Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children \[6-11 years\], adolescents \[12-17 years\] and adults \[18-64 years\]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.
Interventions
DRUGFaster aspart
An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
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
6 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 6-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening * Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm
Exclusion criteria
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily) * Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours | 0-12 hours | Calculated based on insulin aspart measured in blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes | 0-15 minutes | Calculated based on insulin aspart measured in blood. |
| AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes | 0-30 minutes | Calculated based on insulin aspart measured in blood. |
| AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour | 0-1 hour | Calculated based on insulin aspart measured in blood. |
| AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour | 0-1½ hour | Calculated based on insulin aspart measured in blood. |
| AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours | 0-2 hours | Calculated based on insulin aspart measured in blood. |
| Cmax,IAsp, maximum observed serum insulin aspart concentration | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| tmax,IAsp, time to maximum observed serum insulin aspart concentration | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ) | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp | 0-12 hours | Calculated based on insulin aspart measured in blood. |
| Number of adverse events | From screening day 1 up to the study completion day 68 | Count of events |
| Mean change in plasma glucose concentration from 0-2 hours after administration | 0-2 hours | Calculated based on glucose concentration measured in plasma. |
| Mean change in plasma glucose concentration from 0-6 hours after administration | 0-6 hours | Calculated based on glucose concentration measured in plasma. |
| Change from baseline in plasma glucose concentration 1 hour after administration | Pre-dose (0 hour), 1 hour | Calculated based on glucose concentration measured in plasma. |
| Change from baseline in plasma glucose concentration 2 hours after administration | Pre-dose (0 hour), 2 hours | Calculated based on glucose concentration measured in plasma. |
| Plasma glucose concentration 1 hour after administration | 1 hour after administration | Calculated based on glucose concentration measured in plasma. |
| Plasma glucose concentration 2 hours after administration | 2 hours after administration | Calculated based on glucose concentration measured in plasma. |
| Maximum plasma glucose excursion after administration | 0-6 hours | Calculated based on glucose concentration measured in plasma. |
| Maximum plasma glucose concentration after administration | 0-6 hours | Calculated based on glucose concentration measured in plasma. |
| Time to maximum plasma glucose concentration after administration | 0-6 hours | Calculated based on glucose concentration measured in plasma. |
| Minimum plasma glucose concentration after administration | 0-6 hours | Calculated based on glucose concentration measured in plasma. |
| Number of hypoglycaemic episodes | From screening day 1 up to the study completion day 68 | Count of hypoglycaemic episodes |
| Mean change in plasma glucose concentration from 0-1 hour after administration | 0-1 hour | Calculated based on glucose concentration measured in plasma. |
Countries
Germany
Outcome results
None listed