NCT03965013 is a Phase 1 clinical trial of NNC0268-0965 in Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT03965013?

NCT03965013 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT03965013?

Interventions in NCT03965013: NNC0268-0965, Placebo, insulin glargine.

What condition does NCT03965013 study?

NCT03965013 studies Diabetes Mellitus, Type 1, Healthy Volunteers.

Is NCT03965013 still recruiting?

NCT03965013 is currently completed. Last updated 14 January 2021.

Last reviewed 2021-01-14 · How we verify

NCT03965013

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 Diabetes

Completed Phase 1 Last updated 14 January 2021

What this trial tests

Phase 1 trial testing NNC0268-0965 in Diabetes Mellitus, Type 1 in 78 participants. Completed in 14 December 2019.

Timeline

5 June 2019

Primary endpoint
14 December 2019

14 December 2019

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	78
Start date	5 June 2019
Primary completion	14 December 2019
Estimated completion	14 December 2019
Sites	1 location across Germany

Drugs / interventions tested

NNC0268-0965 — full drug profile →
Placebo
insulin glargine (INSULIN GLARGINE) — full drug profile →

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 55, any sex, with Diabetes Mellitus, Type 1 or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is investigating the safety and tolerability of the new medicine NNC0268-0965 (referred to as insulin 965), its concentrations in the blood and its effect on blood sugar for the treatment of diabetes. This first part of the study is conducted in healthy people, while there is a second part involving people with type 1 diabetes. The study will test how insulin 965 is tolerated by the participants' body, how it is taken up in the participants' blood, how long it stays there and how blood sugar is lowered. Participants will either get the new insulin 965 or placebo (an injection that does not contain active medicine) - which treatment you get is decided by chance. It is the first time that insulin 965 is tested in humans. Participants will get one injection of either insulin 965 or placebo under the skin of the left thigh. The study will last for about 5 weeks. Participants will have 6 clinic visits with the study doctor. People cannot be in the study if the study doctor thinks that there are risks for their health.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of NNC0268-0965

Trials testing the same drug.

NCT04575181 — A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine · Phase 1 · completed
NCT04136067 — A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes · Phase 1 · completed

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03965013 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 14 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03965013.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing