Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05960656 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

SGLTi, Hepatic Glucose Production and Ketogenesis

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 250 wordsv8
  2. Phase: Early Phase 1 to Phase 1v7 Show 8 more changesShow less
    • Enrollment target: 169 to 30
    • Primary endpoints: 4 to 1
    • Interventions: Empagliflozin 25 MG (Drug), Pioglitazone 30mg (Drug), Pioglitazone 30mg + Empagliflozin (25 mg) (Drug), Placebo (Other) to Empagliflozin 25 MG (Drug), Placebo (Other)
    • Eligibility criteria shortened, about 142 words
    • Secondary endpoints shortened, about 11 words
    • Study description shortened, about 1,412 words
    • Study arms: 4 to 2
    • Study title expanded, about 1 word
  3. Re-verified, no change to tracked fieldsv6
  4. Enrollment target: 30 to 169v5 Show 7 more changesShow less
    • Primary endpoints revised (4)
    • Primary completion date: Dec 31, 2026 to Jun 1, 2027
    • Interventions: Empagliflozin 25 MG (Drug), Placebo (Other) to Empagliflozin 25 MG (Drug), Pioglitazone 30mg (Drug), Pioglitazone 30mg + Empagliflozin (25 mg) (Drug), Placebo (Other)
    • Eligibility criteria expanded, about 145 words
    • Secondary endpoints: 4 to 3
    • Study description expanded, about 1,540 words
    • Study arms: 2 to 4
  5. Primary completion date: Dec 2024 to Dec 31, 2026
    • Study completion date: Jan 2025 to Jun 30, 2027
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Oct 5, 2023
    • Site details revised
    v3
  2. Primary endpoints revised (4)
    • Secondary endpoints: details revised at 4 of 4 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this study, we will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. MAIN STUDY: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects.
Trial Details
NCT Number NCT05960656
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov