Brief Summary

This trial is conducted in Europe, North America and the United States of America. The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Trial Health

On Track

Trial Health Score

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

Enrollment

420

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Nov 2014

Geographic Reach

9 countries

84 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

1.1 years study duration

First Submitted

Initial submission to the registry

November 19, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed

Same day until next milestone

Study Start

First participant enrolled

November 21, 2014

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2015

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

May 23, 2017

Completed

Last Updated

May 23, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

November 19, 2014

Results QC Date

December 22, 2016

Last Update Submit

April 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in HbA1c
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
Week 0, week 32

Secondary Outcomes (3)

HbA1c Below 7.0%
Week 0, week 32
HbA1c Below or Equal to 6.5%
Week 0, week 32
Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Week 0-32

Study Arms (2)

Once weekly titration

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Twice weekly titration

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Interventions

insulin degludec/liraglutideDRUG

For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Once weekly titrationTwice weekly titration

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes mellitus
Male or female equal to or above 18 years of age
HbA1c (glycosylated haemoglobin) 7.0 - 10.0% \[53 mmol/mol - 86 mmol/mol\] (both inclusive), confirmed by the central laboratory
Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
Body Mass Index (BMI) below or equal to 40 kg/m\^2

You may not qualify if:

Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
Screening calcitonin above or equal to 50 ng/L
Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
History of pancreatitis (acute or chronic)

Contact the study team to confirm eligibility.