A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes

NCT ID: NCT03945656

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2021-09-27

Brief Summary

This study is comparing the effect of a long-acting insulin analogue (insulin 287) with insulin glargine (Lantus®) in subjects with type 2 diabetes. In addition, the study is looking at symptoms of low blood sugar, awareness of low blood sugar and the time and amount of glucose needed to recover from low blood sugar after injecting 2 and 3 times the basal dose of insulin 287 and glargine. The purpose of the study is to make a once-weekly injectable basal insulin treatment for people with type 2 diabetes. Participants will get insulin 287 as well as insulin glargine - which treatment any participant gets first is decided by chance. Insulin 287 is a new medicine; insulin glargine can already be prescribed. The study medicines will be in a pen, and must be injected with a needle in the thigh once per day (insulin glargine) or once per week (insulin 287). The study will last for minimum 3 months and up to approximately 6 months. Participants will have 21 clinic visits and at least 2 phone calls with the study doctor. The participants' health will be monitored carefully and blood samples will be taken at the clinic visits.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin 287 followed by insulin glargine

Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment.

After run-in, participants will receive insulin 287 once a week (OW) for 6 weeks.

After insulin 287 treatment, participants will receive insulin glargine U100 OD for 12 days.

Group Type: EXPERIMENTAL

insulin icodec

Intervention Type: DRUG

Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks

Insulin glargine

Intervention Type: DRUG

Participants will receive daily s.c. injections of insulin glargine U100 for 12 days

Insulin glargine followed by insulin 287

Run-in period (3 to 28 days): Once daily insulin glargine treatment with or without any usual metformin treatment.

After run-in, participants will receive insulin glargine U100 OD for 12 days.

After insulin glargine treatment, participants will receive insulin 287 OW for 6 weeks.

Group Type: ACTIVE_COMPARATOR

insulin icodec

Intervention Type: DRUG

Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks

Insulin glargine

Intervention Type: DRUG

Participants will receive daily s.c. injections of insulin glargine U100 for 12 days

Interventions

insulin icodec

Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks

Intervention Type: DRUG

Insulin glargine

Participants will receive daily s.c. injections of insulin glargine U100 for 12 days

Intervention Type: DRUG

Other Intervention Names

Insulin 287

Eligibility Criteria

Inclusion Criteria

• Male or female, aged between 18 and 72 years (both inclusive) at the time of signing informed consent.
• Body mass index between 18.5 and 37.9 kg/m^2 (both inclusive).
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening.
• Glycosylated haemoglobin type A1c (HbA1c) less than or equal to 9.0% (less than or equal to 74 mmol/mol) at screening.
• Current total daily insulin treatment between 0.2 and 1.0 U/kg/day (both inclusive).

Exclusion Criteria

• Known or suspected hypersensitivity to trial products or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Graz, , Austria

Countries

Austria

References

Pieber TR, Arfelt KN, Cailleteau R, Hart M, Kar S, Mursic I, Svehlikova E, Urschitz M, Haahr H. Hypoglycaemia frequency and physiological response after double or triple doses of once-weekly insulin icodec vs once-daily insulin glargine U100 in type 2 diabetes: a randomised crossover trial. Diabetologia. 2023 Aug;66(8):1413-1430. doi: 10.1007/s00125-023-05921-8. Epub 2023 Jun 13.

Reference Type: BACKGROUND

PMID: 37308751 (View on PubMed)

Other Identifiers

U1111-1214-2688

Identifier Type: OTHER

Identifier Source: secondary_id

2018-001993-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN1436-4462

Identifier Type: -

Identifier Source: org_study_id