A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

Novo Nordisk A/S117 enrolled

Overview

This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

117

Conditions

Diabetes Mellitus, Type 1

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Part 1A SAD (healthy participants) * Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index between 18.5-29.9 kilogram per square metre( kg/m\^2) (both inclusive) at the day of screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D) * Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index between 18.5-29.9 kg/m\^2 (both inclusive) at the day of screening. * Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening. * Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: Part 1A SAD (healthy participants) * Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D) * Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method. * Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Outcomes

Primary Outcomes

Part 1 SAD: Number of adverse events

Measured in number of events.

Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose

Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).

Time frame: From IMP administration at day 1 up to 7 days

Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state

Measured in hours\*millimoles per litre (h\*mmol/L).

Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

Secondary Outcomes

Part 1 SAD: Number of hypoglycaemic episodes

Measured in number of episodes.

Time frame: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)

Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

Measured in hours\*picomoles per litre (h\*pmol/L).

Time frame: Up to 7 days

Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose

Measured in h\*pmol/L.

Time frame: Up to 2 days

Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose

Measured in picomoles per litre (pmol/L).

Time frame: Up to 7 days

Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose

Measured in h\*pmol/L.

Time frame: Up to 7 days

Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose

Measured in h\*pmol/L.

Time frame: Up to 2 days

Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose

Measured in pmol/L.

Time frame: Up to 7 days

Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state

Measured in h\*mmol/L.

Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state

Measured in h\*mmol/L.

Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state

Measured in h\*mmol/L.

Time frame: From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state

Measured in h\*mmol/L.

Time frame: From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state

Measured in millimoles per litre (mmol/L).

Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state

Measured in hours.

Time frame: At day 2 of visit 2 and visit 3 after initiation of meal test

Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state

Measured in mmol/L.

Time frame: From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state

Measured in mmol/L.

Time frame: From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3)

Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state

Measured in h\*pmol/L.

Time frame: At day 2 of visit 2 and visit 3 after last IMP administration

Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state

Measured in pmol/L.

Time frame: At day 2 of visit 2 and visit 3 after last IMP administration

Part 3 Meal test: Number of adverse events

Measured in number of events.

Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)

Part 3 Meal test: Number of hypoglycaemic episodes

Measured in number of episodes.

Time frame: From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3)

A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes