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Insulin

Triple Therapy for Type 1 Diabetes

Phase 2 & 3
Recruiting
Research Sponsored by State University of New York at Buffalo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether adding dapagliflozin to semaglutide and insulin improves glycemic control in patients with type 1 diabetes compared to semaglutide and insulin or insulin only treatment.

Who is the study for?
Adults aged 18-70 with Type 1 Diabetes for at least a year, on stable insulin treatment, and regularly monitoring blood sugar can join. They must have a BMI ≥25 kg/m2 and not be on weight loss programs or intensive exercise. Excluded are those with recent severe hypoglycemia, heart issues, kidney failure, liver disease, certain infections or cancers, pregnant women or those not using contraception.Check my eligibility
What is being tested?
The trial is testing if adding dapagliflozin to semaglutide and insulin (triple therapy) better controls blood sugar in Type 1 Diabetes than just semaglutide and insulin (dual therapy) or insulin alone. Participants will receive one of these combinations to compare effectiveness.See study design
What are the potential side effects?
Possible side effects include dehydration leading to low blood pressure, urinary tract infections due to dapagliflozin; nausea from semaglutide; and both may cause changes in cholesterol levels. Insulin can cause low blood sugar episodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I take at least 0.5 U/kg of insulin for multiple daily injections or 0.4 U/kg for pump therapy.
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I have had Type 1 Diabetes for over a year and use an insulin pump or take four or more insulin shots daily.
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I check my blood sugar levels at least four times a day.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c following dapagliflozin
Secondary outcome measures
Assessment of hyperglycemia level 1
Assessment of hyperglycemia level 2
Assessment of hypoglycemia
+19 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Triple therapyExperimental Treatment3 Interventions
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
Group II: Dual TherapyExperimental Treatment2 Interventions
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.
Group III: ControlActive Control1 Intervention
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.
Group IV: Triple therapy controlPlacebo Group3 Interventions
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)).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
Semaglutide
FDA approved
Insulin human
FDA approved

Find a Location

Who is running the clinical trial?

University of GlasgowOTHER
342 Previous Clinical Trials
24,960,948 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
249 Previous Clinical Trials
49,457 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
234 Previous Clinical Trials
142,070 Total Patients Enrolled

Media Library

Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT03899402 — Phase 2 & 3
Type 1 Diabetes Research Study Groups: Triple therapy control, Dual Therapy, Control, Triple therapy
Type 1 Diabetes Clinical Trial 2023: Insulin Highlights & Side Effects. Trial Name: NCT03899402 — Phase 2 & 3
Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03899402 — Phase 2 & 3
~10 spots leftby Dec 2024