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

Novo Nordisk A/S470 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

470

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

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

NPH insulinDRUG

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

insulin aspartDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (98)

Outcomes

Primary Outcomes

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

Time frame: At gestational week (GW) 36

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

Time frame: At gestational week (GW) 36

Secondary Outcomes

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)

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)

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)]

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.

Time frame: Visit P3 (GW 24)

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

Time frame: Visit P4 (GW 36)

Data from ClinicalTrials.gov

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Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Mar del Plata, Argentina

Novo Nordisk Investigational Site

Pcia de Cordoba, Argentina

Novo Nordisk Investigational Site

Salta, Argentina

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Novo Nordisk Investigational Site

Camperdown, New South Wales, Australia

Novo Nordisk Investigational Site

St Leonards, New South Wales, Australia

...and 88 more locations

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.

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

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.

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

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.

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

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.

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

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).