Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03268005 | Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes | PHASE3 | COMPLETED | 1,264 | — | — | Sep 19, 2017 | Jan 29, 2019 | Jan 11, 2022 | 167 | United States, Argentina +16 |
| NCT02825251 | Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 472 | — | — | Jul 6, 2016 | Jul 21, 2017 | Nov 21, 2019 | 92 | United States, Belgium +7 |
| NCT02670915 | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes | PHASE3 | COMPLETED | 834 | — | — | May 4, 2016 | Mar 3, 2018 | Jun 5, 2019 | 155 | United States, Bulgaria +16 |
| NCT02500706 | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 1,108 | — | — | May 4, 2016 | Aug 16, 2017 | Jun 12, 2019 | 152 | United States, Austria +11 |
| NCT01999322 | A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes | PHASE3 | COMPLETED | 37 | — | — | Nov 19, 2013 | May 14, 2014 | Oct 31, 2017 | 2 | United States, Germany |
| NCT01850615 | Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes | PHASE3 | COMPLETED | 323 | — | — | Sep 23, 2013 | Nov 17, 2014 | Jun 12, 2019 | 58 | United States, Argentina +4 |
| NCT01819129 | Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes | PHASE3 | COMPLETED | 881 | — | — | Sep 9, 2013 | Jan 22, 2015 | Jan 30, 2019 | 144 | United States, Canada +8 |
| NCT01831765 | Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes | PHASE3 | COMPLETED | 1,290 | — | — | Aug 26, 2013 | Jun 11, 2015 | Jun 12, 2019 | 191 | United States, Belgium +7 |
| NCT03215498 | A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes | PHASE1 | COMPLETED | 58 | — | — | Jul 3, 2017 | Nov 20, 2017 | Mar 29, 2019 | 1 | Germany |
| NCT02933853 | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 61 | — | — | Oct 14, 2016 | Dec 21, 2017 | May 24, 2019 | 1 | Austria |
| NCT02568280 | Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 42 | — | — | Oct 6, 2015 | Apr 25, 2016 | Dec 11, 2018 | 1 | Austria |
| NCT02131246 | A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 33 | — | — | May 1, 2014 | Jul 1, 2014 | Jan 18, 2017 | 1 | Austria |
| NCT02089451 | A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects | PHASE1 | COMPLETED | 21 | — | — | Mar 17, 2014 | Jun 6, 2014 | Feb 17, 2017 | 1 | Germany |
| NCT02035371 | A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 Diabetes | PHASE1 | COMPLETED | 41 | — | — | Jan 13, 2014 | Jul 24, 2014 | Mar 13, 2017 | 1 | Germany |
| NCT02033239 | A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 46 | — | — | Jan 1, 2014 | Jun 1, 2014 | Jan 18, 2017 | 1 | Germany |
| NCT02003677 | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 67 | — | — | Nov 29, 2013 | Aug 14, 2014 | Dec 11, 2018 | 1 | Germany |
| NCT01992588 | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 48 | — | — | Nov 1, 2013 | Mar 1, 2014 | Nov 8, 2016 | 1 | Germany |
| NCT01934712 | A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 50 | — | — | Aug 30, 2013 | Jan 28, 2014 | Dec 11, 2018 | 1 | Japan |
| NCT01924637 | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 36 | — | — | Aug 1, 2013 | Nov 1, 2013 | Jan 18, 2017 | 1 | Austria |
| NCT01682902 | A Randomised Trial Evaluating Continuous Subcutaneous Infusion of Formulations of NN1218 and NovoLog® in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 43 | — | — | Sep 1, 2012 | Mar 1, 2013 | Jan 9, 2017 | 1 | United States |
| NCT01618188 | A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 52 | — | — | Jun 11, 2012 | Sep 7, 2012 | Dec 11, 2018 | 1 | Germany |
| NCT01469143 | A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2011 | Jan 1, 2012 | Feb 23, 2015 | 1 | Germany |
| NCT01296438 | A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1 | PHASE1 | COMPLETED | 40 | — | — | Feb 1, 2011 | Mar 1, 2011 | Feb 23, 2015 | 1 | Germany |
| NCT01121276 | A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes | PHASE1 | COMPLETED | 82 | — | — | Apr 1, 2010 | Sep 1, 2010 | Jan 18, 2017 | 1 | United States |
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.
Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).
For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Calculated based on insulin aspart measured in serum
| Arm | Type | Description |
|---|---|---|
| Faster aspart + insulin degludec with or without metformin | EXPERIMENTAL | - |
| NovoRapid/NovoLog + insulin degludec with or without metformin | ACTIVE_COMPARATOR | - |
| Faster-acting insulin aspart CSII | EXPERIMENTAL | - |
| NovoRapid® CSII | ACTIVE_COMPARATOR | - |
| Meal-time faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Meal-time NovoRapid® (insulin aspart) and insulin degludec | ACTIVE_COMPARATOR | - |
| Post-meal faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Mealtime faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| Mealtime NovoRapid® and insulin degludec | ACTIVE_COMPARATOR | - |
| Postmeal faster-acting insulin aspart and insulin degludec | EXPERIMENTAL | - |
| FIAsp | EXPERIMENTAL | The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period |
| Insulin Aspart | ACTIVE_COMPARATOR | The trial duration is approximately 13 weeks and consists of a 1-week screening period, a 2-week run-in period, a 6-week treatment period and 1 week plus a 30-day follow-up period |
| FIAsp and basal insulin + metformin | EXPERIMENTAL | Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. |
| Basal insulin + metformin | ACTIVE_COMPARATOR | Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin. |
| Faster-acting insulin aspart (FIAsp) | EXPERIMENTAL | Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. |
| Meal time FIAsp and insulin detemir | EXPERIMENTAL | - |
| Meal time insulin aspart and insulin detemir | ACTIVE_COMPARATOR | - |
| Post meal FIAsp and insulin detemir | EXPERIMENTAL | - |
| Faster aspart followed by insulin aspart | EXPERIMENTAL | Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery |
| Insulin aspart followed by faster aspart | EXPERIMENTAL | Each participant will have 2 dosing visits (faster aspart and insulin aspart), the order decided by lottery |
| Faster Aspart | EXPERIMENTAL | - |
| Faster-acting insulin aspart | EXPERIMENTAL | Each subject will be allocated to two treatments (in random sequence). |
| NovoRapid® | ACTIVE_COMPARATOR | Each subject will be allocated to two treatments (in random sequence). |
| FIAsp followed by NovoRapid® | EXPERIMENTAL | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| NovoRapid® followed by Insulin aspart | ACTIVE_COMPARATOR | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| NovoRapid® followed by FIAsp | EXPERIMENTAL | Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days |
| Formulation 1 | EXPERIMENTAL | - |
| Formulation 2 | EXPERIMENTAL | - |
| Insulin aspart (NovoLog®) | ACTIVE_COMPARATOR | - |
| Formulation A | EXPERIMENTAL | - |
| Formulation B | EXPERIMENTAL | - |
| NN1218 | EXPERIMENTAL | - |
| Treatment sequence 1 | EXPERIMENTAL | - |
| Treatment sequence 2 | ACTIVE_COMPARATOR | - |
| NN1218, formulation A | EXPERIMENTAL | - |
| NN1218, formulation B | EXPERIMENTAL | - |
| NN1218, formulation C | EXPERIMENTAL | - |
| NN1218, formulation D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Faster-acting insulin aspart | DRUG | Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Insulin aspart | DRUG | Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Insulin degludec | DRUG | Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted. |
| Metformin | DRUG | Only participants who took metformin before the study should take metformin tablets, same dose as before the study |
| basal insulin | DRUG | Administrated subcutaneously (s.c., under the skin) once daily. |
| Insulin glargine | DRUG | Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial. |
| insulin detemir | DRUG | Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily. |
Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening...