Phase 3
Completed N=274
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
Source: ClinicalTrials.gov NCT01713530 ↗Enrolled (actual)
274
Serious AEs
7.4%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in HbA1c (%) — -1.23; -1.42 percentage change in HbA1c
Summary
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (%) |
-1.23; -1.42 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-2.22; -1.90 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes |
2894; 2685; 29; 15; 1818; 1843 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes |
75; 96 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAE) |
330; 298 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
- Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
- HbA1c 7.0% - 10.0%
- Body mass index (BMI) less than or equal to 40.0 kg/m^2
Exclusion Criteria
- Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Chronic disorder or disease which might jeopardise safety or compliance
- Malignant neoplasms
- Recurrent severe hypoglycaemia
Data sourced from ClinicalTrials.gov (NCT01713530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.