NCT00841087|CompletedPhase 2Results

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN1250-3569JapicCTI-090711

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2009

StartedJan 2009

CompletionMay 2009

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline

Completed

Started Jan 2009

Shorter than P25 for phase_2 diabetes

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

January 1, 2009

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed

6.5 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed

Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

February 10, 2009

Results QC Date

October 16, 2015

Last Update Submit

January 19, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

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
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

Secondary Outcomes (5)

Number of Treatment Emergent Adverse Events (AEs)
Week 0 to Week 6 + 5 days follow up
Change in Body Weight
Week 0, Week 6
Electrocardiogram (ECG)
Week 0, Week 6
Diastolic Blood Pressure (BP)
Week 0, Week 6
Systolic Blood Pressure (BP)
Week 0, Week 6

Study Arms (2)

SIBA

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

Insulin Detemir

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin degludecDRUG

The insulin NN1250 (insulin degludec) injected subcutaneously at bedtime

SIBA

insulin detemirDRUG

Injection subcutaneously at bedtime

Insulin Detemir

insulin aspartDRUG

Injection subcutaneously immediately before each meal.

Insulin DetemirSIBA

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.