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NNC0471-0119 A

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 12, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

NNC0471-0119 A · 1 trial · 1 indication

Phase 1 1
NCT05262595A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin PumpDiabetes Mellitus, Type 1
COMPLETED19 Analytics
PHASE1COMPLETED
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

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

AUC (NNC0471-0119,0-t,basal-corrected)
0 to 12 hours after bolus infusion
AUC (NNC0471-0119,0-30min,basal-corrected)
0 to 30 minutes after bolus infusion
AUC (NNC0471-0119,2h-t,basal-corrected)
2 to 12 hours after bolus infusion
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTALA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
Arm 2EXPERIMENTALA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
Arm 3EXPERIMENTALA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
Arm 4ACTIVE_COMPARATORA single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)

Interventions

NameTypeDescription
NNC0471-0119 ADRUGNNC0471-0119 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 BDRUGNNC0471-0119 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 DDRUGNNC0471-0119 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 aspartDRUGFaster 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
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Eligibility Criteria

Age Range18 Years to 24 Years
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Austria
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Frequently asked questions about NNC0471-0119 A

What is NNC0471-0119 A used for?

NNC0471-0119 A is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is designed to be administered via an insulin pump. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does NNC0471-0119 A target?

The specific molecular target of NNC0471-0119 A has not been disclosed. It is a small molecule being studied for its effects on glucose metabolism in people with Type 1 Diabetes Mellitus. The drug is administered via an insulin pump to evaluate how it works in the body.

Who makes NNC0471-0119 A?

NNC0471-0119 A is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes Mellitus.

What phase is NNC0471-0119 A in?

NNC0471-0119 A is in Phase 1 clinical development. A Phase 1 study has been completed, which involved 19 participants with Type 1 Diabetes Mellitus. The drug is still investigational and has not received approval from the FDA or other regulatory agencies.

What clinical trials is NNC0471-0119 A in?

NNC0471-0119 A has one completed clinical trial registered under the identifier NCT05262595. This Phase 1 study examined how the drug works in the body when injected by an insulin pump in people with Type 1 Diabetes. The trial was conducted in Austria and enrolled 19 adult participants.

Is NNC0471-0119 A the same as insulin?

NNC0471-0119 A is an investigational small molecule, not a conventional insulin product. It is being studied for use in Type 1 Diabetes Mellitus, where it is administered via an insulin pump. The drug's mechanism of action is not disclosed, and it is not known to be identical to any approved insulin.