NCT04030091 is a Phase 4 clinical trial of 3 hours humulin R 100 IU/mL PIT in Diabetes Mellitus, Type 2, sponsored by Sciema UG.

Who is sponsoring NCT04030091?

NCT04030091 is sponsored by Sciema UG.

What drugs are being tested in NCT04030091?

Interventions in NCT04030091: 3 hours humulin R 100 IU/mL PIT, 2 hours humulin R 100 IU/mL PIT.

What condition does NCT04030091 study?

NCT04030091 studies Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1.

Is NCT04030091 still recruiting?

NCT04030091 is currently completed. Last updated 1 April 2021.

Last reviewed 2021-04-01 · How we verify

NCT04030091

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

Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus

Completed Phase 4 Last updated 1 April 2021

What this trial tests

Phase 4 trial testing 3 hours humulin R 100 IU/mL PIT in Diabetes Mellitus, Type 2 in 24 participants. Completed in 31 December 2020.

Timeline

6 September 2019

Primary endpoint
19 October 2020

31 December 2020

Quick facts

Lead sponsor	Sciema UG
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	6 September 2019
Primary completion	19 October 2020
Estimated completion	31 December 2020
Sites	2 locations across United States, Germany

Drugs / interventions tested

3 hours humulin R 100 IU/mL PIT — full drug profile →
2 hours humulin R 100 IU/mL PIT — full drug profile →

Conditions studied

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

Sponsor

Sciema UG — full company profile →

Who can join

Adults 18 to 99, any sex, with Diabetes Mellitus, Type 2 or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open label, prospective, randomised comparative, single center study. In the present study, the impact of a 12-week pulsatile insulin infusion therapy (PIT) with Humulin R 100 from

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 Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other Sciema UG trials

Trials by the same sponsor.

NCT06063759 — Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabet · NA · suspended
NCT04868214 — Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verif · unknown
NCT04027023 — Evaluation of the Impact of Intensive Short-Term Drug Therapy in Patients With Type 2 Diabetes Mellitus · Phase 4 · unknown
NCT04340648 — Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect · NA · completed
NCT04379427 — Measurement Algorithm Control and Optimization With Subsequent Performance Evaluation of Sanmina Non-invasive Biosensors · NA · completed

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 NCT04030091 (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 Sciema UG
Last refreshed: 1 April 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/NCT04030091.

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