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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 belowSelect...
I take at least 0.5 U/kg of insulin for multiple daily injections or 0.4 U/kg for pump therapy.
Select...
I have had Type 1 Diabetes for over a year and use an insulin pump or take four or more insulin shots daily.
Select...
I check my blood sugar levels at least four times a day.
Select...
I am between 18 and 70 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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 moreTrial 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
337 Previous Clinical Trials
24,959,016 Total Patients Enrolled
State University of New York at BuffaloLead Sponsor
246 Previous Clinical Trials
49,394 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
232 Previous Clinical Trials
141,670 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diabetes or chronic pancreatitis recently or have MODY.I had weight loss surgery within the last year.I haven't used diabetes medication other than insulin in the last 3 months.I take at least 0.5 U/kg of insulin for multiple daily injections or 0.4 U/kg for pump therapy.You are currently on a weight loss program or doing intense exercise to lose weight.I have had pancreatitis before.I have had Type 1 Diabetes for over a year and use an insulin pump or take four or more insulin shots daily.My diabetes symptoms are not well-managed.Your C-peptide level is lower than 0.23 nM.My liver isn't working well, with high AST or ALT levels.I have a history of delayed stomach emptying.Your HbA1c level is higher than 7.5%.I've had more than one severe low blood sugar episode needing medical help in the last month.I am not pregnant, using reliable birth control, or breastfeeding.My hemoglobin level is below the normal range for my gender.I have blood in my urine that has not been explained.I have low blood volume or chronic kidney problems.You have a problem with drinking too much alcohol.I do not have any severe illnesses other than heart issues.I have had diabetic retinopathy in the past.I am on dialysis or my kidney function is low.I am HIV or Hepatitis B/C positive.I have had a severe diabetes complication needing treatment in the last 3 months.Your blood test shows high levels of bilirubin, unless it's only because of Gilbert's Syndrome.I am unable to understand and give consent for treatment.I check my blood sugar levels at least four times a day.I have painful gallstones.I have a history of diabetes insipidus.I am between 18 and 70 years old.You have had a severe allergic reaction to these medications in the past.I have a cancer other than in situ or basal cell skin cancer.You are knowledgeable about counting carbohydrates.I have had a heart event or procedure in the last 3 months or have congestive heart failure.You weigh more than what is considered healthy for your height.I have a history of Addison's disease or chronic adrenal insufficiency.I have had medullary thyroid cancer or MEN 2 syndrome.Your triglyceride levels are very high, over 500 mg/dl.I have had repeated yeast infections in the genital area.
Research Study Groups:
This trial has the following groups:- Group 1: Triple therapy control
- Group 2: Dual Therapy
- Group 3: Control
- Group 4: Triple therapy
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research include seniors as participants?
"In order to be included in this clinical trial, patients must meet the age requirement of being between 18 and 75 years old. There are currently 183 trials underway for individuals younger than 18 and 353 for seniors aged 65 and up."
Answered by AI
How many individuals are participating in this research trial?
"Yes, the information on clinicaltrials.gov indicates that this trial is actively looking for patients. The trial was first posted on 5/1/2019 and was most recently updated on 9/10/2022. 114 patients are needed across 1 location."
Answered by AI
Are investigators still seeking participants for this experiment?
"That is correct. The listing on clinicaltrials.gov says that this study, which was originally published on May 1st 2019, is still recruiting patients. So far, 114 people have been accepted across 1 centre."
Answered by AI
For what reason is Semaglutide typically prescribed?
"In many cases, chronic weight management is treated with Semaglutide. However, this drug can also help patients that are type 1 diabetic and struggling with calorie restriction or lack of exercise."
Answered by AI
Are there any prerequisites for participants of this research?
"This study is currently recruiting 114 individuals aged 18-75 that have diabetes and another autoimmune condition. Furthermore, these patients must measure their blood sugar four or more times a day, have a BMI of at least 25 kg/m2, and have C-peptide levels below 0.23 nM."
Answered by AI
Who else is applying?
What site did they apply to?
Diabetes and Endocrinology Research Center of WNY
What portion of applicants met pre-screening criteria?
Met criteria
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