NCT04201496 (CiQ-SGLT2) is a Phase 1 clinical trial of Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks in Type 1 Diabetes, sponsored by Ananda Basu, MD.

Who is sponsoring NCT04201496?

NCT04201496 is sponsored by Ananda Basu, MD.

What drugs are being tested in NCT04201496?

Interventions in NCT04201496: Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks, Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks, No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks, No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks.

What condition does NCT04201496 study?

NCT04201496 studies Type 1 Diabetes.

Is NCT04201496 still recruiting?

NCT04201496 is currently completed. Last updated 11 August 2022.

Last reviewed 2022-08-11 · How we verify

NCT04201496: CiQ-SGLT2

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

SGLT2 Inhibitor Adjunctive Therapy to Closed Loop Control in Type 1 Diabetes Mellitus

Completed Phase 1 Last updated 11 August 2022

What this trial tests

Phase 1 trial testing Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks in Type 1 Diabetes in 34 participants. Completed in 7 September 2021.

Timeline

24 February 2020

Primary endpoint
7 September 2021

7 September 2021

Quick facts

Lead sponsor	Ananda Basu, MD
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	24 February 2020
Primary completion	7 September 2021
Estimated completion	7 September 2021
Sites	1 location across United States

Drugs / interventions tested

Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks
No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks
No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Ananda Basu, MD

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of this study is to evaluate the safety and efficacy of combining SGLT2 inhibitors with closed loop control (CLC).

Publications & conference data

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

Automated Insulin Delivery with SGLT2i Combination Therapy in Type 1 Diabetes.
Garcia-Tirado J, Farhy L, Nass R, Kollar L, et al · · 2022 · cited 27× · PMID 35255229 · DOI 10.1089/dia.2021.0542
Strategically Playing with Fire: SGLT Inhibitors as Possible Adjunct to Closed-Loop Insulin Therapy.
Pasqua MR, Tsoukas MA, Haidar A. · · 2021 · cited 9× · PMID 34558336 · DOI 10.1177/19322968211035411
Risk of diabetic ketoacidosis caused by sodium glucose cotransporter-2 inhibitors in patients with type 1 diabetes: a systematic review and network meta-analysis of randomized controlled trials.
Liu Y, Yang S, Jiang A, Zou D, et al · · 2024 · cited 2× · PMID 39957850 · DOI 10.3389/fendo.2024.1453067

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · 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 NCT04201496 (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 Ananda Basu, MD
Last refreshed: 11 August 2022

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/NCT04201496.

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