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insulin 287

Phase 1

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

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

Clinical trial landscape

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
Diabetes
NCT0180918484
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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 6 trials (matched to "Diabetes")

CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2N/AUndisclosed
Integra LifeSciences Holdings CorporationIART1N/AUndisclosed
Organogenesis Holdings, Inc. Class AORGO1N/AUndisclosed
Healthcare Services Group, Inc.HCSG1N/AUndisclosed
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