Clinical trial

A Trial Investigating the Hypoglycaemic Response to Overdosing of NNC0148-0287 C (Insulin 287) in Subjects With Type 2 Diabetes

Name

NN1436-4462

Description

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.

Trial arms

Trial start

2019-05-07

Estimated PCD

2021-09-27

Trial end

2021-09-27

Status

Completed

Phase

Early phase I

Treatment

insulin icodec

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

Arms:

Insulin 287 followed by insulin glargine, Insulin glargine followed by insulin 287

Other names:

Insulin 287

Insulin glargine

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

Arms:

Insulin 287 followed by insulin glargine, Insulin glargine followed by insulin 287

Size

Primary endpoint

Clinically significant hypoglycaemia (Double dose): Clinically significant hypoglycaemia (Plasma glucose [PG] less than 3.0 mmol/L [54 mg/dL]) after 2 times the individualised optimal basal dose of insulin

From start of hypoglycaemia induction after 2 times the individualised optimal basal dose of insulin (day 17 for insulin 287, day 4 for insulin glargine) until termination of the clamp the following day

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 43, 'type': 'ACTUAL'}}

Updated at

2023-09-06

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product