A Research Study of How Different Amounts of a New Medicine NNC0148-0287 C (Insulin 287) Works on the Blood Sugar of People Who Are Japanese With Type 1 Diabetes When Given Once a Week

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Multiple-dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) for Subcutaneous Administration in Japanese Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766854
• Other study ID #: NN1436-4422
• Secondary ID: U1111-1211-7635
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2018
• Est. completion date: December 9, 2019

Study information

• Verified date: March 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will look at how insulin 287 works, if it is safe and the side effects in people who are Japanese with type 1 diabetes. The study will test how insulin goes through your blood, how long it stays there and how the blood sugar is lowered. Insulin 287 is a new medicine. Insulin glargine is already approved to treat diabetes. The study doctors can prescribe insulin glargine. The participants will get both of the insulins in a random order. The participants will get 8 weekly doses of insulin 287 and 14 daily doses of insulin glargine. There will also be a run-in period of 2 days to 7 weeks when the participants inject insulin glargine every day before they start insulin 287 period or insulin glargine period. All doses will be injected under the skin. During the run-in period, the participants adjust the insulin glargine dose and make their blood sugar levels stable. From the run-in period, the participants will take insulin aspart as bolus insulin. The study will last for about 16 - 28 weeks. The participants will have 24 visits with the study doctor. There will be 3 glucose clamps where the participants' blood sugar is tested over time. The participants cannot be in the study if the study doctor thinks that there are risks for their health.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female, Japanese subjects, aged 20 - 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.

• Body mass index between 18.5 and 28.0 kg/m^2 (both inclusive).

• HbA1c less than or equal to 9.0%.

Exclusion Criteria:

• History or presence of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal or endocrinological conditions (except conditions associated with diabetes mellitus).

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods.

• Known or suspected hypersensitivity to trial products or related products

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin icodec
Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks
• Insulin glargine U100
Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCI287t,SS - Area under the serum insulin 287 concentration-time curve during one dosing interval at steady state	Measured in pmol*h/L	From 0 to 168 hours after trial product administration (day 50)
Secondary	Number of adverse events (AEs)	Number of events	From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar)
Secondary	Number of hypoglycaemic episodes	Number of episodes	From first trial product administration (day 1) to end of last dosing interval (day 57 for insulin 287, day 15 for IGlar) excluding clamp days
Secondary	Change in antiinsulin 287 antibody level	Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)	From first insulin 287 administration (day 1) to follow-up visit (day 106)
Secondary	Change in antiinsulin 287 antibody titres	Number of dilutions.; The antibody titer is calculated by diluting the blood serum sample containing antibody in serial ratios (1:2, 1:4, 1:8, 1:16... and so on). Using an appropriate detection method (e.g., colorimetric, chromatographic, etc.), each dilution is tested for the presence of detectable levels of antibody. The assigned titer value is indicative of the last dilution in which the antibody was detected.	From first insulin 287 administration (day 1) to follow-up visit (day 106)
Secondary	Positive cross-reactive anti-human insulin antibodies	Yes/no. Number of participants who developed/not developed positive cross-reactive anti-human insulin antibodies.	At follow-up visit (day 106)
Secondary	AUCI287,0-168,FD - Area under the serum insulin 287 concentration-time curve after the first dose	Measured in pmol*h/L	From 0 to 168 hours after trial product administration (day 1)
Secondary	tmax,I287,FD - Time to maximum observed serum insulin 287 concentration after the first dose	Measured in hours	From 0 to 168 hours after trial product administration (day 1)
Secondary	Cmax,I287,FD - Maximum observed serum insulin 287 concentration after the first dose	Measured in pmol/L	From 0 to 168 hours after trial product administration (day 1)
Secondary	tmax,I287,SS - Time to maximum observed serum insulin 287 concentration after the last dose	Measured in hours	From 0 to 168 hours after trial product administration (day 50)
Secondary	Cmax,I287,SS - Maximum observed serum insulin 287 concentration after the last dose	Measured in pmol/L	From 0 to 168 hours after trial product administration (day 50)
Secondary	t1/2,I287,SS - Terminal half-life for insulin 287 at steady state	Measured in hours	Terminal part of the serum insulin 287 concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after last trial product administration (day 50)
Secondary	CI287,trough - Serum insulin 287 trough concentration	Measured in pmol/L	Measured at the end of each dosing interval 168 hours after dosing (day 8, 15, 22, 29, 36, 43, 50 and 57)
Secondary	AUCIGlar,t,SS - Area under the serum IGlar concentration-time curve during one dosing interval at steady state	Measured in pmol*h/L	From 0 to 24 hours after trial product administration (day 14)
Secondary	Cmax,IGlar,SS - Maximum observed serum IGlar concentration at steady state	Measured in pmol/L	From 0 to 24 hours after trial product administration (day 14)
Secondary	tmax,IGlar,SS - Time to maximum observed serum IGlar concentration at steady state	Measured in hours	From 0 to 24 hours from trial product administration (day 14)
Secondary	CIGlar,trough - Serum IGlar trough concentration	Measured in pmol/L	Measured at the end of each dosing interval 24 hours after trial product administration (day 7, 14 and 15)
Secondary	AUCGIR,24-48h,SS - Area under the glucose infusion rate-time curve at steady state	Measured in mg/kg	From 24 to 48 hours after trial product administration (day 51)
Secondary	GIRmax,24-48h, SS - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 24 to 48 hours after trial product administration (day 51)
Secondary	AUCGIR,150-168h,SS - Area under the glucose infusion rate-time curve at steady state	Measured in mg/kg	From 150 to 168 hours after trial product administration (day 57)
Secondary	GIRmax,150-168h,SS - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 150 to 168 hours after trial product administration (day 57)
Secondary	AUCGIR,0-24h,SS - Area under the glucose infusion rate-time curve at steady state	Measured in mg/kg	From 0 to 24 hours after trial product administration (day 14)
Secondary	GIRmax,0-24h,SS - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 0 to 24 hours after trial product administration (day 14)