Diabetes Mellitus, Type 2
Conditions
Brief summary
This study looks at the effect and safety of a new fast-acting insulin (NNC0471-0119) in people with type 2 diabetes when given by an insulin pump. The study tests how fast insulin NNC0471-0119 enters bloodstream, how long it stays there and how much it lowers blood sugar. The new insulin NNC0471-0119 will be compared to insulin aspart. The study will last for about 13-67 days (or a half to 2 months).
Interventions
DRUGNNC0471-0119 H
NNC0471-0119 H will be administered subcutaneously.
DRUGInsulin Aspart
Insulin aspart will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (sex at birth). * Age 18-69 years (both inclusive) at the time of signing the informed consent. * Diagnosed with Type 2 Diabetes (T2D) greater than or equal to (≥) 180 days before screening. * Treated with any injectable insulin, except once-weekly insulin, ≥ 180 days before screening. * Current daily insulin treatment between 0.2 and 1.2 Insulin units per kilogram per day \[(I) U/kg/day\] (both inclusive) with or without the following anti-diabetic drugs with stable doses ≥ 90 days prior to the day of screening: * Any metformin formulation * Dipeptidyl peptidase-4 inhibitor (DPP4i) * Sodium-glucose Cotransporter-2 inhibitor (SGLT2i) * Body mass index (BMI) between 18.5 and 34.9 kg/m2 (both inclusive) at screening. * HbA1c lesser than or equal to (≤) 9.5%
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour | 0 to 1 hour after bolus infusion | Measured in milligram per kilogram (mg/kg). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(GIR,0-t,basal-corrected): Area under the basal-corrected GIR-time curve from 0 to t | 0 to 11 hours after bolus infusion | Measured in mg/kg. |
| AUC(GIR,0-1h,basal-corrected)/AUC(GIR,0-t,basal-corrected): Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t | 0 to 11 hours after bolus infusion | Measured in percentage (%). |
| GIR (max,basal-corrected): Maximum observed basal-corrected GIR | 0 to 11 hours after bolus infusion | Measured in milligrams per (kilogram \*minute) (mg/\[kg\*min\]). |
| AUC(NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t | 0 to 11 hours after bolus infusion | Measured in %. |
| AUC(NNC0471-0119,0-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t | 0 to 11 hours after bolus infusion | Measured in hours\*picomole per liter (h\*pmol/L). |
| AUC(NNC0471-0119,0-30min,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes | 0 to 30 minutes after bolus infusion | Measured in h\*pmol/L. |
| AUC(NNC0471-0119,2h-t,basal-corrected): Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t | 2 to 11 hours after bolus infusion | Measured in h\*pmol/L. |
| AUC(NNC0471-0119,2h-t,basal-corrected)/AUC(NNC0471-0119 H,0-t,basal-corrected): Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t | 0 to 11 hours after bolus infusion | Measured in %. |
| C(max,NNC0471-0119,basal-corrected): Maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 11 hours after bolus infusion | Measured in picomoles per litre (pmol/L). |
| t(early50%Cmax,NNC0471-0119,basal-corrected): Time to early 50% maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 11 hours after bolus infusion | Measured in minutes (Min). |
| t(late50%Cmax,NNC0471-0119,basal-corrected): Time to late 50% maximum observed basal-corrected serum NNC0471-0119 concentration | 0 to 11 hours after bolus infusion | Measured in min. |
| Number of adverse events (AEs) | From start of first investigational medicinal product (IMP) basal rate infusion (day -1) until completion of post-treatment end of study visit (up to 67 days) | Measure in number of events. |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed