🏛️ Verified NIH Record • Updated 2026-05-28

Triple Therapy in T1DM (NCT03899402)

Triple Therapy for Type 1 Diabetes With Insulin, Semaglutide, and Dapagliflozin

🔵 Active, Not Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: State University of New York at Buffalo

🩺 Plain-English Summary (8th-Grade Level)

To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (33 items).

Location: Diabetes and Endocrinology Research Center of WNY — Williamsville, New York

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY
  • Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.
  • History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit
  • Frequent episodes of severe hypoglycemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), and/or glucagon therapy administered by a third-party individual within 1 month prior to the screening visit
  • Symptoms of poorly controlled diabetes that would preclude participation in this trial
  • Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
  • History of bariatric surgery or lap-band procedure within 12 months prior to screening
  • History of Addison's disease or chronic adrenal insufficiency
  • History of diabetes insipidus
  • Hepatic disease or cirrhosis with Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN
  • Serum Total Bilirubin \> 2X ULN unless exclusively caused by Gilbert's Syndrome

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Diabetes and Endocrinology Research Center of WNY — Williamsville, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗