Brief Summary

This trial was conducted in Africa, Asia, Europe, North and South America. The aim of the trial was to compare efficacy and safety of insulin degludec and insulin glargine in insulin naïve subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

833

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jun 2013

Geographic Reach

7 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

12 months study duration

First Submitted

Initial submission to the registry

May 6, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed

25 days until next milestone

Study Start

First participant enrolled

June 2, 2013

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2014

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed

Last Updated

April 7, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

May 6, 2013

Results QC Date

October 16, 2015

Last Update Submit

March 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)
Change from baseline in HbA1c (%) after 26 weeks of treatment.
Week 0, week 26

Secondary Outcomes (5)

Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes
On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)
Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)
Week 0, week 26
Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)
Week 26
Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes
Week 26
Number of Treatment Emergent AEs (Adverse Events)
On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)

Study Arms (2)

Insulin Degludec

EXPERIMENTAL

Drug: Insulin Degludec

Insulin Glargine

EXPERIMENTAL

Drug: Insulin Glargine

Interventions

Insulin DegludecDRUG

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Also known as: NN1250

Insulin Degludec

Insulin GlargineDRUG

Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.

Insulin Glargine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Insulin naïve subjects (Allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitor, alfa-glucosidase-inhibitors (acarbose) with unchanged dosing for at least 3 months prior to randomisation (Visit 2) with the minimum doses stated: metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily), insulin secretagogue (sulfonylurea or glinide): minimum half of the daily maximal dose according to local labelling, DPP-IV inhibitor: minimum 100 mg daily or according to local labelling, alfa-glucosidase-inhibitors (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 40.0 kg/m\^2

You may not qualify if:

Treatment with TZDs (thiazoledinedione), or GLP-1 (glucagon-like peptide 1) receptor agonists within the last 3 months prior to Visit 1 (screening)
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO (monoamine oxidase) inhibitors
Cardiovascular disease within the last 6 months prior to Visit 1 (screening) defined as stroke; decompensated heart failure NYHA (New York Heart Association) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes mellitus, which in the Investigator's opinion could interfere with the results of the trial
Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
Known or suspected hypersensitivity to trial product(s) or related products

Contact the study team to confirm eligibility.