Phase 3
Completed N=629
Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00982228 ↗
Enrolled (actual)
629
Serious AEs
16.0%
Results posted
Dec 2015
Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment — -0.40; -0.39 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Africa, Europe and the United States of America (USA).
The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes.
The main period is registered internally at Novo Nordisk as NN1250-3583 while the extension period is registered as NN1250-3644.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment |
-0.40; -0.39 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
383; 374; 14; 17; 22; 26 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
3750; 3743 | — |
| PRIMARY Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin |
11.3; 11.0 | — |
| SECONDARY Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
390; 532 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment |
-0.27; -0.24 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment |
8.0; 8.1 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
4254; 4018 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
441; 586 | — |
| SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 |
8.1; 8.3 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes mellitus for at least 12 months
- Current treatment with any basal bolus insulin for at least 12 months
- HbA1c below or equal to 10.0%
- BMI (Body Mass Index) below or equal to 35.0 kg/m^2
- For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3583 (NCT00982228)
Exclusion Criteria
- Use of any other antidiabetic drug than insulin within the last 3 months
- Cardiovascular disease within the last 6 months
- Uncontrolled treated/untreated severe hypertension
- Recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer
Data sourced from ClinicalTrials.gov (NCT00982228). 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.