Phase 3
Completed N=330
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00447382 ↗
Enrolled (actual)
330
Serious AEs
8.2%
Results posted
May 2011
Primary outcomePrimary: Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies — 1.81; 1.89 ratio — p=0.649
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies |
1.81; 1.89 | 0.649 |
| SECONDARY Hypoglycaemic Episodes |
21; 21; 3215; 2996; 445; 318 | — |
| SECONDARY Glycaemic Control Parameters (Change in HbA1c) |
7.88; 7.85; -0.08; -0.11 | 0.758 |
| SECONDARY Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]) |
9.73; 9.64; 0.07; -0.02 | 0.812 |
| SECONDARY Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]) |
8.17; 8.17; 8.95; 9.03; 7.66; 7.34 | — |
| SECONDARY Change From Baseline in Detemir Specific Antibodies |
1.14; 1.06 | 0.15 |
| SECONDARY Change From Baseline in Total Antibodies |
1.55; 1.55 | 0.966 |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Basophilis) |
0.30; 0.36; 0.24; 0.33; -0.25; 0.00 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Eosinophils) |
2.50; 1.82; 2.47; 2.08; -0.25; 0.00 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Haemoglobin) |
8.85; 8.80; 8.54; 8.47; -0.30; -0.31 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Lymphocytes) |
33.80; 37.45; 28.12; 36.67; -3.25; 5.33 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Monocytes) |
3.40; 4.00; 3.59; 3.42; -2.50; 0.67 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Neutrophils) |
60.00; 56.36; 65.59; 57.50; 6.25; -6.00 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Thrombocytes) |
254.0; 267.1; 242.2; 247.2; -12.8; -18.6 | — |
| SECONDARY Clinical Laboratory Values (Change in Haematology - Leucocytes) |
6.22; 6.3; 6.24; 5.96; 0.03; -0.32 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Albumin) |
4.30; 4.27; 4.28; 4.30; -0.02; 0.02 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Alanine Aminotransferase [ALAT]) |
29.21; 25.98; 30.72; 27.81; 1.34; 1.76 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Alkaline Phosphatase [ALP]) |
75.40; 75.55; 82.35; 80.42; 6.77; 4.53 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Creatinine) |
73.1; 72.3; 72.5; 73.1; -0.5; 0.8 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Lactate Dehydrogenase [LDH]) |
161.1; 159.4; 164.9; 162.7; 3.2; 2.6 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Potassium) |
4.46; 4.37; 4.49; 4.43; 0.02; 0.06 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Sodium) |
138.9; 139.2; 140.3; 140.0; 1.4; 0.8 | — |
| SECONDARY Clinical Laboratory Values (Change in Biochemistry - Total Protein) |
7.23; 7.24; 7.13; 7.19; -0.11; -0.06 | — |
| SECONDARY Adverse Events |
25; 10; 259; 346 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00447382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.