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OpenTrials
Completed

NCT Number: NCT00447382

Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Frankfurt, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

insulin detemir

Drug

NN304 injected s.c. (under the skin). Given as basal insulin.

insulin aspart

Drug

Injected s.c. (under the skin). Given as bolus insulin.

Primary outcomes

  1. Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies

    Time frame: week 0, week 52

    Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (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). The change ratio does not have any unit as it is a ratio.

Secondary outcomes

  1. Hypoglycaemic Episodes

    Time frame: Weeks 0-52

    Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Hypoglycaemic episodes occurring in the time frame between 23:00 hours (included) and 06:00 hours (excluded) were defined as nocturnal.

  2. Glycaemic Control Parameters (Change in HbA1c)

    Time frame: week 0, week 52

    HbA1c (Glycosylated haemoglobin).

  3. Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG])

    Time frame: week 0, week 52

  4. Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG])

    Time frame: week 0, 26 and 52

    • point is Before Breakfast
    • point is 120 minutes after Breakfast
    • point is Before Lunch
    • point is 120 minutes after Lunch
    • point is Before Dinner
    • point is 120 minutes after Dinner
    • point is at Bedtime
    • point is At 03:00 A.M.
    • point is Before Breakfast the Following Day

  5. Change From Baseline in Detemir Specific Antibodies

    Time frame: Week 0, week 52

    Measured change in concentrations of antibody values for insulin detemir specific antibodies and the change ratio from the baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (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). The change ratio does not have any unit as it is a ratio.

  6. Change From Baseline in Total Antibodies

    Time frame: Week 0, week 52

    Measured change in concentrations of total insulin antibodies values (the sum of insulin detemir specific and insulin detemir - human insulin cross-reacting antibodies) and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (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). The change ratio does not have any unit as it is a ratio.

  7. Clinical Laboratory Values (Change in Haematology - Basophilis)

    Time frame: week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.

    Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  8. Clinical Laboratory Values (Change in Haematology - Eosinophils)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  9. Clinical Laboratory Values (Change in Haematology - Haemoglobin)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  10. Clinical Laboratory Values (Change in Haematology - Lymphocytes)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.

    Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  11. Clinical Laboratory Values (Change in Haematology - Monocytes)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage ((Week 52 %) - (Baseline %)) per participant, averaged across all participants.

    Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  12. Clinical Laboratory Values (Change in Haematology - Neutrophils)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.

    Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  13. Clinical Laboratory Values (Change in Haematology - Thrombocytes)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  14. Clinical Laboratory Values (Change in Haematology - Leucocytes)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants.

    Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

  15. Clinical Laboratory Values (Change in Biochemistry - Albumin)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory

  16. Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT])

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

    (ALAT = alanine aminotransferase)

  17. Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP])

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory.

    (ALP = alkaline phosphatase)

  18. Clinical Laboratory Values (Change in Biochemistry - Creatinine)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory

  19. Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH])

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory (LDH = lactate dehydrogenase)

  20. Clinical Laboratory Values (Change in Biochemistry - Potassium)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory

  21. Clinical Laboratory Values (Change in Biochemistry - Sodium)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory

  22. Clinical Laboratory Values (Change in Biochemistry - Total Protein)

    Time frame: Week 0, week 52

    Change from Baseline to Week 52 is calculated from the change in percentage((Week 52 %) - (Baseline %)) per participant, averaged across all participants. Measured in serum at baseline and week 52. Serum samples were analysed at a central laboratory

  23. Adverse Events

    Time frame: Weeks 0-52

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2007
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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