Phase 3 · Liraglutide

NCT02420262 trial results

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

Change in HbA1c (Glycosylated Haemoglobin) (Percentage of glycosylated haemoglobin), Week 0, Week 26. IDegLira: -1.48; IGlar + IAsp: -1.46.

Participants
506
Status
completed
Completed
2016-10-05
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02420262), updated at source Mar 29, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02420262 measured first

Change in HbA1c (Glycosylated Haemoglobin)Percentage of glycosylated haemoglobin · Week 0, Week 26 · least squares mean
IDegLiran=244IGlar + IAspn=245
-1.48(0.05)-1.46(0.05)
Side effects by arm

Side effects in NCT02420262

Percent of participants affected, Adverse events (AEs) were collected from the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment (26 weeks + 7 days of follow-up).. The most common events the registry lists.

EventIDegLiraIGlar + IAsp
Any serious event4.8%4%
Nasopharyngitis4.8%11.9%
Nausea11.1%1.6%
Headache5.6%7.1%
Influenza7.1%4.7%
Upper respiratory tract infection6%6.7%
Diarrhoea6.3%4%
Diabetic retinopathy3.6%5.5%
Secondary outcomes

What else it measured

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.Number of episodes · Weeks 0-26 · number
IDegLiran=252IGlar + IAspn=253
129975
Change in Body Weightkg · Week 0, Week 26 · least squares mean
IDegLiran=244IGlar + IAspn=246
-0.93(0.22)2.64(0.22)
Responder for HbA1c Below 7.0%Participants · After 26 weeks of treatment · count of participants
MeasureIDegLiran=238IGlar + IAspn=233
Yes157156
No8177
Responder for HbA1c Below or Equal to 6.5 %Participants · After 26 weeks of treatment · count of participants
MeasureIDegLiran=238IGlar + IAspn=233
Yes118104
No120129
The trial

How NCT02420262 was run

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.

  • IDegLira
  • IGlar plus IAsp
Who could join the trial

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

Published papers

Papers from NCT02420262

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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