Who is sponsoring NCT01120444?

NCT01120444 is sponsored by Becton, Dickinson and Company.

What drugs are being tested in NCT01120444?

Interventions in NCT01120444: BD Research Catheter with 34G x 1.5 mm needle, Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set.

Is NCT01120444 still recruiting?

NCT01120444 is currently completed. Last updated 15 April 2011.

Last reviewed 2011-04-15 · How we verify

NCT01120444

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

A Single Center, Open-label, Randomized Study Examining the Glycemic Effects of ID vs SC Bolus Dosing of Insulin Lispro in Patients With Type 1 Diabetes

Completed Phase 1/Phase 2 Last updated 15 April 2011

What this trial tests

Phase 1/Phase 2 trial testing BD Research Catheter with 34G x 1.5 mm needle in Diabetes in 20 participants. Completed in 1 October 2010.

Timeline

1 April 2010

Primary endpoint
1 October 2010

1 October 2010

Quick facts

Lead sponsor	Becton, Dickinson and Company
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	1 April 2010
Primary completion	1 October 2010
Estimated completion	1 October 2010
Sites	1 location across Germany

Drugs / interventions tested

BD Research Catheter with 34G x 1.5 mm needle
Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set

Conditions studied

Diabetes — all drugs for Diabetes →

Sponsor

Becton, Dickinson and Company — full company profile →

Who can join

Adults 18 to 55, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Blood Glucose
Time frame: 12-14 hours
To compare between the ID and SC routes the relative PD times "in-range" (70-180 mg/dL) for glycemic excursions following two types of standardized meals and three dose ranges (optimum dose and +/- 30%).

Sponsor's own description

The purpose of this study is to compare the effects of bolus delivery of insulin when delivered either intradermally (in the skin) or subcutaneously (under the skin) in diabetics.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Microneedle-Mediated Transdermal Delivery of Biopharmaceuticals.
Nguyen HX, Nguyen CN. · · 2023 · cited 69× · PMID 36678906 · DOI 10.3390/pharmaceutics15010277
Microneedle Arrays Combined with Nanomedicine Approaches for Transdermal Delivery of Therapeutics.
Alimardani V, Abolmaali SS, Yousefi G, Rahiminezhad Z, et al · · 2021 · cited 53× · PMID 33419118 · DOI 10.3390/jcm10020181
Microneedle-based insulin transdermal delivery system: current status and translation challenges.
Zhao J, Xu G, Yao X, Zhou H, et al · · 2022 · cited 51× · PMID 34671948 · DOI 10.1007/s13346-021-01077-3
Pharmacokinetics and postprandial glycemic excursions following insulin lispro delivered by intradermal microneedle or subcutaneous infusion.
McVey E, Hirsch L, Sutter DE, Kapitza C, et al · · 2012 · cited 32× · PMID 22920798 · DOI 10.1177/193229681200600403

Verify or expand the search:

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Other Becton, Dickinson and Company trials

Trials by the same sponsor.

NCT06632509 — BD SiteRite(TM) 9 Ultrasound System - Clinical Study · completed
NCT06632496 — BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study · completed
NCT06604026 — Investigational Study With the BD PosiFlush™ SafeScrub on NADs · NA · recruiting
NCT06426121 — Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product · completed
NCT05953363 — Prospective Clinical Evaluation of BD NRFit™ Devices and Accessories. · 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 NCT01120444 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Becton, Dickinson and Company
Last refreshed: 15 April 2011

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/NCT01120444.

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