Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIBA Once Daily + NovoRapid® Compared to Insulin Detemir Once Daily + NovoRapid®, All in a Basal-bolus Regimen in Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841087
• Other study ID #: NN1250-3569
• Secondary ID: JapicCTI-090711
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2009
• Last updated: October 16, 2015
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: October 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjects with type 1 diabetes mellitus more than one year

• Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)

• HbA1c below 10.0%

• Body Mass Index (BMI) below 30.0 kg/m^2

Exclusion Criteria:

• Known hypoglycaemia unawareness or recurrent major hypoglycaemia

• Current treatment with total insulin dose of more than 100 U or IU/day

• Current treatment or expected to start treatment with systemic corticosteroid

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime
• insulin detemir
Injection subcutaneously at bedtime
• insulin aspart
Injection subcutaneously immediately before each meal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major and Minor Hypoglycaemic Episodes	Observed rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose = 55 mg/dL.	Week 0 to Week 6 + 5 days follow up	No
Primary	Rate of Nocturnal Major and Minor Hypoglycaemic Episodes	Observed rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose = 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00-05:59 (both inclusive).	Week 0 to Week 6 + 5 days follow up	No
Secondary	Number of Treatment Emergent Adverse Events (AEs)	Corresponds to number of adverse events. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.	Week 0 to Week 6 + 5 days follow up	No
Secondary	Change in Body Weight	Observed change from baseline in body weight after 6 weeks of treatment	Week 0, Week 6	No
Secondary	Electrocardiogram (ECG)	The number of subjects having a electrocardiogram (ECG) that changed from 'Normal' or 'Abnormal, not clinically significant' to 'Abnormal, clinically significant'. 'Abnormal, Clinically significant' is an abnormality that suggests a disease and/or organ toxicity and is of a severity, which requires active management.	Week 0, Week 6	No
Secondary	Diastolic Blood Pressure (BP)	Mean values at baseline (Week 0) and at Week 6	Week 0, Week 6	No
Secondary	Systolic Blood Pressure (BP)	Mean values at baseline (Week 0) and at Week 6	Week 0, Week 6	No

External Links

•   Clinical Trials at Novo Nordisk