NCT00978627|CompletedPhase 3Results

Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

BOOST™

NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

Novo Nordisk A/S ClinicalTrials.gov

Compare

5 other identifiers

NN5401-35942008-005769-71U1111-1111-89432009-013412-13U1111-1113-2475

Study Type

interventional

Target

548

Locations

10 countries

Sites

Timeline

RegisteredSep 2009

StartedAug 2009

CompletionMay 2010

Brief Summary

This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Trial Health

On Track

Trial Health Score

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

Enrollment

548

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Aug 2009

Shorter than P25 for phase_3 diabetes

Geographic Reach

10 countries

81 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

9 months study duration

Study Start

First participant enrolled

August 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed

5.6 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

March 20, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

September 16, 2009

Results QC Date

October 19, 2015

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (4)

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment
Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol /L.
Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. 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 53 + 7 days of follow up

Secondary Outcomes (5)

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Week 26
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Week 0, Week 53
Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment
Week 0, Week 53

Study Arms (2)

IDegAsp OD

EXPERIMENTAL

Drug: insulin degludec/insulin aspartDrug: insulin aspart

IDet

ACTIVE COMPARATOR

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Injected subcutaneously (under the skin) once daily with a meal. Dose was individually adjusted.

IDegAsp OD

insulin detemirDRUG

Injected subcutaneously (under the skin) once daily or twice daily. Dose was individually adjusted.

IDet

insulin aspartDRUG

Injected subcutaneously (under the skin) at the remaining meals. Dose was individually adjusted.

IDegAsp OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

FOR THE MAIN TRIAL, NN5401-3594:
Type 1 diabetes mellitus for at least 12 months
Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
HbA1c 7.0-10.0% (both inclusive)
BMI (Body Mass Index) below or equal to 35.0 kg/m\^2
FOR THE EXTENSION TRIAL, NN5401-3645:
The subject must have completed the six-month treatment period in trial NN5401-3594

You may not qualify if:

FOR THE MAIN TRIAL, NN5401-3594:
Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
Cardiovascular disease within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer
FOR THE EXTENSION TRIAL, NN5401-3645:
Anticipated significant lifestyle changes during the trial
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures

Contact the study team to confirm eligibility.