Safety Follow-up on Children and Adolescents With Type 1 Diabetes Treated With Insulin Detemir. An Extension to Trial NN304-1689

Diabetes Clinical Trial

Official title:

A 52-Week, Multinational, Multi-Centre, Open-Labelled Extension Trial of Insulin Detemir in Children and Adolescents 3-17 Years With Type 1 Diabetes on a Basal-Bolus Regimen With Insulin Aspart as Bolus Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623194
• Other study ID #: NN304-1690
• Secondary ID: 2006-002478-23
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: November 20, 2014
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyHungary: National Institute of PharmacyRussia: Federal Service for control in Health and Social developmentUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBulgaria: Bulgarian Drug AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of HealthPoland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical TrialsTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir
Treat-to-target dose titration scheme (individually adjusted), injection s.c. (under the skin), once or twice daily.
• insulin aspart
Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Denmark,  Finland,  Hungary,  Macedonia, The Former Yugoslav Republic of,  Poland,  Russian Federation,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Detemir-insulin Aspart Cross-reacting Antibodies	Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.	week 0, 52 and 104	Yes
Secondary	Development of Insulin Detemir Specific Antibodies and Insulin Aspart Specific Antibodies	Amount of Insulin Detemir and Insulin Aspart specific antibodies in percent of total antibodies after 0, 52 and 104 weeks.	At 0, 52 and 104 weeks	Yes
Secondary	Glycosylated Haemoglobin A1c (HbA1c)	Glycosylated Haemoglobin A1c (HbA1c) measured after 104 weeks.	At 104 weeks	No
Secondary	Fasting Plasma Glucose Values	FPG (Fasting Plasma Glucose) values after 104 weeks.	At 104 weeks	No
Secondary	Hypoglycaemic Episodes	Mild: signs/symptoms but able to treat him/herself. Moderate: signs/symptoms not able to treat him/herself. Responds to oral treatment.; Severe: signs/symptoms and unable to treat him/herself. semiconscious/unconscious/in coma +/- convulsion and may require parenteral treatment.	Weeks 0-104	Yes
Secondary	BMI (Body Mass Index)	BMI (Body Mass Index) after 104 weeks.	At 104 weeks	Yes
Secondary	SD-score (Z-score) for Body Weight	Standard deviation-score (SD-score) after 104 weeks. The SD-score for weight was calculated based on a British reference population from 1990. To estimate the growth of children, standardised mean weight values were calculated for each month of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2.	At 104 weeks	Yes
Secondary	Diabetic Ketoacidosis	Diabetic ketoacidosis requiring hospitalisation	At 104 weeks	Yes
Secondary	Insulin Dose	Daily insulin doses (basal (Insulin Detemir) and bolus (Insulin Aspart)) at week 104.	At 104 weeks	No
Secondary	Laboratory Values: Albumin Serum and Total Protein Serum (g/dL)	Albumin Serum and Total Protein Serum after 104 weeks.	At 104 weeks	Yes
Secondary	Laboratory Values: Creatine Serum Umol/L	Creatine serum after 104 weeks.	At 104 weeks	Yes
Secondary	Laboratory Values: Sodium Serum, Potassium Serum and Haemoglobin (mmol/L)	Sodium Serum, Potassium Serum and Haemoglobin after 104 weeks.	At 104 weeks	Yes
Secondary	Laboratory Values: Alkaline Phosphatase Serum, Alanine Aminotransferase Serum and Lactate Dehydrogenase Serum (U/L)	Alkaline phosphatase serum, Alanine Aminotransferase serum and Lactate Dehydrogenase serum after 104 weeks.	At 104 weeks	Yes
Secondary	Laboratory Values: Leukocytes and Thrombocytes	Leukocytes and Thrombocytes after 104 weeks.	At 104 weeks	Yes
Secondary	Fundoscopy/Fundus Photography	Fundoscopy after 104 weeks. Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant; Abn. CS = Abnormal, clinically significant Abn. NCS = Abnormal, Not clinically significant	at 52 weeks and at 104 weeks	Yes
Secondary	Vital Signs: Blood Pressure	Blood pressure (Systolic and Diastolic) after 104 weeks.	At 104 weeks	Yes
Secondary	Vital Signs: Pulse	Pulse at week 104	At 104 weeks	Yes

External Links

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