Trial · Interventional

CompletedPhase 1Registry data

A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

NCTNCT03789578Other idNN1535-4359Other idU1111-1204-8233Other id2017-004538-27Other id2017

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 30 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
Germany
Start: 17 Jan 2019
Primary completion: 10 Oct 2019
Completion: 10 Oct 2019
First posted: 28 Dec 2018
Last update posted: 12 Nov 2024
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20192020

Ph 1
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together
NCT03789578
17 Jan 2019 to 10 Oct 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The study will look at how insulin 287 and semaglutide work in the body, both when given alone or together. This study will look at the way insulin 287 and semaglutide reach and stay in participants' blood after injection when given alone or together. Participants will get 3 study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287, 2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is decided by chance. Participants will get all medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks. The study will last for about 19 to 32 weeks in total.

Interventions

NNC0148-0287semaDrug
SemaglutideDrug
NNC0148-0287Drug

Arms3

Experimental
Semaglutide plus insulin 287
Participants will get a single dose of fixed-ratio combination of insulin 287 and semaglutide (NNC0148-0287sema (treatment C)).
Experimental
Semaglutide alone
Participants will get a single dose of semaglutide (treatment B) alone.
Experimental
Insulin 287 alone
Participants will get a single dose of insulin 287 (NNC0148-0287 (treatment A)) alone.

Primary outcomes2

Outcomes the sponsor listed as primary.

AUCI287, 0-tz, area under the serum insulin 287 concentration-time curve from 0 hours to last quantifiable observation after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
AUCSema,0-tz, area under the plasma semaglutide concentration-time curve from 0 hours to last quantifiable observation after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.

Secondary outcomes(20)

AUCI287,0-∞ area under the serum insulin 287 concentration-time curve from 0 hours to infinity after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol\*h/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
Cmax, I287, maximum observed serum insulin 287 concentration after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol/L for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
tmax, I287, time to maximum observed serum insulin 287 concentration after a single dose
Time frame · 0-840 hours
Registry description
Measured in hour (h) for insulin 287 following administration of a fixed ratio of NNC0148-0287sema and insulin 287.
AUCSema,0-∞, area under the plasma semaglutide concentration-time curve from 0 hours to infinity after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol\*h/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Cmax,Sema, maximum observed plasma semaglutide concentration after a single dose
Time frame · 0-840 hours
Registry description
Measured in pmol/L for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
tmax,Sema, time to maximum observed plasma semaglutide concentration after a single dose
Time frame · 0-840 hours
Registry description
Measured in hour (h) for semaglutide following administration of a fixed ratio of NNC0148-0287sema and semaglutide.
Number of treatment emergent adverse events
Time frame · Day 1 (beginning of each period) to day 36 (end of each period)
Registry description
Count of events.
Number of hypoglycaemic episodes
Time frame · Day 1 (beginning of each period) to day 36 (end of each period)
Registry description
Count of episodes.
Antibodies for insulin 287: Change in anti-insulin 287 binding antibody levels
Time frame · Day -1 (pre-dose), Day 36 (end of period)
Registry description
Measured as percentage B/T following administration of NNC0148 -0287sema and insulin 287.
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies
Time frame · Day 36 (end of period)
Registry description
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Antibodies for insulin 287: Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Time frame · Day 36 (end of period)
Registry description
Percentage of events (yes/no) following administration of NNC0148 -0287sema and insulin 287.
Antibodies for semaglutide: Change in anti-semaglutide binding antibody levels
Time frame · Day -1 (pre-dose), Day 36 (end of period)
Registry description
Measured as percentage B/T following administration of NNC0148 -0287sema
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies
Time frame · Day 36 (end of period)
Registry description
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Antibodies for semaglutide: Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous glucagon-like peptide-1 (GLP-1)
Time frame · Day 36 (end of period)
Registry description
Percentage of events (yes/no) following administration of NNC0148 -0287sema.
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-semaglutide binding antibody levels
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Measured as percentage B/T.
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide binding antibodies cross reacting to endogenous GLP-1
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Percentage of events (yes/no).
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Anti-insulin 287 binding antibody levels
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Measured as percentage B/T.
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-insulin 287 binding antibodies cross reacting to human insulin
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Percentage of events (yes/no).
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Percentage of events (yes/no).
Binding antibodies and in vitro neutralising antibodies (semaglutide only): Occurrence of anti-semaglutide neutralising antibodies cross reacting with endogenous GLP-1
Time frame · Day 151 (follow-up/end-of-trial visit)
Registry description
Percentage of events (yes/no).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

6 results

Pharmacokinetic Properties of a Once-Weekly Fixed-Ratio Combination of Insulin Icodec and Semaglutide Compared with Separate Administration of Each Component in Individuals with Type 2 Diabetes Mellitus.

Westergaard et al. 2024Clinical drug investigationcited by 11

PMID 39488821PMC11564230DOI 10.1007/s40261-024-01405-8PUB-39488821

Free to read · publisher termsCC BY-NC6 results

Read at source See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 64 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 2 diabetes mellitus more than or equal to 180 days prior to the day of screening * Body weight between 80.0 to 120.0 kg (both inclusive) * Glycosylated haemoglobin (HbA1c) 6.0 to 8.5% (both inclusive) * No current and no regular previous intake of insulin. Previous insulin treatment for short periods of time (a maximum of 14 days) is allowed, as well as insulin use during a previous period of gestational diabetes in the past (as declared by the subject or reported in the medical records) * Stable daily dose(s) of the following anti-diabetic drug(s)/regimen within the past 90 days prior to the day of screening: a) Any metformin formulation (dose as documented in the subject medical record), b) One other oral antidiabetic drug (dose as documented in the subject medical record) is allowed, but not mandatory: Insulin secretagogue (sulphonylureas), dipeptidyl peptidase 4 (DPP-4) inhibitor and sodium glucose co-transporter 2 (SGLT2) inhibitor Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening * Receipt of any investigational medicinal product within 90 days before screening * History of severe allergies to drugs or foods or a history of severe anaphylactic reaction

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