Phase 3
Completed N=548
Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00978627 ↗
Enrolled (actual)
548
Serious AEs
12.2%
Results posted
Nov 2015
Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment — -0.73; -0.68 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe, Oceania, and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.
The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment |
-0.73; -0.68 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
3183; 3673 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
309; 541 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
408; 442; 24; 19; 33; 48 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
3917; 4434 | — |
| SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 |
8.0; 8.4 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment |
-0.65; -0.56 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
371; 572 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment |
-1.83; -2.40 | — |
Eligibility Criteria
Inclusion Criteria
- FOR THE MAIN TRIAL, NN5401-3594:
- Type 1 diabetes mellitus for at least 12 months
- Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months
- HbA1c 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- FOR THE EXTENSION TRIAL, NN5401-3645:
- The subject must have completed the six-month treatment period in trial NN5401-3594
Exclusion Criteria
- FOR THE MAIN TRIAL, NN5401-3594:
- Treatment with other insulin regimens than insulin in a basal bolus regimen/premix insulin regimen/self mix regimen within 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer
- FOR THE EXTENSION TRIAL, NN5401-3645:
- Anticipated significant lifestyle changes during the trial
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Data sourced from ClinicalTrials.gov (NCT00978627). 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.