systolic blood pressure was summarised by treatment.

Time Frame

Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit

Description

Change in the diastolic blood pressure was summarised by treatment.

Time Frame

Visit P1 (GW (8-12)), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (FU) Visit (6 weeks after delivery)

Title

Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up

Description

Change in the pulse was summarised by treatment.

Time Frame

Visit P1 (GW (8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up Visit (6 weeks after delivery)

Title

Maternal Safety - Electrocardiogram (ECG)

Description

Time Frame

Follow-Up (6 weeks after delivery)

Title

Maternal Safety - Acceleration of Retinopathy in Any Eye

Description

Acceleration of Retinopathy is defined as worsening of fundoscopy/fundusphotography findings from GW 8-12 (Visit P1) to follow-up on one or both eyes.

Time Frame

From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

Title

Maternal Safety - Acceleration of Nephropathy

Description

Time Frame

From GW 8-12 (Visit P1) to Follow-Up (6 weeks after delivery)

Title

Maternal Safety - Mode of Delivery

Description

Non-Planned Caesarean Section is a procedure which takes place ≤8h prior to delivery. Planned Caesarean Section takes place >8h prior to delivery.

Time Frame

At Delivery Visit

Title

Pregnancy Outcome at Delivery

Description

Time Frame

Delivery Visit

Title

Pregnancy Outcome at Follow-Up

Description

Time Frame

Follow-Up (6 weeks after delivery)

Title

Safety - Total Daily Insulin Dose During Pregnancy

Time Frame

Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Follow-Up (6 weeks after delivery)

Title

Safety - Composite Pregnancy Outcome

Description

Time Frame

End of Pregnancy

Title

Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies

Description

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Time Frame

At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

Title

Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies

Description

Cord blood (at delivery) vs. Maternal Blood at Visit P4 (GW 36)

Time Frame

At Delivery (End of Pregnancy) and at Visit P4 (GW 36)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Buenos Aires

ZIP/Postal Code

B1704ETD

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1155ADP

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1246ABQ

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Mar del Plata

ZIP/Postal Code

B7602CBM

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Pcia de Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Salta

ZIP/Postal Code

A4406CLA

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Broadmeadow

State/Province

New South Wales

ZIP/Postal Code

2292

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Garran

ZIP/Postal Code

2605

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Wollongong

ZIP/Postal Code

2500

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Feldkirch

ZIP/Postal Code

6807

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1170

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Curitiba

State/Province

Parana

ZIP/Postal Code

80030-110

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Sao Paulo

ZIP/Postal Code

01221-900

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

ZIP/Postal Code

04022-002

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2H 2G4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

State/Province

Ontario

ZIP/Postal Code

N1R 7L6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

ZIP/Postal Code

T6G 2S2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

ZIP/Postal Code

M5S 1B2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Vancouver

ZIP/Postal Code

V6H 3N1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Winnipeg

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

København ø

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Amiens

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bondy

ZIP/Postal Code

93143

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

Novo Nordisk Investigational Site

City

MONTPELLIER cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Nimes

ZIP/Postal Code

30006

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novo Nordisk Investigational Site

City

TOULOUSE cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Valenciennes

ZIP/Postal Code

59322

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Dublin 1

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin 2

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin 8

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 7

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Trondheim

ZIP/Postal Code

NO-7030

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Tønsberg

ZIP/Postal Code

3116

Country

Norway

Facility Name

Novo Nordisk Investigational Site

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lodz

ZIP/Postal Code

93-338

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Olsztyn

ZIP/Postal Code

10-061

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Szczecin

ZIP/Postal Code

71-455

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

03-242

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-306

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

101000

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

127411

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199034

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6014

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6045

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Alcoy

ZIP/Postal Code

03803

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41014

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Blackburn

ZIP/Postal Code

BB2 3HH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Exeter

ZIP/Postal Code

EX2 5AX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Northampton

ZIP/Postal Code

NN1 5BD

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Plymouth

ZIP/Postal Code

PL6 8BQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Southampton

ZIP/Postal Code

SO16 5YA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Watford

ZIP/Postal Code

WD18 0HB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21557440

Citation

Mathiesen ER, Damm P, Jovanovic L, McCance DR, Thyregod C, Jensen AB, Hod M. Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. Diabetes Metab Res Rev. 2011 Sep;27(6):543-51. doi: 10.1002/dmrr.1213.

Results Reference

result

PubMed Identifier

22851598

Citation

Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.

Results Reference

result

PubMed Identifier

23617228

Citation

Hod M, Mathiesen ER, Jovanovic L, McCance DR, Ivanisevic M, Duran-Garcia S, Brondsted L, Nazeri A, Damm P. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med. 2014 Jan;27(1):7-13. doi: 10.3109/14767058.2013.799650. Epub 2013 Jun 5.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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

Diabetes, Diabetes Mellitus, Type 1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial