This trial is active, not recruiting.

Conditions diabetes, diabetes mellitus, type 2
Treatments insulin degludec/liraglutide, insulin glargine, insulin aspart
Phase phase 3
Sponsor Novo Nordisk A/S
Start date July 2015
End date October 2016
Trial size 500 participants
Trial identifier NCT02420262, 2014-003621-18, NN9068-4185, REec-2015-1682, U1111-1160-6923


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
insulin degludec/liraglutide
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
(Active Comparator)
insulin glargine
Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
insulin aspart
Injected s.c./subcutaneously (under the skin) before each main meal.

Primary Outcomes

Change in HbA1c (glycosylated haemoglobin)
time frame: Week 0, Week 26

Secondary Outcomes

Number of treatment emergent severe hypoglycaemic episodes
time frame: Weeks 0-26
Number of blood glucose confirmed symptomatic hypoglycaemic episodes
time frame: Weeks 0-26
Change in body weight
time frame: Week 0, Week 26
Responder for HbA1c below 7.0%
time frame: After 26 weeks of treatment
Responder for HbA1c below or equal to 6.5 %
time frame: After 26 weeks of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.