Phase 3
Completed N=1,030
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00982644 ↗Enrolled (actual)
1,030
Serious AEs
15.4%
Results posted
Nov 2015
Primary outcomePrimary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment — -1.06; -1.19 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes never treated with insulin followed by the extension trial investigating the long-term safety and tolerability in terms of comparing NN1250 with insulin glargine in subjects with type 2 diabetes.
All oral anti-diabetic drug (OAD) treatment will be discontinued when trial participant enters the main trial (NN1250-3579) with the exception of metformin and dipeptidyl peptidase-IV (DPP-IV) inhibitor treatment (only in countries where DPP-IV inhibitor treatment is approved for combination treatment together with insulin, otherwise DPP-IV inhibitor treatment is also discontinued). Subjects who consent to participate in the extension trial will continue the treatment (NN1250 or insulin glargine + oral antidiabetic drugs (OADs)) to which they were randomly allocated in the 52 week main trial.
The main period is registered internally at Novo Nordisk as NN1250-3579 while the extension period is registered as NN1250-3643.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment |
-1.06; -1.19 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
172; 205 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
27; 46 | — |
| PRIMARY Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs) |
362; 339; 15; 17; 14; 17 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes |
152; 185 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment |
-0.95; -1.11 | — |
| SECONDARY Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52 |
7.7; 7.7 | — |
| SECONDARY Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 |
7.6; 7.6 | — |
| SECONDARY Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
25; 39 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Treatment with oral antidiabetic drugs (OADs) for at least three months before trial start at an unchanged dose
- HbA1c: 7.0-10.0%
- Body Mass Index (BMI) no higher than 40.0 kg/m^2
- For the extension trial only: Completion of the 52 week treatment period in trial NN1250-3579 (NCT00982644)
Exclusion Criteria
- Treatment with exenatide or liraglutide within the last 3 months before trial start
- 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
- Cancer and medical history of cancer
Data sourced from ClinicalTrials.gov (NCT00982644). 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.