Phase 3
Completed N=456
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01074268 ↗
Enrolled (actual)
456
Serious AEs
10.4%
Results posted
Nov 2015
Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment — -0.73; -0.65 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec ([Deg]) with insulin detemir (IDet), both combined with insulin aspart.
The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment |
-0.73; -0.65 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
459; 420; 20; 17; 23; 35 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment |
-0.46; -0.47 | — |
| SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26 |
7.9; 7.8 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 |
7.8; 7.8 | — |
| SECONDARY Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment |
-2.60; -0.62 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment |
-2.19; -0.82 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
4583; 4569 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
414; 593 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
3778; 3926 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
338; 481 | — |
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%
- Body Mass Index (BMI) below or equal to 35.0 kg/m^2
- For Japan only: Minimum age is 20 years
- For the extension trial only: Completed the six-month treatment period in trial NN1250-3585 (NCT01074268)
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
- Cancer and medical history of cancer
Data sourced from ClinicalTrials.gov (NCT01074268). 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.