NCT01713530|CompletedPhase 3Results

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN5401-39962012-002346-20U1111-1130-7135

Study Type

interventional

Target

274

Locations

5 countries

Sites

Timeline

RegisteredOct 2012

StartedFeb 2013

CompletionJan 2014

Brief Summary

This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Trial Health

On Track

Trial Health Score

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

Enrollment

274

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Feb 2013

Shorter than P25 for phase_3 diabetes

Geographic Reach

5 countries

51 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

11 months study duration

First Submitted

Initial submission to the registry

October 22, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

February 21, 2013

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2014

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

November 17, 2015

Completed

Last Updated

April 2, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

October 22, 2012

Results QC Date

October 16, 2015

Last Update Submit

March 6, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (%)
Change from baseline in HbA1c (%) after 26 weeks of treatment
Week 0, week 26

Secondary Outcomes (5)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Number of Treatment Emergent Hypoglycaemic Episodes
During Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes
During Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Weeks 0-26
Incidence of Treatment Emergent Adverse Events (TEAE)
Weeks 0-26

Study Arms (2)

IDegAsp BID+/-OADs

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

IDeg OD plus IAsp +/-OADs

EXPERIMENTAL

Drug: insulin degludecDrug: insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.

IDegAsp BID+/-OADs

insulin degludecDRUG

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.

IDeg OD plus IAsp +/-OADs

insulin aspartDRUG

Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.

IDeg OD plus IAsp +/-OADs

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
HbA1c 7.0% - 10.0%
Body mass index (BMI) less than or equal to 40.0 kg/m\^2

You may not qualify if:

Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Chronic disorder or disease which might jeopardise safety or compliance
Malignant neoplasms
Recurrent severe hypoglycaemia

Contact the study team to confirm eligibility.