78 Participants Needed

Triple Therapy for Type 1 Diabetes

PD
HG
Overseen ByHusam Ghanim, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: State University of New York at Buffalo
Must be taking: Insulin
Prior Safety DataThis treatment has passed at least one previous human trial

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

HG

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

I take at least 0.5 U/kg of insulin for multiple daily injections or 0.4 U/kg for pump therapy.
I have had Type 1 Diabetes for over a year and use an insulin pump or take four or more insulin shots daily.
Your C-peptide level is lower than 0.23 nM.
See 4 more

Exclusion 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.
See 29 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide and insulin for the first 6 months, with dapagliflozin added for the second 6 months in the triple therapy group

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Dapagliflozin
  • Insulin
  • Placebo to Dapagliflozin
  • Semaglutide
Trial Overview 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.
Participant Groups
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)).

Insulin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Insulin for:
  • Diabetes mellitus
🇺🇸
Approved in United States as Insulin for:
  • Diabetes mellitus
🇨🇦
Approved in Canada as Insulin for:
  • Diabetes mellitus

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+

University of Glasgow

Collaborator

Trials
362
Recruited
24,980,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials
237
Recruited
142,000+

Findings from Research

In a study of 951 severely insulin-resistant type 2 diabetes patients, initiating Humulin R U-500 (U-500R) significantly improved treatment compliance and glycemic control, as evidenced by a reduction in HbA1c from 9.3% to 8.5%.
While U-500R improved overall insulin dosage and patient adherence, there was a modest increase in hypoglycemic events, highlighting the need for careful monitoring during treatment.
Treatment Patterns and Outcomes, Before and After Humulin R U-500 Initiation, Among High-Dose Type 2 Diabetes Mellitus Patients in the United States.Hood, RC., Borra, S., Fan, L., et al.[2022]
Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.
The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.
Semaglutide: First Global Approval.Dhillon, S.[2019]
Insulin remains the primary treatment for type 1 diabetes, but recent advancements in insulin analogues have significantly improved glycemic control and allowed for more physiological basal/bolus insulin regimens.
New basal insulin analogues, such as degludec, pegylated lispro, and glargine U300, have shown improvements in duration of action and reduced risk of hypoglycemia, addressing key challenges in intensive diabetes management.
[New insulin types in type 1 diabetes mellitus].Mesa, J.[2015]

References

Treatment Patterns and Outcomes, Before and After Humulin R U-500 Initiation, Among High-Dose Type 2 Diabetes Mellitus Patients in the United States. [2022]
Semaglutide: First Global Approval. [2019]
[New insulin types in type 1 diabetes mellitus]. [2015]
4.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes]. [2020]
Differences in bioactivity between human insulin and insulin analogues approved for therapeutic use- compilation of reports from the past 20 years. [2021]
A randomized pharmacokinetic and pharmacodynamic trial of two regular human insulins demonstrates bioequivalence in type 1 diabetes and availability of biosimilar insulin may improve access to this medication. [2023]
New Insulin Glargine 300 U/mL for the Treatment of Type 1 and Type 2 Diabetes Mellitus. [2022]
Safety of insulin lispro: pooled data from clinical trials. [2019]
Efficacy and Safety of Basal Analog Regimens in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2020]
Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. [2022]
[The insulin analog, Humalog, in discontinuous: from pharmacology to clinical use]. [2011]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Use of human insulin preparations in the treatment of patients with insulin-dependent diabetes mellitus]. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security