Brief Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

145

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Apr 2012

Typical duration for phase_3 diabetes

Geographic Reach

2 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

1.8 years study duration

Study Start

First participant enrolled

April 1, 2012

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

November 18, 2015

Completed

Last Updated

March 7, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

April 2, 2012

Results QC Date

October 16, 2015

Last Update Submit

January 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
Values for change in HbA1c after each 16 weeks of treatment periods A and B.
Week 0, week 16 of each treatment period.

Secondary Outcomes (5)

Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
Week 0, week 16 of each treatment period.
Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Week 16, week 20
Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
Week 0, week 16, week 32
Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
Week 16, week 20
Number of Adverse Events (AEs)
From baseline to the end of each 16 week treatment period.

Study Arms (2)

IDeg followed by IGlar

EXPERIMENTAL

Drug: insulin degludecDrug: insulin glargine

IGlar followed by IDeg

EXPERIMENTAL

Drug: insulin degludecDrug: insulin glargine

Interventions

insulin degludecDRUG

Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.

IDeg followed by IGlarIGlar followed by IDeg

insulin glargineDRUG

Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.

IDeg followed by IGlarIGlar followed by IDeg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

You may not qualify if:

Current treatment with insulin other than insulin glargine in vials
Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Contact the study team to confirm eligibility.