Clinical trial NCT00447382: Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Official title: A 12-months Multi-national, Multi-centre, Double Blind, Randomised, Parallel Safety and Efficacy Comparison of Insulin Detemir Produced by the Current Process and Insulin Detemir Produced by the NN729 Process in Subjects With Type 1 Diabetes on a Basal-bolus Regimen With Insulin Aspart as the Bolus Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-03-14
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Basal-bolus treatment for at least 3 months
* Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
* HbA1c (glycosylated haemoglobin) less than or equal to 12.0%

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
* Receipt of any trial drug within 1 month prior to this trial
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)

Primary outcomes:
measure: Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies
timeFrame: week 0, week 52
Secondary outcomes:
measure: Hypoglycaemic Episodes
timeFrame: Weeks 0-52
measure: Glycaemic Control Parameters (Change in HbA1c)
timeFrame: week 0, week 52
measure: Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])
timeFrame: week 0, week 52
measure: Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])
timeFrame: week 0, 26 and 52
measure: Change From Baseline in Detemir Specific Antibodies
timeFrame: Week 0, week 52
measure: Change From Baseline in Total Antibodies
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Basophilis)
timeFrame: week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Eosinophils)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Haemoglobin)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Lymphocytes)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Monocytes)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Neutrophils)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Thrombocytes)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Haematology - Leucocytes)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Albumin)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Creatinine)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Potassium)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Sodium)
timeFrame: Week 0, week 52
measure: Clinical Laboratory Values (Change in Biochemistry - Total Protein)
timeFrame: Week 0, week 52
measure: Adverse Events
timeFrame: Weeks 0-52
Other outcomes:
Locations:
city: Belgrade
country: Former Serbia and Montenegro
city: Frankfurt
country: Germany
city: Skopje
country: North Macedonia
city: Moscow
country: Russian Federation
city: Cape Town
country: South Africa
state: Western Cape
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: