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NNC0268-0965

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 10, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

NNC0268-0965 · 3 trials · 3 indications

Phase 1 3
NCT04575181A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin GlargineDiabetes Mellitus, Type 2
COMPLETED86 Analytics
NCT04136067A Study to Look at How Safe NNC0268-0965 is in People With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED36 Analytics
NCT03965013A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED78 Analytics
PHASE1COMPLETED
A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes
Diabetes Mellitus, Type 2Unlock trial analytics
PHASE1COMPLETED
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics

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

Number of treatment-emergent adverse events
From trial product administration at day 1 until completion of post-treatment end-of-trial visit at day 10

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
Part 1 (healthy): NNC0268-0965EXPERIMENTALA single dose of NNC0268-0965 given s.c. (subcutaneously, under the skin)
Part 1 (healthy): placeboPLACEBO_COMPARATORA single dose of placebo (NNC0268-0965) given s.c.
Part 2 (type 1 diabetes): NNC0268-0965EXPERIMENTALA single dose of NNC0268-0965 given s.c.
Part 2 (type 1 diabetes): insulin glargineACTIVE_COMPARATORA single dose of insulin glargine given s.c.

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
PlaceboDRUGA single dose of placebo given in Part 1
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Eligibility Criteria

Age Range40 Years to 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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Frequently asked questions about NNC0268-0965

What is NNC0268-0965 used for?

NNC0268-0965 is an investigational small molecule being developed for the treatment of Type 1 and Type 2 diabetes mellitus. It is currently in Phase 1 clinical development and has been studied in healthy volunteers as well as in people with these conditions.

Who makes NNC0268-0965?

NNC0268-0965 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is NNC0268-0965 in?

NNC0268-0965 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All completed trials for this drug are Phase 1 studies, and it remains in early-stage clinical testing.

What clinical trials is NNC0268-0965 in?

NNC0268-0965 has been studied in three completed Phase 1 clinical trials. These include NCT03965013 in healthy people and people with Type 1 diabetes, NCT04136067 in people with Type 2 diabetes, and NCT04575181 comparing it with insulin glargine in Type 2 diabetes.

Is NNC0268-0965 the same as insulin glargine?

No, NNC0268-0965 is not the same as insulin glargine. It is a novel investigational medicine being studied in a clinical trial that compares its efficacy and safety with insulin glargine in people with Type 2 diabetes. The two are distinct treatments.