Phase 2
Completed N=66
Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00842361 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
Nov 2015
Primary outcomePrimary: Rate of Major and Minor Hypoglycaemic Episodes — 0; 0; 13.63; 21.83 Episodes /year of patient exposure
Summary
This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Major and Minor Hypoglycaemic Episodes |
0; 0; 13.63; 21.83 | — |
| PRIMARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
0; 0; 0.99; 2.03 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (AEs) |
13; 8; 1; 0; 0; 0 | — |
| SECONDARY Change in Body Weight |
0.09; -0.10 | — |
| SECONDARY Electrocardiogram (ECG) Worsening |
2; 0 | — |
| SECONDARY Diastolic BP (Blood Pressure) |
77.3; 75.4; 76.8; 76.7 | — |
| SECONDARY Systolic BP (Blood Pressure) |
137.5; 130.8; 137.0; 130.9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with type 2 diabetes mellitus
- Current treatment using a long-acting insulin analogue/intermediate-acting insulin preparation (except insulin glargine) or a pre-mixed insulin/insulin analogue preparation (except Mix30) on a twice daily regimen for at least 12 weeks, with stable insulin dose for the last 4 weeks (a brand of insulin preparation and dosing regimen has not been changed in the preceding 12 weeks)
- HbA1c below 10.0%
- Body Mass Index (BMI) < 30.0 kg/m^2
Exclusion Criteria
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- Current treatment with total insulin dose of more than 100 U or IU/day
- Current treatment or expected to start treatment with systemic corticosteroid
- Treatment with oral anti-diabetic drugs (OADs: including alpha-glucosidase inhibitor and insulin sensitizer [thiazolidinedione: TZD]) within the last 12 weeks prior to screening
Data sourced from ClinicalTrials.gov (NCT00842361). 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.