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insulin 287

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Trials Updated: Mar 1, 2017

insulin 287 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2013

insulin 287 target and mechanism

Molecular targetINSR
Target classAgonist
ModalitySmall molecule

Also known as Insulin icodec

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

insulin 287 clinical trials

insulin 287 · 1 trial · 2 indications

Phase 1 1
NCT01809184A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy SubjectsDiabetes
COMPLETED84 Analytics
PHASE1COMPLETED
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events (AEs)
As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)

Secondary Endpoints

Area under the serum insulin concentration-time curve
From 0 to 648 hours after a single dose
Area under the glucose infusion rate (GIR)-time curve
From 0 to 24 hours after a single dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 1EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 2EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 3EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 4EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 5EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 6EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.
Dose level 7EXPERIMENTALEach subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Interventions

NameTypeDescription
insulin 287DRUGOrally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
insulin glargineDRUGInsulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
placeboDRUGOral placebo adminstered corresponding to insulin 287 treatment
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index 18.0-28.0 kg/m\^2 * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investig...

Countries:Germany
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Competitive Landscape -Diabetes Complications 8 trials (matched to "Diabetes")

No competing companies are currently tracked in active development for Diabetes Complications.
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Frequently asked questions about insulin 287

What is insulin 287?

Insulin 287 is an investigational small molecule drug being developed by Novo Nordisk A/S for diabetes. It is designed as an agonist of the insulin receptor (INSR). It has completed a Phase 1 clinical trial in healthy subjects, and it is not an approved therapy.

What does insulin 287 target?

Insulin 287 targets the insulin receptor, also known as INSR. It acts as an agonist at this receptor. The insulin receptor mediates the metabolic effects of insulin, and agonism of INSR is the mechanism under investigation for this small molecule in diabetes.

Who makes insulin 287?

Insulin 287 is being developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program for this investigational small molecule agonist of the insulin receptor.

What phase is insulin 287 in?

Insulin 287 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved for any indication, including diabetes.

What clinical trials is insulin 287 in?

Insulin 287 has been studied in one completed Phase 1 trial, NCT01809184. That trial investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of NNC0148-0000-0287 in healthy subjects. It enrolled 84 participants in Germany, was randomized, double blind, and controlled, and included male healthy volunteers aged 18 years and older.

What is insulin 287 used for in diabetes?

Insulin 287 is being investigated for diabetes, including type 2 diabetes mellitus. It is an experimental small molecule insulin receptor agonist in Phase 1 development. It is not approved or available for treating diabetes, and its safety and efficacy have not been established.