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Triple Therapy in T1DM | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

Triple Therapy in T1DM

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

NCT03899402•State University of New York at Buffalo

Summary

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.

Detailed Description

This will be a 52 week study for type 1 diabetics looking into the effect of semaglutide and dapagliflozin on HbA1c and glycemic control.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Type 1 Diabetes for at least 1 year on staple use of continuous subcutaneous insulin infusion (CSII) or multiple daily (four or more) injections (MDI) of insulin for last 3 months.
•2. C-peptide \<0.23 nM
•3. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
•4. Regularly measuring blood sugars four or more times daily.
•5. HbA1c of \>7.5%.
•6. Well versed in CHO counting\*
•7. Age 18-70 years.
•8. BMI ≥25 kg/m2.

Exclusion Criteria

•1. Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY
•2. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.
•3. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit
•4. 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
•5. Symptoms of poorly controlled diabetes that would preclude participation in this trial
•6. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
•7. History of bariatric surgery or lap-band procedure within 12 months prior to screening
•8. History of Addison's disease or chronic adrenal insufficiency
•9. History of diabetes insipidus
•10. Hepatic disease or cirrhosis with Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN
+22 more criteria

Locations (1)

Diabetes and Endocrinology Research Center of WNY

Williamsville, New York, United States

Key Dates

Start Date

May 1, 2019

Primary Completion Date

January 31, 2026

Completion Date

March 31, 2026

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Type 1 Diabetes Mellitus

Interventions

Insulin

DRUG

Semaglutide

DRUG

Dapagliflozin

DRUG

Placebo to Dapagliflozin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

NCT06390371

Type 1 Diabetes Mellitus

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Triple Therapy in T1DM

Inclusion Criteria

Exclusion Criteria

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