A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Type 2 Diabetes Mellitus

Treatments: Drug: insulin degludec; Drug: Insulin icodec; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02148861

U1111-1140-5344 (Other Identifier)

NN1436-4057

2013-001180-22 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of subcutaneously administered NNC0148-0287 (insulin 287) in subjects with type 2 diabetes

Enrollment: 49 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, age between 18 and 64 years (both inclusive) at the time of signing informed consent
• Females of no childbearing potential [if surgically sterilized (i.e. tubal ligation, bilateral oophorectomises or hysterectomised) for at least 3 months or if post-menopausal (i.e. as defined by amenorrhoea for at least 12 months prior to screening and documented by FSH (follicle-stimulating hormone) levels above 40 U/L]
• Body mass index (BMI) between 20.0 and 35.0 kg/m^2 (both inclusive)
• Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months

Exclusion criteria

• Known or suspected hypersensitivity to trial products or related products
• Receipt of any investigational medicinal products within 3 months before screening
• Use of oral antidiabetic drugs (OADs) or glucagon-like peptide-1 (GLP-1) receptor agonists (exenatide, liraglutide) within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Insulin 287 + placebo

Experimental group

Description:

Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).

Treatment:

Drug: placebo

Drug: Insulin icodec

Insulin degludec + placebo

Active Comparator group

Description:

Subjects will receive one of two treatment combinations: either insulin 287 + placebo or insulin degludec + placebo. Dose escalation design (4 dose levels).

Treatment:

Drug: placebo

Drug: insulin degludec