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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin glargine; Drug: insulin icodec

Study type: Interventional

Funder types: Industry

Identifiers

NCT03945656

NN1436-4462

U1111-1214-2688 (Other Identifier)

2018-001993-74 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Insulin 287 followed by insulin glargine

Experimental group

Description:

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.

Treatment:

Drug: insulin icodec

Drug: Insulin glargine

Insulin glargine followed by insulin 287

Active Comparator group

Description:

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.

Treatment:

Drug: insulin icodec

Drug: Insulin glargine