Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Trial Health

On Track

Trial Health Score

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

Enrollment

424

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Feb 2010

Shorter than P25 for phase_3 diabetes

Geographic Reach

5 countries

46 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

January 29, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2010

Completed

4.9 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

December 20, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

January 29, 2010

Results QC Date

October 19, 2015

Last Update Submit

November 30, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, Week 26

Secondary Outcomes (4)

Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Week 26
Rate of Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Week 0 to Week 26 + 7 days follow up
Change in Body Weight
Week 0, Week 26

Study Arms (2)

IDegAsp BID

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

BIAsp 30 BID

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30

Interventions

insulin degludec/insulin aspartDRUG

Injected subcutaneously twice daily. Dose was individually adjusted.

IDegAsp BID

biphasic insulin aspart 30DRUG

Injected subcutaneously twice daily. Dose was individually adjusted.

BIAsp 30 BID

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female at least 18 years of age (at least 20 years for Japan)
Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with or without metformin for at least 3 months or subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component, OD or BID, with or without metformin, for at least 3 months
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
Body mass index (BMI) maximum 35.0 kg/m\^2

You may not qualify if:

Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8 weeks prior to Visit 1
Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor agonists within 3 months prior to Visit 1
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.