Phase 3
Completed N=447
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01009580 ↗Enrolled (actual)
447
Serious AEs
12.3%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.28; -1.30 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia, Europe and Oceania. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with biphasic insulin aspart 30 in subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.28; -1.30 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
7.0; 7.3 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
972; 1396 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
74; 253 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Subjects on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, once daily (OD) or twice daily (BID), with or without oral antidiabetic drugs) (OADs) (metformin, sulphonylurea (SU), glinides, alpha-glucosidase inhibitor, DPP-4 (dipeptidyl peptidase-4) inhibitor and pioglitazone), for at least 3 months before Visit 1
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
Exclusion Criteria
- Treatment with other insulin regimens than those listed in key inclusion criterion no. 2 within 3 months
- Treatment with rosiglitazone or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
- Cardiovascular disease within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer
Data sourced from ClinicalTrials.gov (NCT01009580). 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.