NCT01045707|CompletedPhase 3Results

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

BOOST™

NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)

Novo Nordisk A/S ClinicalTrials.gov

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5 other identifiers

NN5401-35902009-011271-78U1111-1111-71782009-015839-33U1111-1114-9237

Study Type

interventional

Target

530

Locations

9 countries

Sites

Timeline

RegisteredJan 2010

StartedJan 2010

CompletionOct 2010

Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral anti-diabetic drug). The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Trial Health

On Track

Trial Health Score

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

Enrollment

530

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

9 countries

92 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

January 1, 2010

Completed

7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed

5.1 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

December 8, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

January 8, 2010

Results QC Date

October 19, 2015

Last Update Submit

October 26, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are 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 the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the 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 hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Week 0 to Week 53 + 7 days follow up

Secondary Outcomes (2)

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Week 0, Week 53
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Week 26

Study Arms (2)

IDegAsp OD

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

IGlar OD

EXPERIMENTAL

Drug: insulin glargine

Interventions

insulin degludec/insulin aspartDRUG

Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.

IDegAsp OD

insulin glargineDRUG

Injected s.c. (under the skin) once daily. Dose was individually adjusted.

IGlar OD

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
Body Mass Index (BMI) no higher than 40.0 kg/m\^2
For EXTENSION period (NN5401-3726):
Informed consent obtained before any trial-related activities
Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

You may not qualify if:

For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

Contact the study team to confirm eligibility.