NCT00842361|CompletedPhase 2Results

Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

A 6-week, Randomised, Multi-centre, Open-labelled, Parallel Group, Exploratory Trial to Investigate the Safety of SIAC Compared to Mix30 (NovoRapid®30Mix) on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S ClinicalTrials.gov

Compare

2 other identifiers

NN5401-3570JapicCTI-090712

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2009

StartedJan 2009

CompletionJun 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/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 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

5 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 11, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed

6.5 years until next milestone

Results Posted

Study results publicly available

November 20, 2015

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

February 11, 2009

Results QC Date

October 19, 2015

Last Update Submit

December 15, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Rate of Major and Minor Hypoglycaemic Episodes
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
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 and 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) Worsening
Week 0, Week 6
Diastolic BP (Blood Pressure)
Week 0, Week 6
Systolic BP (Blood Pressure)
Week 0, Week 6.

Study Arms (2)

Mix30

ACTIVE COMPARATOR

Drug: biphasic insulin aspart 30

SIAC

EXPERIMENTAL

Drug: insulin degludec/insulin aspart

Interventions

insulin degludec/insulin aspartDRUG

The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner.

SIAC

biphasic insulin aspart 30DRUG

The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner.

Mix30

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 2 diabetes mellitus
Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
HbA1c below 10.0%
Body Mass Index (BMI) \< 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
Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer \[thiazolidinedione: TZD\]) within the last 12 weeks prior to screening

Contact the study team to confirm eligibility.