A Research Study of How Different Doses of a New Medicine NNC0148-0287 C (Insulin 287) Work on the Blood Sugar in People With Type 1 Diabetes When it is Taken Once a Week

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0148-0287 C (Insulin 287) at Steady State Conditions in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723772
• Other study ID #: NN1436-4225
• Secondary ID: U1111-1204-89092
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the new long-acting insulin 287 with the marketed insulin glargine for use in type 1 diabetes. The study will test how insulin is taken up in your blood, how long it stays there and how the blood sugar is lowered. The participant will get both of the insulins in a random order. Insulin 287 is a new medicine while insulin glargine is already approved for the treatment of diabetes and can be prescribed by a doctor. The participant 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 4 weeks with daily doses of insulin glargine before you start the insulin 287 period. All doses will be injected under the skin. The study will last for about 16 to 24 weeks. The participant will have 27 visits with the study doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female, aged 18-64 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 29.0 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. Subjects with complications associated to diabetes can be included only if they are judged to be mild by the investigator. Subjects with other comorbidities (e.g. dyslipidaemia, hypertension and hypothyroidism) can be included if they have a stable treatment and are in adequate control according to the judgement of the investigator- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)

• 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 injections of insulin 287 once weekly for 8 weeks
• IGlar U100
Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hovelmann U, Engberg S, Heise T, Kristensen NR, Norgreen L, Zijlstra E, Ribel-Madsen R. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 1 diabetes. Diabetes Obes Metab. 2024 Feb 20. doi: 10.1111/dom.15 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCI287,t,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	AUCGIR,16-52h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state	Measured in mg/kg	From 16 to 52 hours after trial product administration (Day 50)
Secondary	AUCGIR,138-168h,SS (for insulin 287) - Area under the glucose infusion rate-time curve at steady state	Measured in mg/kg	From 138 to 168 hours after trial product administration (Day 50)
Secondary	GIRmax,16-52h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 16 to 52 hours after trial product administration (Day 50)
Secondary	GIRmax,138-168h, SS (for insulin 287) - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 138 to 168 hours after trial product administration (Day 50)
Secondary	AUCGIR,0-24h,SS (for insulin glargine) - 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 (for insulin glargine) - Maximum observed glucose infusion rate at steady state	Measured in mg/(kg*min)	From 0 to 24 hours after trial product administration (Day 14)
Secondary	AUCI287,0-168h,FD (from insulin 287) - 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	Cmax,I287,FD (for insulin 287) - 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,FD (for insulin 287) - 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,SS (for insulin 287) - 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	tmax,I287,SS (for insulin 287) - 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	t½,I287,SS (for insulin 287) - 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 (for insulin 287) - Serum insulin 287 trough concentration	Measured in pmol/L	Measured at the end of each dosing interval 168 hours after trial product administration (Day 8, 15, 22, 29, 36, 43, 50 and 57)
Secondary	AUCIGlar,t,SS (for insulin glargine) - Area under the serum insulin glargine 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 (for insulin glargine) - Maximum observed serum insulin glargine concentration at steady state	Measured in pmol/L	From 0 to 24 hours after trial product administration (Day 14)
Secondary	tmax,IGlar,SS (for insulin glargine) - Time to maximum observed serum insulin glargine concentration at steady state	Measured in hours	From 0 to 24 hours after trial product administration (Day 14)
Secondary	CIGlar,trough (for insulin glargine) - Serum insulin glargine trough concentration	Measured in pmol/L	Measured at the end of each dosing interval 24 hours after trial product administration (Day 4, 7, 14 and 15)
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)
Secondary	Change in anti-insulin 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 (visit 25, day 106)
Secondary	Change in anti-insulin 287 antibody titres	Number of dilutions	From first insulin 287 administration (Day 1) to Follow-up visit (visit 25, day 106)
Secondary	Positive cross-reactive anti-human insulin antibodies	Number of patients with/without positive cross-reactive anti-human insulin antibodies	At the follow-up visit (Visit 25, day 106)