NCT03979352: CLASS17

Effect of SGLT2i in Conjunction With the Artificial Pancreas on Improving the Glycemia in T1DM in the Outpatient Setting

Completed Phase 3 Last updated 7 June 2022

What this trial tests

Phase 3 trial testing empagliflozin in Type1 Diabetes Mellitus in 28 participants. Completed in 31 August 2021.

Timeline

1 August 2019

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	28
Start date	1 August 2019
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	2 locations across Canada

Drugs / interventions tested

• empagliflozin (empagliflozin) — full drug profile →
• artificial pancreas

Conditions studied

• Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Who can join

18 and older, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The most advanced configurations of the Artificial Pancreas (AP) have not yet been demonstrated to sufficiently maximize time in target glycemia. One limitation is the challenge of postprandial glycemic control, which currently requires ongoing patient engagement for accurate and detailed bolus dose estimation for meals. Sodium Glucose Linked Transporter 2 Inhibition (SGLT2i) provides an additional mechanism to attenuate post-prandial glycemic excursion, and may represent a strategy that could further alleviate carbohydrate counting burden and improve the performance of AP configurations. This trial aims to compare - using a randomized, masked placebo-controlled, crossover, multicenter design - the efficacy of the SGLT2i empagliflozin 25 mg oral per day each in the setting of single-hormone automated AP and conventional insulin pump therapy on the proportion of time spent in target and in hypoglycemia each during a 4-week day-and-night period. The pilot trial aims to enroll 28 adult patients with type 1 diabetes (T1D) across 2 research sites (one in Toronto and one in Montreal) and includes a 2- week therapy optimization run-in period, 4-weeks for each of the two AP intervention arms, and a 1- week washout in between the pharmacological intervention sequences. Glucose levels will be measured by continuous glucose monitoring (G5, Dexcom Inc.). Insulin will be infused using a subcutaneous infusion pump (t-slim, Tandem Diabetes Care) and communication between pumps and the algorithm will be implemented using Android Smartphone devices and Bluetooth technology communication.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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