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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: insulin degludec/liraglutide
* Drug: insulin glargine
* Drug: insulin aspart


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDegLira<br> | Drug: insulin degludec/liraglutide<br>* Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.<br>|
| Active Comparator: IGlar plus IAsp<br> | Drug: insulin glargine<br>* Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.<br>Drug: insulin aspart<br>* Injected s.c./subcutaneously (under the skin) before each main meal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (Glycosylated Haemoglobin) | Change in HbA1c values after 26 weeks of treatment. | Week 0, Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes. | Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. | Weeks 0-26 | 
| Change in Body Weight | Change in body weight after 26 weeks of treatment. | Week 0, Week 26 | 
| Responder for HbA1c Below 7.0% | Number of subjects with HbA1c below 7% after 26 weeks of treatment. | After 26 weeks of treatment | 
| Responder for HbA1c Below or Equal to 6.5 % | Number of subjects with HbA1c below 6.5% after 26 weeks of treatment. | After 26 weeks of treatment |