Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
DRUGNNC0363-1063
NNC0363-1063 will be administered subcutaneously.
DRUGPlacebo
Placebo will be administered subcutaneously.
DRUGInsulin degludec
Insulin degludec will be administered subcutaneously.
DRUGInsulin detemir
Insulin detemir will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 1 SAD and Part 3 Meal test are double-blind study parts. Sponsor staff involved in the clinical trial is masked according to company standard procedures. Part 2 is open-label study part.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 SAD: Number of adverse events | From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8) | Measured in number of events. |
| Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose | From IMP administration at day 1 up to 7 days | Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]). |
| Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state | At day 2 of visit 2 and visit 3 after initiation of meal test | Measured in hours\*millimoles per litre (h\*mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 SAD: Number of hypoglycaemic episodes | From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8) | Measured in number of episodes. |
| Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose | Up to 7 days | Measured in hours\*picomoles per litre (h\*pmol/L). |
| Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose | Up to 2 days | Measured in h\*pmol/L. |
| Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose | Up to 7 days | Measured in picomoles per litre (pmol/L). |
| Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose | Up to 7 days | Measured in h\*pmol/L. |
| Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose | Up to 2 days | Measured in h\*pmol/L. |
| Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose | Up to 7 days | Measured in pmol/L. |
| 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 | From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in h\*mmol/L. |
| 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 | From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in h\*mmol/L. |
| 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 | From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in h\*mmol/L. |
| 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 | From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in h\*mmol/L. |
| Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state | At day 2 of visit 2 and visit 3 after initiation of meal test | Measured in millimoles per litre (mmol/L). |
| Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state | At day 2 of visit 2 and visit 3 after initiation of meal test | Measured in hours. |
| 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 | From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in mmol/L. |
| 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 | From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3) | Measured in mmol/L. |
| Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state | At day 2 of visit 2 and visit 3 after last IMP administration | Measured in h\*pmol/L. |
| Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state | At day 2 of visit 2 and visit 3 after last IMP administration | Measured in pmol/L. |
| Part 3 Meal test: Number of adverse events | 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) | Measured in number of events. |
| Part 3 Meal test: Number of hypoglycaemic episodes | 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) | Measured in number of episodes. |
Countries
Germany
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed