Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

435

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Aug 2012

Geographic Reach

8 countries

87 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

1.2 years study duration

First Submitted

Initial submission to the registry

June 11, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

August 29, 2012

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2013

Completed

3.3 years until next milestone

Results Posted

Study results publicly available

February 17, 2017

Completed

Last Updated

October 27, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

June 11, 2012

Results QC Date

December 20, 2016

Last Update Submit

September 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline to 26 weeks.
Week 0, Week 26

Secondary Outcomes (6)

Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
Week 26
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Week 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Week 0, week 26
Change From Baseline in Body Weight
Week 0, week 26
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
After 26 weeks of treatment
+1 more secondary outcomes

Study Arms (2)

Insulin degludec/liraglutide

EXPERIMENTAL

Drug: insulin degludec/liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

insulin degludec/liraglutideDRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Insulin degludec/liraglutide

placeboDRUG

Injected subcutaneously (under the skin) once daily.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects with type 2 diabetes mellitus
HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
Body Mass Index (BMI) below or equal to 40 kg/m\^2

You may not qualify if:

Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
Screening calcitonin above or equal to 50 ng/l
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures
Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product
History of chronic pancreatitis or idiopathic acute pancreatitis

Contact the study team to confirm eligibility.