Triple Therapy for Type 1 Diabetes
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used any diabetes treatment other than insulin in the last 3 months.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used any diabetes treatment other than insulin in the last 3 months.
What data supports the idea that Triple Therapy for Type 1 Diabetes is an effective treatment?
The available research does not provide specific data on the effectiveness of Triple Therapy for Type 1 Diabetes. The studies focus on different treatments and conditions, such as insulin types for Type 1 Diabetes and semaglutide for Type 2 Diabetes. Without direct evidence from these studies, we cannot conclude the effectiveness of Triple Therapy for Type 1 Diabetes.12345
What evidence supports the effectiveness of the drug combination including Dapagliflozin, Insulin, and Semaglutide for Type 1 Diabetes?
Semaglutide, a component of the treatment, has been shown to lower blood sugar and body weight in patients with type 2 diabetes, which may suggest potential benefits for managing blood sugar in type 1 diabetes as well. Additionally, insulin analogues like those included in the treatment have been shown to improve blood sugar control and reduce the risk of low blood sugar episodes in type 1 diabetes patients.12345
What safety data is available for triple therapy in Type 1 Diabetes?
The safety data for components of the triple therapy, such as insulin and dapagliflozin, is available from various studies. Insulin lispro has a safety profile comparable to regular human insulin, with no significant differences in adverse events or progression of diabetes complications. Insulin glargine 300 U/mL has been evaluated for safety in Type 1 Diabetes. However, specific safety data for the combination of dapagliflozin, insulin, and semaglutide in triple therapy for Type 1 Diabetes is not directly addressed in the provided studies.15678
Is the triple therapy for Type 1 Diabetes safe for humans?
The safety of insulin and its analogues, such as lispro and glargine, has been evaluated in various studies, showing they are generally safe for use in diabetes treatment. However, differences in bioactivity compared to human insulin have been noted, and their clinical significance is still being studied.567910
Is the drug Insulin, Semaglutide a promising treatment for Type 1 Diabetes?
Yes, Insulin, Semaglutide is promising for Type 1 Diabetes. Studies show it improves blood sugar control after meals and reduces the risk of low blood sugar episodes, especially at night. It also helps patients achieve better overall blood sugar levels, making it a favorable option for managing diabetes.4571112
How does the triple therapy for Type 1 Diabetes differ from other drug treatments?
The triple therapy for Type 1 Diabetes combines insulin with semaglutide, which is unique because semaglutide is typically used for Type 2 Diabetes and weight management. This combination aims to improve blood sugar control and reduce the risk of hypoglycemia (low blood sugar) by leveraging the benefits of both insulin and semaglutide.4571112
What is the purpose of this trial?
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.
Research Team
Husam Ghanim, PhD
Principal Investigator
State University of NY at Buffalo
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive semaglutide and insulin for the first 6 months, with dapagliflozin added for the second 6 months in the triple therapy group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dapagliflozin
- Insulin
- Placebo to Dapagliflozin
- Semaglutide
Insulin is already approved in European Union, United States, Canada for the following indications:
- Diabetes mellitus
- Diabetes mellitus
- Diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
University of Glasgow
Collaborator
Juvenile Diabetes Research Foundation
Collaborator