What NCT02420262 measured first
| IDegLiran=244 | IGlar + IAspn=245 |
|---|---|
| -1.48(0.05) | -1.46(0.05) |
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.
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.
| IDegLiran=244 | IGlar + IAspn=245 |
|---|---|
| -1.48(0.05) | -1.46(0.05) |
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.
| Event | IDegLira | IGlar + IAsp |
|---|---|---|
| Any serious event | 4.8% | 4% |
| Nasopharyngitis | 4.8% | 11.9% |
| Nausea | 11.1% | 1.6% |
| Headache | 5.6% | 7.1% |
| Influenza | 7.1% | 4.7% |
| Upper respiratory tract infection | 6% | 6.7% |
| Diarrhoea | 6.3% | 4% |
| Diabetic retinopathy | 3.6% | 5.5% |
| IDegLiran=252 | IGlar + IAspn=253 |
|---|---|
| 129 | 975 |
| IDegLiran=244 | IGlar + IAspn=246 |
|---|---|
| -0.93(0.22) | 2.64(0.22) |
| Measure | IDegLiran=238 | IGlar + IAspn=233 |
|---|---|---|
| Yes | 157 | 156 |
| No | 81 | 77 |
| Measure | IDegLiran=238 | IGlar + IAspn=233 |
|---|---|---|
| Yes | 118 | 104 |
| No | 120 | 129 |
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.
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.