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Completed

NCT Number: NCT05262595

A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump

This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.

The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.

The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).

Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.

Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.

The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.

During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.

Women: Women cannot take part if they are of childbearing potential.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
  • Aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with T1DM for more than1 year prior to the day of screening.
  • Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
  • Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.

Exclusion criteria

  • Known or suspected hypersensitivity to study interventions or related products.
  • Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.

Treatment and study plan

NNC0471-0119 A

Drug

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.

The study will last 1-4 months

NNC0471-0119 B

Drug

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.

The study will last 1-4 months

NNC0471-0119 D

Drug

NNC0471-0119 administered once via an insulin pump as one bolus dose on top of a continuous basal rate.

The study will last 1-4 months

Faster Aspart

Drug

Faster aspart administered once via an insulin pump as one bolus dose on top of a continuous basal rate.

The study will last 1-4 months

Primary outcomes

  1. AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)

    Time frame: 0 to 12 hours after bolus infusion

    Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in percentage

Secondary outcomes

  1. AUC (NNC0471-0119,0-t,basal-corrected)

    Time frame: 0 to 12 hours after bolus infusion

    Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in h*pmol/L

  2. AUC (NNC0471-0119,0-30min,basal-corrected)

    Time frame: 0 to 30 minutes after bolus infusion

    Area under the basal-corrected serum NNC0471-0119 concentration time curve from 0 to 30 minutes.

    Measured in h*pmol/L

  3. AUC (NNC0471-0119,2h-t,basal-corrected)

    Time frame: 2 to 12 hours after bolus infusion

    Area under the basal-corrected serum NNC0471-0119 concentration time curve from 2 hours to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in h*pmol/L

  4. AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)

    Time frame: 0 to 12 hours after bolus infusion

    Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 2 hours to t and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in percentage

  5. Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration

    Time frame: 0 to 12 hours after bolus infusion

    pmol/L

  6. Number of adverse events (AEs)

    Time frame: From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6)

    Number of events

  7. AUC (GIR,0-t,basal-corrected)

    Time frame: 0 to 12 hours after bolus infusion

    Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in mg/kg

  8. AUC (GIR,0-1h,basal-corrected)

    Time frame: 0 to 1 hour after bolus infusion

    Area under the basal-corrected GIR-time curve from 0 to 1 hour. Measured in mg/kg

  9. AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected)

    Time frame: 0 to 12 hours after bolus infusion

    Ratio of the area under the basal-corrected GIR-time curve from 0 to 1 hour and 0 to t, where t is the first time the GIR curve is back to basal level after bolus infusion (at most 12 hours).

    Measured in percentage

  10. GIRmax,basal-corrected: Maximum observed basal-corrected GIR

    Time frame: 0 to 12 hours after bolus infusion

    mg/(kg*min)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of Three Formulations of NNC0471-0119 When Administered as One Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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