NCT03444467 is a Phase 1 clinical trial of NNC9204-1513 in Diabetes, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT03444467?

NCT03444467 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT03444467?

Interventions in NCT03444467: NNC9204-1513, Glucagon, Placebo.

What condition does NCT03444467 study?

NCT03444467 studies Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2.

Is NCT03444467 still recruiting?

NCT03444467 is currently completed. Last updated 5 September 2018.

Last reviewed 2018-09-05 · How we verify

NCT03444467

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

First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

Completed Phase 1 Last updated 5 September 2018

What this trial tests

Phase 1 trial testing NNC9204-1513 in Diabetes in 36 participants. Completed in 24 May 2018.

Timeline

5 February 2018

Primary endpoint
24 May 2018

24 May 2018

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	36
Start date	5 February 2018
Primary completion	24 May 2018
Estimated completion	24 May 2018
Sites	1 location across Germany

Drugs / interventions tested

NNC9204-1513 — full drug profile →
Glucagon (GLUCAGON) — full drug profile →
Placebo

Conditions studied

Diabetes — all drugs for Diabetes →
Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

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

Sponsor's own description

The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon (GlucaGen®). This is the first time NNC9204-1513 is given to humans. Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is decided by chance (like flipping a coin). Neither the participant nor the study doctor will know which study medicine (NNC9204-1513 or GlucaGen®) the participant is receiving (double -blinding). In case of emergency, this information will be readily available. NNC9204-1513 is a new medicine for rescue treatment of severe low blood sugar and currently not available on the market (doctors cannot prescribe this medicine). The participant will receive two or three single injections below the skin. One injection will contain NNC9204-1513 or GlucaGen®. The other injection will include placebo - this is a product that looks like the actual study drug but without any active ingredients. If a third injection is given, this will contain NNC9204-1513 or placebo. NNC9204-1513 and GlucaGen® will be given using different devices and volumes. In order to mask these external differences, a "double dummy" approach will be used, that means when you get either of the study medicine (NNC9204-1513 or GlucaGen®) you will get another injection which contains no medicine called 'placebo' (it will not have any effect on the body). Dependent on the injection volume to be administered, injections are given by either syringe with needle or an injection pen (NovoPen Echo®). The study will last for up to 39 days.

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 recruiting trials for Diabetes

Currently open trials in the same condition.

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NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · 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 NCT03444467 (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: 5 September 2018

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/NCT03444467.

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