A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country506 target enrollmentJuly 26, 2015

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsinsulin degludec/liraglutide insulin glargine insulin aspart

Drugsinsulin degludec/liraglutide insulin glargine insulin aspart

Overview

Phase: Phase 3
Intervention: insulin degludec/liraglutide
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 506
Locations: 1
Primary Endpoint: Change in HbA1c (Glycosylated Haemoglobin)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.

Registry

clinicaltrials.gov

Start Date

July 26, 2015

End Date

October 5, 2016

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

•Male or female, age at least 18 years at the time of signing informed consent
•Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
•HbA1c (glycosylated haemoglobin) 7.0-10.0% \[53mmol/mol-86mmol/mol\] (both inclusive) by central laboratory analysis
•Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
•Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
•Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
•Body mass index (BMI) below or equal to 40 kg/m\^2

Exclusion Criteria

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
•Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
•Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
•Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
•Screening calcitonin at least 50 ng/L
•History of pancreatitis (acute or chronic)
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

Arms & Interventions

IDegLira

Intervention: insulin degludec/liraglutide

IGlar plus IAsp

Intervention: insulin glargine

IGlar plus IAsp

Intervention: insulin aspart

Outcomes

Primary Outcomes

Change in HbA1c (Glycosylated Haemoglobin)

Time Frame: Week 0, Week 26

Change in HbA1c values after 26 weeks of treatment.

Secondary Outcomes

Responder for HbA1c Below or Equal to 6.5 %(After 26 weeks of treatment)
Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.(Weeks 0-26)
Change in Body Weight(Week 0, Week 26)
Responder for HbA1c Below 7.0%(After 26 weeks of treatment)