DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 36

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

Secondary outcome:

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 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017