The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

Novo Nordisk A/S1 site in 1 country435 target enrollmentAugust 29, 2012

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/liraglutide placebo

Drugsinsulin degludec/liraglutide placebo

Overview

Phase: Phase 3
Intervention: insulin degludec/liraglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 435
Locations: 1
Primary Endpoint: Change in Glycosylated Haemoglobin (HbA1c)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 29, 2012

End Date

October 23, 2013

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

Insulin degludec/liraglutide

Intervention: insulin degludec/liraglutide

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change in Glycosylated Haemoglobin (HbA1c)

Time Frame: Week 0, Week 26

Change in HbA1c from baseline to 26 weeks.

Secondary Outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
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 Body Weight(Week 0, week 26)
Number of Adverse Events (AEs)(After 26 weeks of treatment)
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes(After 26 weeks of treatment)