Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
insulin detemir · 38 trials · 4 indications
Estimated amount of bound antibodies in percent of total antibodies. The primary analysis of cross-reacting antibodies included results from blood samples taken before insulin detemir and less than 3 hours after insulin aspart injection. In addition, an analysis was done including results from samples taken before insulin detemir and less than 2.5 hours after insulin aspart injection.
Measured change in concentrations of insulin detemir cross-reacting antibodies and the change ratio from baseline to end of trial was calculated. The unit for measuring antibody levels is %B/T (amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture). The change ratio does not have any unit as it is a ratio.
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
| Arm | Type | Description |
|---|---|---|
| Comb | EXPERIMENTAL | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment |
| Sita | ACTIVE_COMPARATOR | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment |
| insulin detemir | EXPERIMENTAL | Insulin detemir up to twice daily plus insulin aspart at larger meals, doses are adjusted individually (treatment up to 104 weeks) |
| Neutral Protamine Hagedorn (NPH) insulin | ACTIVE_COMPARATOR | Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn |
| NN304 | ACTIVE_COMPARATOR | Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks |
| NN729 | EXPERIMENTAL | Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks |
| NPH insulin | EXPERIMENTAL | NPH insulin + insulin aspart |
| Basal/bolus regimen 1 | EXPERIMENTAL | - |
| Basal/bolus regimen 2 | ACTIVE_COMPARATOR | - |
| Detemir | EXPERIMENTAL | - |
| NPH | ACTIVE_COMPARATOR | - |
| IDet 0.2 U/kg | EXPERIMENTAL | - |
| IDet 0.4 U/kg | EXPERIMENTAL | - |
| IDet 0.8 U/kg | EXPERIMENTAL | - |
| Treatment period 1 | EXPERIMENTAL | - |
| Treatment period 2 | ACTIVE_COMPARATOR | - |
| Glycerol | EXPERIMENTAL | - |
| Mannitol | ACTIVE_COMPARATOR | - |
| Insulin glargine | ACTIVE_COMPARATOR | - |
| insulin NPH | ACTIVE_COMPARATOR | - |
| Insulin detemir 60 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Insulin detemir 120 pmol/kg/min | EXPERIMENTAL | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Human insulin 6 pmol/kg/min | ACTIVE_COMPARATOR | Subjects will be randomised to one of six treatment sequences (the 3 test drugs given at 3 different trial days 7-28 days apart in randomised order) |
| Name | Type | Description |
|---|---|---|
| insulin detemir | DRUG | The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial. |
| sitagliptin | DRUG | The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily. |
| metformin | DRUG | Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial. |
| sulphonylurea | DRUG | Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator. |
| insulin aspart | DRUG | Treat-to target dose titration scheme (individually adjusted), injection s.c. (under the skin), at larger meals. |
| NPH insulin | DRUG | Treat-to-target, dose titration, s.c. (under the skin) injection |
| insulin NPH | DRUG | s.c. injection, once or twice daily. |
| insulin glargine | DRUG | - |
| biphasic insulin aspart | DEVICE | - |
| human soluble insulin | DRUG | Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals |
Inclusion Criteria: * Diagnosed with type 2 diabetes for at least 6 months before trial start * Treatment with at least 1000 mg metformin per day for at least 3 months * Insulin-naive (short-term insulin treatment of up to 14 days is allowed) * DPP-4 (dipeptidyl peptidase-4) inhibitor naive * HbA1c...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |