Phase 3
Completed N=146
Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00623194 ↗
Enrolled (actual)
146
Serious AEs
8.2%
Results posted
Jan 2011
Primary outcomePrimary: Insulin Detemir-insulin Aspart Cross-reacting Antibodies — 31.11; 43.99; 35.96; 31.22 Percent bound of total
Summary
This trial is conducted in Europe. The aim of this research is to assess the safety of continuous treatment with insulin detemir following participation in trial NN304-1689 (NCT00435019) on antibody development.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Detemir-insulin Aspart Cross-reacting Antibodies |
31.11; 43.99; 35.96; 31.22; 44.09; 35.92 | — |
| SECONDARY Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies |
2.81; 4.40; 3.05; 1.32; 2.79; 1.99 | — |
| SECONDARY Glycosylated Haemoglobin A1c (HbA1c) |
8.74 | — |
| SECONDARY Fasting Plasma Glucose Values |
7.71 | — |
| SECONDARY Hypoglycaemic Episodes |
10530; 450; 7; 5080; 7; 9080 | — |
| SECONDARY BMI (Body Mass Index) |
18.88 | — |
| SECONDARY SD-score (Z-score) for Body Weight |
0.13 | — |
| SECONDARY Diabetic Ketoacidosis |
3 | — |
| SECONDARY Insulin Dose |
0.66; 0.51 | — |
| SECONDARY Laboratory Values: Albumin Serum and Total Protein Serum (g/dL) |
4.32; 7.09 | — |
| SECONDARY Laboratory Values: Creatine Serum Umol/L |
51.08 | — |
| SECONDARY Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L) |
141.6; 4.38; 8.28 | — |
| SECONDARY Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L) |
226.7; 19.0; 199.6 | — |
| SECONDARY Laboratory Values: Leukocytes and Thrombocytes |
6.72; 301.90 | — |
| SECONDARY Fundoscopy/Fundus Photography |
1; 8; 131; 6; 1 | — |
| SECONDARY Vital Signs: Blood Pressure |
109.5; 66.6 | — |
| SECONDARY Vital Signs: Pulse |
82.6 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the subject must sign and date the Informed Consent Form.
- Finalised 52 weeks of treatment with insulin detemir in trial NN304-1689.
- Fertile females (girls who have had their first menstrual period) must use adequate contraception (barrier methods, contraceptive pills or intrauterine device (IUD)) if there is any risk of pregnancy in the opinion of the Investigator. For Denmark and France only contraceptive pills or intrauterine device are considered as adequate contraceptive methods.
Exclusion Criteria
- Significant concomitant disease such as endocrine, hepatic, renal, cardiac, respiratory, neurological, gastrointestinal, malignant or pancreatic diseases as judged by the Investigator.
- Pregnant or the intention of becoming pregnant.
- Previous participation in this trial (defined as enrolment).
Data sourced from ClinicalTrials.gov (NCT00623194). 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.