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NNC0143-0406

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Feb 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials2
Total Enrollment95

FDA Designations

No designations recorded

Clinical trial landscape

NNC0143-0406 · 2 trials · 2 indications

Phase 1 2
NCT02938572A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes MellitusDiabetes
COMPLETED47 Analytics
NCT02612844A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 DiabetesDiabetes
COMPLETED48 Analytics
PHASE1COMPLETED
A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus
DiabetesUnlock trial analytics
PHASE1COMPLETED
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0143-0406 A 0.6 mmol/L in Subjects With Type 1 Diabetes
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

The ratio of suppression of endogenous glucose production relative to total glucose lowering effect
Two weeks of treatment
The number of treatment emergent adverse events
From the time of dosing (Visit 2,Day 1) and until completion of the post-treatment follow-up visit (Visit 3) i.e. 11-13 days.

Secondary Endpoints

Number of treatment emergent adverse events
Time of first trial product administration to 7 days (7 times 24 hours) after last trial product administration
Area under the serum NNC0143-0406 concentration-time curve
From 0 to 24 hours
Area under the glucose infusion rate-time curve
From 0 to 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0143-0406EXPERIMENTAL -
Insulin aspartACTIVE_COMPARATOR -

Interventions

NameTypeDescription
NNC0143-0406DRUGAdministered subcutaneously (s.c. under the skin)
Insulin AspartDRUGAdministered subcutaneously (s.c. under the skin)
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female aged 18-55 years (both inclusive) at the time of signing informed consent * Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening * Treated with continuous subcutaneous insulin infusion at least 90 days pri...

Countries:Austria
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about NNC0143-0406

What is NNC0143-0406 used for in diabetes?

NNC0143-0406 is an investigational small molecule being developed by Novo Nordisk A/S for the treatment of diabetes, specifically type 1 diabetes. It is administered subcutaneously and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes NNC0143-0406?

NNC0143-0406 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with type 1 diabetes.

What phase is NNC0143-0406 in?

NNC0143-0406 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving patients with type 1 diabetes. The drug is investigational and has not yet received regulatory approval for any use.

What clinical trials is NNC0143-0406 in?

NNC0143-0406 has been studied in two completed Phase 1 trials: NCT02612844, which investigated safety, tolerability, pharmacokinetics, and pharmacodynamics in 48 male subjects with type 1 diabetes, and NCT02938572, a proof-of-principle trial in 47 subjects with type 1 diabetes. Both trials were conducted in Austria.

Is NNC0143-0406 the same as any other drug?

NNC0143-0406 is the sole name provided for this investigational drug. No alternative names have been reported. It is a small molecule being developed by Novo Nordisk for type 1 diabetes and is currently in Phase 1 clinical trials.