Phase 2
Completed N=65
Comparison of NN1250 Versus Insulin Detemir, Both Combined With Insulin Aspart in Subjects With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00841087 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Rate of Major and Minor Hypoglycaemic Episodes — 0; 0; 62.97; 80.84 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 or intermediate-acting insulin to insulin degludec (NN1250, SIBA) on a basal-bolus regimen in subjects with type 1 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Major and Minor Hypoglycaemic Episodes |
0; 0; 62.97; 80.84 | — |
| PRIMARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
0; 0; 4.97; 15.83 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (AEs) |
13; 15; 0; 0; 0; 0 | — |
| SECONDARY Change in Body Weight |
0.22; -0.20 | — |
| SECONDARY Electrocardiogram (ECG) |
0; 0 | — |
| SECONDARY Diastolic Blood Pressure (BP) |
73.9; 73.8; 74.7; 73.0 | — |
| SECONDARY Systolic Blood Pressure (BP) |
125.0; 125.3; 125.5; 120.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with type 1 diabetes mellitus more than one year
- Current treatment: basal (once daily at bedtime) - bolus (three times a day just before main meals) regimen only for at least 12 weeks using a long-acting insulin analogue excluding insulin detemir or intermediate-acting insulin as a basal insulin and NovoRapid® as bolus insulin (a brand of basal insulin preparation has not been changed in the preceding 12 weeks)
- HbA1c below 10.0%
- Body Mass Index (BMI) below 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
Data sourced from ClinicalTrials.gov (NCT00841087). 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.