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

NCT01809184 | Completed Phase 1

• 3 other identifiers: NN1956-40142012-003048-66U1111-1132-1018
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of adverse events (AEs)

  As recorded from trial product administration and until completion of Sub-visit 2G (Day 13)

Secondary Outcomes (2)

• Area under the serum insulin concentration-time curve

  From 0 to 648 hours after a single dose

• Area under the glucose infusion rate (GIR)-time curve

  From 0 to 24 hours after a single dose

Study Arms (7)

Dose level 1

EXPERIMENTAL

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

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

Dose level 2

EXPERIMENTAL

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

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

Dose level 3

EXPERIMENTAL

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

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

Dose level 4

EXPERIMENTAL

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

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

Dose level 5

EXPERIMENTAL

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

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

Dose level 6

EXPERIMENTAL

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

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

Dose level 7

EXPERIMENTAL

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

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

Interventions

insulin 287 DRUG

Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.

Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5; Dose level 6; Dose level 7

insulin glargine DRUG

Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.

Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5; Dose level 6; Dose level 7

placebo DRUG

Oral placebo adminstered corresponding to insulin 287 treatment

Dose level 1; Dose level 2; Dose level 3; Dose level 4; Dose level 5; Dose level 6; Dose level 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 12, 2013
• Study Start: March 4, 2013
• Primary Completion: September 6, 2013
• Study Completion: September 6, 2013
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

DE (1)