NCT01053728 is a Phase 1/Phase 2 clinical trial of SAR161271 in Type 1 Diabetes Mellitus, sponsored by Sanofi.

Who is sponsoring NCT01053728?

NCT01053728 is sponsored by Sanofi.

What drugs are being tested in NCT01053728?

Interventions in NCT01053728: SAR161271, Insulin glargine HOE901.

What condition does NCT01053728 study?

NCT01053728 studies Type 1 Diabetes Mellitus.

Is NCT01053728 still recruiting?

NCT01053728 is currently completed. Last updated 25 July 2011.

Last reviewed 2011-07-25 · How we verify

NCT01053728

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

Randomized, Double-blind, Euglycemic Glucose Clamp Study of Four Formulations of SAR161271, in Single Doses in Healthy Subjects and Single Ascending Doses in Patients With Type 1 Diabetes Mellitus

Completed Phase 1/Phase 2 Last updated 25 July 2011

What this trial tests

Phase 1/Phase 2 trial testing SAR161271 in Type 1 Diabetes Mellitus in 46 participants. Completed in 1 November 2010.

Timeline

1 February 2010

Primary endpoint
1 May 2010

1 November 2010

Quick facts

Lead sponsor	Sanofi
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	1 February 2010
Primary completion	1 May 2010
Estimated completion	1 November 2010
Sites	1 location across Germany

Drugs / interventions tested

SAR161271 — full drug profile →
Insulin glargine HOE901

Conditions studied

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

Sponsor

Sanofi — full company profile →

Who can join

Adults 18 to 60, male only, with Type 1 Diabetes Mellitus. 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.

- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
Time frame: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
Time frame: up to 30 hours after dose

Sponsor's own description

Primary Objective: \- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM. Secondary Objective: \- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM

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 Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · 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 NCT01053728 (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 Sanofi
Last refreshed: 25 July 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/NCT01053728.

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