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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

Primary Purpose

Diabetes, Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin icodec

insulin degludec

placebo

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin 287 + placebo

Insulin degludec + placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events

Secondary Outcome Measures

Area under the steady-state serum insulin 287 concentration-time curve

area under the glucose infusion rate - time curve at steady-state

Full Information

NCT ID

NCT02148861

First Posted

April 22, 2014

Last Updated

March 5, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02148861

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

May 26, 2014 (Actual)

Primary Completion Date

June 1, 2015 (Actual)

Study Completion Date

June 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin 287 + placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Insulin degludec + placebo

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin icodec

Other Intervention Name(s)

insulin 287

Intervention Description

Administered once-weekly subcutaneously (s.c., under the skin) for 35 days

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events

Time Frame

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 Measure Information:

Title

Area under the steady-state serum insulin 287 concentration-time curve

Time Frame

During one dosing interval at steady-state from 0 to 168 h after last dose (Day 29)

Title

area under the glucose infusion rate - time curve at steady-state

Time Frame

At Day 31 and day 35

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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