Brief Summary

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,609

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Mar 2017

Typical duration for phase_3 diabetes

Geographic Reach

12 countries

229 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

2 years study duration

First Submitted

Initial submission to the registry

March 10, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed

Same day until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed

19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed

1 year until next milestone

Results Posted

Study results publicly available

March 12, 2020

Completed

Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.9 years

First QC Date

March 10, 2017

Results QC Date

January 28, 2020

Last Update Submit

January 6, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.
36 Weeks

Secondary Outcomes (15)

Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)
88 weeks
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
36 weeks
Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)
36 weeks (maintenance 2)
Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)
Week 0, week 88
Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)
Week 0, week 88
+10 more secondary outcomes

Study Arms (2)

IDeg 200 U/mL

EXPERIMENTAL

Drug: Insulin degludec

IGlar 300 U/mL

ACTIVE COMPARATOR

Drug: Insulin glargine

Interventions

Insulin degludecDRUG

For subcutaneous (s.c., under the skin) injection once daily

IDeg 200 U/mL

Insulin glargineDRUG

For subcutaneous (s.c., under the skin) injection once daily

IGlar 300 U/mL

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.