Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 1
Intervention: insulin detemir (Drug); NPH insulin (Drug); insulin aspart (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
Secondary outcome: Glycosylated Haemoglobin (HbA1c) During PregnancySubjects 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 Self Monitored Plasma Glucose (SMPG) Profile at GW 36 Maternal Safety - Number of Subjects With Adverse Events (AEs) Safety in Children - Number of Subjects (Foetuses and Newborns) With Adverse Events Maternal Safety - Hypoglycaemic Episodes Maternal Safety - Nocturnal Hypoglycaemic Episodes Maternal Safety - Change in Albumin Serum Level (Biochemistry) Maternal Safety - Change in Alanine Aminotransferase Serum Level (Biochemistry) Maternal Safety - Change in Alkaline Phosphatase Serum Level (Biochemistry) Maternal Safety - Change in Creatinine Serum Level (Biochemistry) Maternal Safety - Change in Lactate Dehydrogenase Serum Level (Biochemistry) Maternal Safety - Change in Potassium Serum Level (Biochemistry) Maternal Safety - Change in Sodium Serum Level (Biochemistry) Maternal Safety - Change in Total Protein Serum Level (Biochemistry) Maternal Safety - Change in Haemoglobin Level (Haematology) Maternal Safety - Change in Leukocytes Level (Haematology) Maternal Safety - Change in Thrombocytes Level (Haematology) Maternal Safety - Change in Urine Albumin Level (Urinalysis) Maternal Safety - Change in Albumin/Creatinine Ratio (Urinalysis) Maternal Safety - Change in Urine N (Creatinine) (Urinalysis) Maternal Safety - Change in Insulin Detemir Specific Antibodies Maternal Safety - Change in Insulin Aspart Specific Antibodies Maternal Safety - Change in Insulin Detemir/Insulin Aspart Cross Reacting Antibodies Pregnancy Outcome Safety - Level of Detemir Specific Antibodies (AB) in Umbilical Cord Blood Pregnancy Outcome Safety - Level of Aspart Specific Antibodies (AB) in Umbilical Cord Blood Pregnancy Outcome Safety - Level of Cross-Reacting Antibodies (AB) in Umbilical Cord Blood Ratio Between Detemir Specific Antibodies in Cord Blood and Maternal Antibodies Pregnancy Outcome Safety - Level of Insulin Detemir in Umbilical Cord Blood Maternal Safety - Change From Visit P1 in Body Weight During Pregnancy by Visit Maternal Safety - Change From Visit P1 in Systolic Blood Pressure During Pregnancy and at Follow-Up by Visit Maternal Safety - Change From Visit P1 in Diastolic Blood Pressure During Pregnancy and at Follow-Up by Visit Maternal Safety - Change From Visit P1 in Pulse During Pregnancy and at Follow-Up Maternal Safety - Electrocardiogram (ECG) Maternal Safety - Acceleration of Retinopathy in Any Eye Maternal Safety - Acceleration of Nephropathy Maternal Safety - Mode of Delivery Pregnancy Outcome at Delivery Pregnancy Outcome at Follow-Up Safety - Total Daily Insulin Dose During Pregnancy Safety - Composite Pregnancy Outcome Ratio Between Aspart Specific Antibodies in Cord Blood and Maternal Antibodies Ratio Between Cross-reacting Antibodies in Cord Blood and Maternal Antibodies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Buenos Aires C1181ACH, Argentina
Garran 2605, Australia
Wien 1090, Austria
São Paulo 04022-002, Brazil
Toronto M5G 1X5, Canada
Zagreb 10 000, Croatia
København ø 2100, Denmark
Helsinki 00029, Finland
Lille 59037, France
Dublin 8, Ireland
Petach Tikva 49100, Israel
Bergen 5021, Norway
Lodz 93-338, Poland
Moscow 127644, Russian Federation
Santander 39008, Spain
Bristol BS10 5NB, United Kingdom
Durban, KwaZulu-Natal 4001, South Africa
Additional Information
Clinical Trials at Novo Nordisk
Starting date: May 2007
Last updated: August 12, 2014
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