A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0287 in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: insulin 287; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809184

NN1956-4014

2012-003048-66 (EudraCT Number)

U1111-1132-1018 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this first human dose trial is to investigate the safety, tolerability, pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (exposure of the trial drug in the body) properties of NNC0148-0000-0287 (insulin 287) in a GIPET® I tablet formulation in healthy subjects.

Enrollment: 84 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index 18.0-28.0 kg/m^2
• Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

• Known or suspected hypersensitivity to trial products or related products
• Previous participation in this trial. Participation is defined as randomised
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator
• Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 7 patient groups

Dose level 1

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 2

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 3

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 4

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 5

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 6

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287

Dose level 7

Experimental group

Description:

Each subject will be randomly assigned to receive either insulin 287, placebo or insulin glargine within the dose group.

Treatment:

Drug: insulin glargine

Drug: placebo

Drug: insulin 287