Brief Summary

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

458

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jun 2013

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

40 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

10 months study duration

Study Start

First participant enrolled

June 1, 2013

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed

2 years until next milestone

Results Posted

Study results publicly available

March 17, 2016

Completed

Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

10 months

First QC Date

June 14, 2013

Results QC Date

October 16, 2015

Last Update Submit

December 19, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)
Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)
Week 0, week 26

Secondary Outcomes (8)

Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial
After 26 weeks of treatment
Incidence of Treatment Emergent Adverse Events (TEAEs)
Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))
Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition
Weeks 0-26
+3 more secondary outcomes

Study Arms (4)

IDeg OD Flexible Dose

EXPERIMENTAL

Drug: insulin degludec

IDeg OD Fixed Dose

EXPERIMENTAL

Drug: insulin degludec

IDeg OD Simple

EXPERIMENTAL

Drug: insulin degludec

IDeg OD Stepwise

EXPERIMENTAL

Drug: insulin degludec

Interventions

insulin degludecDRUG

Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.

IDeg OD Fixed DoseIDeg OD Flexible DoseIDeg OD SimpleIDeg OD Stepwise

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
Body mass index (BMI) equal to or below 35 kg/m\^2

You may not qualify if:

Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
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; all within the last 26 weeks prior to Visit 1 (Screening visit)
Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)

Contact the study team to confirm eligibility.