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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetes or chronic pancreatitis recently or have MODY.

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I haven't used diabetes medication other than insulin in the last 3 months.

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I have had pancreatitis before.

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My diabetes symptoms are not well-managed.

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My liver isn't working well, with high AST or ALT levels.

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I have a history of delayed stomach emptying.

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I've had more than one severe low blood sugar episode needing medical help in the last month.

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I am not pregnant, using reliable birth control, or breastfeeding.

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My hemoglobin level is below the normal range for my gender.

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I have blood in my urine that has not been explained.

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I have low blood volume or chronic kidney problems.

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I do not have any severe illnesses other than heart issues.

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I have had diabetic retinopathy in the past.

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I am on dialysis or my kidney function is low.

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I am HIV or Hepatitis B/C positive.

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I have had a severe diabetes complication needing treatment in the last 3 months.

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I am unable to understand and give consent for treatment.

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I have painful gallstones.

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I have a history of diabetes insipidus.

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I have a cancer other than in situ or basal cell skin cancer.

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I have had a heart event or procedure in the last 3 months or have congestive heart failure.

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I have a history of Addison's disease or chronic adrenal insufficiency.

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I have had medullary thyroid cancer or MEN 2 syndrome.

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I have had repeated yeast infections in the genital area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in HbA1c following dapagliflozin

Secondary study objectives

Assessment of hyperglycemia level 1

Assessment of hyperglycemia level 2

Assessment of hypoglycemia

+19 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 28Eligibility criteria met