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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02148861
Collaborator
(none)
49
Enrollment
1
Location
2
Arms
12.2
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Insulin icodec
  • Drug: insulin degludec
  • Drug: placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multiple Dose Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes
Actual Study Start Date :
May 26, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Insulin 287 + placebo

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

Drug: Insulin icodec
Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
Other Names:
  • insulin 287

    • Drug: placebo
    Administered subcutaneously (s.c., under the skin) once-daily for 35 days
    Active Comparator: Insulin degludec + placebo

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

    Drug: insulin degludec
    Administered once-daily subcutaneously (s.c., under the skin) for 35 days

    Drug: placebo
    Administered subcutaneously (s.c., under the skin) once-daily for 35 days

    Outcome Measures

    Primary Outcome Measures

    1. Number of treatment emergent adverse events [From the first trial product administration at Day 1 until completion of the post-treatment follow-up visit (3-14 days after Visit 9, Day 65)]

    Secondary Outcome Measures

    1. Area under the steady-state serum insulin 287 concentration-time curve [During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)]

    2. area under the glucose infusion rate - time curve at steady-state [At Day 31 and day 35]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Neuss Germany 41460

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT02148861
    Other Study ID Numbers:
    • NN1436-4057
    • 2013-001180-22
    • U1111-1140-5344
    First Posted:
    May 28, 2014
    Last Update Posted:
    Mar 8, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Insulin
    Insulin, Globin Zinc

    Study Results

    No Results Posted as of Mar 8, 2021