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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002014-31 | Registry Identifier | European Medicines Agency (EudraCT) | |
| U1111-1197-0428 | Other Identifier | World Health Organization (WHO) |
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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Faster aspart followed by insulin aspart (NovoRapid®) | Experimental | Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. |
|
| Insulin aspart (NovoRapid®) followed by faster aspart | Experimental | Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faster aspart | Drug | An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes | Calculated based on insulin aspart measured in blood. | 0-15 minutes |
| AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Hanover | 30173 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Insulin aspart (NovoRapid®) | Drug | An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal. |
|
Calculated based on insulin aspart measured in blood. |
| 0-30 minutes |
| AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour | Calculated based on insulin aspart measured in blood. | 0-1 hour |
| AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour | Calculated based on insulin aspart measured in blood. | 0-1½ hour |
| AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours | Calculated based on insulin aspart measured in blood. | 0-2 hours |
| Cmax,IAsp, maximum observed serum insulin aspart concentration | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| tmax,IAsp, time to maximum observed serum insulin aspart concentration | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| 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) | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| 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 | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp | Calculated based on insulin aspart measured in blood. | 0-12 hours |
| Mean change in plasma glucose concentration from 0-1 hour after administration | Calculated based on glucose concentration measured in plasma. | 0-1 hour |
| Mean change in plasma glucose concentration from 0-2 hours after administration | Calculated based on glucose concentration measured in plasma. | 0-2 hours |
| Mean change in plasma glucose concentration from 0-6 hours after administration | Calculated based on glucose concentration measured in plasma. | 0-6 hours |
| Change from baseline in plasma glucose concentration 1 hour after administration | Calculated based on glucose concentration measured in plasma. | Pre-dose (0 hour), 1 hour |
| Change from baseline in plasma glucose concentration 2 hours after administration | Calculated based on glucose concentration measured in plasma. | Pre-dose (0 hour), 2 hours |
| Plasma glucose concentration 1 hour after administration | Calculated based on glucose concentration measured in plasma. | 1 hour after administration |
| Plasma glucose concentration 2 hours after administration | Calculated based on glucose concentration measured in plasma. | 2 hours after administration |
| Maximum plasma glucose excursion after administration | Calculated based on glucose concentration measured in plasma. | 0-6 hours |
| Maximum plasma glucose concentration after administration | Calculated based on glucose concentration measured in plasma. | 0-6 hours |
| Time to maximum plasma glucose concentration after administration | Calculated based on glucose concentration measured in plasma. | 0-6 hours |
| Minimum plasma glucose concentration after administration | Calculated based on glucose concentration measured in plasma. | 0-6 hours |
| Number of adverse events | Count of events | From screening day 1 up to the study completion day 68 |
| Number of hypoglycaemic episodes | Count of hypoglycaemic episodes | From screening day 1 up to the study completion day 68 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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