Triple Therapy in T1DM

NCT03899402 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000027751987
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c following dapagliflozin

  Change in HbA1c at 6 months following dapagliflozin or placebo therapy in addition to combined semaglutide and insulin treatment.

  6 months

Secondary Outcomes (22)

• Change in HbA1c with triple therapy

  12 months

• Change in HbA1c with semaglutide

  6 months

• Assessment of hyperglycemia level 1

  12 months

• Assessment of hyperglycemia level 2

  12 months

• Assessment of hypoglycemia

  12 months

Study Arms (4)

Control

ACTIVE COMPARATOR

Standard of care insulin will be used as an active comparator arm for 1/3 of patients (38 patients) for the entire duration of the study.

Drug: Insulin

Dual Therapy

EXPERIMENTAL

Once a week injection of Semaglutide (a GLP-1 receptor agonist) in addition to standard of care insulin for the first six months in 2/3 of patients (76 patients). Semaglutide is a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector. Semaglutide will be started at the 0.25 mg dose for the first two weeks, then increased to 0.5 mg at week 2, and then yet again increased to 1.0 mg at week 4.

Drug: Insulin; Drug: Semaglutide

Triple therapy

EXPERIMENTAL

Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of Dapagliflozin (an SGLT-2 inhibitor) added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)). Dapagliflozin will be started at 5 mg for one week, and then increased to 10 mg for the remainder of the study

Drug: Insulin; Drug: Semaglutide; Drug: Dapagliflozin

Triple therapy control

PLACEBO COMPARATOR

Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of the Placebo form of Dapagliflozin added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)).

Drug: Insulin; Drug: Semaglutide; Drug: Placebo to Dapagliflozin

Interventions

Placebo to Dapagliflozin DRUG

Placebo to Dapagliflozin given as a control to the experimental drug

Triple therapy control

Insulin DRUG

Standard of care insulin for pump or injection and serves as a control

Control; Dual Therapy; Triple therapy; Triple therapy control

Semaglutide DRUG

Injectable weekly GLP-1RA given as open label experimental drug

Also known as: Ozempic

Dual Therapy; Triple therapy; Triple therapy control

Dapagliflozin DRUG

Oral daily SGLT2 Inhibitor given as experimental drug

Also known as: Farxigo

Triple therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• C-peptide \<0.23 nM
• Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
• Regularly measuring blood sugars four or more times daily.
• HbA1c of \>7.5%.
• Well versed in CHO counting\*
• Age 18-70 years.
• BMI ≥25 kg/m2.

You may not qualify if:

• 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
• Hemoglobin \< 11.0 g/dL (110 g/L) for men; hemoglobin \< 10.0 g/dL (100 g/L) for women.
• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months or patients with congestive heart failure.
• ESRD on hemodialysis; and or e-GFR \< 60 ml/min/1.73m2
• HIV or Hepatitis B/C positive status

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• University of Glasgow: collaborator
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Diabetes and Endocrinology Research Center of WNY

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin; semaglutide; dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Husam Ghanim, PhD

  State University of NY at Buffalo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This will be a two-center, randomized, open-label then double-blind, parallel group, placebo and standard of care controlled prospective study in type 1 diabetes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor, Head of Endocrinology, Diabetes, and Metabolism, State University of New York

Model Details: This will be a two-center, randomized, open-label then double-blind, parallel group, placebo and standard of care controlled prospective study in type 1 diabetes.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 2, 2019
• Study Start: May 1, 2019
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)