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IGlar U100

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Mar 11, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03723772A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a WeekPHASE1 COMPLETED 66 — — Nov 29, 2018Jun 26, 2020Mar 11, 20251 Germany
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Study Endpoints
Primary Endpoints
AUCI287,τ,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state
From 0 to 168 hours after trial product administration (Day 50)

Measured in pmol\*h/L

Secondary Endpoints
AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
From 16 to 52 hours after trial product administration (Day 50)
AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state
From 138 to 168 hours after trial product administration (Day 50)
GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state
From 16 to 52 hours after trial product administration (Day 50)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Insulin 287 followed by insulin glargine U100EXPERIMENTALRun-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling where subjects are treated with once daily (OD) insulin glargine. After insulin 287 treatment, participants will receive insulin glargine U100 OD for 2 weeks.
Insulin glargine U100 followed by insulin 287EXPERIMENTALRun-in period (2 days to 4 weeks): The basal insulin glargine dose for each subject will be established and optimised. After run-in, participants will receive insulin glargine U100 OD for 2 weeks followed by 1-14 days (at least 1 day is mandatory) of continued insulin glargine treatment. After insulin glargine treatment, participants will receive insulin 287 once a week (OW) for 8 weeks and subsequent 4 weeks of terminal pharmacokinetic sampling.
Interventions
NameTypeDescription
Insulin icodecDRUGParticipants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
IGlar U100DRUGParticipants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * Current daily basal insulin treatment greater than or equal to 0.2 U/kg/day * Bod...

Countries:Germany
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