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NNC0268-0965

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 10, 2024

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04575181A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin GlarginePHASE1 COMPLETED 86Oct 21, 2020Dec 24, 2021Jan 10, 20242 Germany
NCT04136067A Study to Look at How Safe NNC0268-0965 is in People With Type 2 DiabetesPHASE1 COMPLETED 36Oct 29, 2019Aug 23, 2020Sep 8, 20221 Germany
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Study Endpoints
Primary Endpoints
Change in flow mediated dilation
From Visit 3B (week 0) to visit 30B (week 26)

Percent

Number of treatment-emergent adverse events (AEs)
From IMP administration at day 1 (visit 2) until completion of post-treatment end-of-trial visit at day 12 (visit 5)

Number of events

Secondary Endpoints
Change in pulse wave velocity
From Visit 3B (week 0) to visit 30B (week 26)
Change in leg blood flow
From Visit 3B (week 0) to visit 30B (week 26)
Change in retinal arteriolar dilation
From Visit 3A (week 0) to visit 30A (week
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0286-0965EXPERIMENTALNNC0286-0965 administered together with insulin glargine placebo. If previously treated with oral anti-diabetic drugs (OADs), participants will remain on these in the trial
Insulin glargineACTIVE_COMPARATORInsulin glargine administered together with NNC0286-0965 placebo. If previously treated with OADs, participants will remain on these in the trial
NNC0268-0965EXPERIMENTALParticipants will receive NNC0268-0965
Interventions
NameTypeDescription
NNC0268-0965DRUGFor subcutaneous (s.c., under the skin) injection once daily for 26 weeks
Insulin glargineDRUGFor s.c. injection once daily for 26 weeks
Placebo (NNC0268-0965)DRUGFor s.c. injection once daily for 26 weeks
Placebo (insulin glargine)DRUGFor s.c. injection once daily for 26 weeks
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Aged 40-75 years (both inclusive) at the time of signing informe...

Countries:Germany
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