Semaglutide for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetes and Endocrinology Research Center of WNY, Williamsville, NYType 1 DiabetesSemaglutide - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Semaglutide Pen Injector [Ozempic]
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Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy
2
Dapagliflozin 10 MG Oral Tablet

Study Objectives

0 Primary · 13 Secondary · Reporting Duration: 12 months

12 months
Assessment of hyperglycemia level 1
Assessment of hyperglycemia level 2
Assessment of hypoglycemia
Assessment of percent time glucose in range
Blood pressure assessment
Diabetic Ketoacidosis
Fructosamine indices
Insulin requirement indices
Severe hyperglycemia assessment
Severe hypoglycemia assessment
Weekly fasting glucose indices
body weight assessment
6 months
Change in HbA1c

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Semaglutide Pen Injector [Ozempic]
2
Outpatient therapy: 8 weeks of drug therapy with usual treatment + 5 weeks of closed-loop therapy
3
Dapagliflozin 10 MG Oral Tablet

Trial Design

4 Treatment Groups

Control
1 of 4
Dual Therapy
1 of 4
Triple therapy
1 of 4
Triple therapy control
1 of 4

Active Control

Experimental Treatment

Non-Treatment Group

114 Total Participants · 4 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 2 & 3

Dual TherapyExperimental Group · 2 Interventions: Semaglutide, Insulin · Intervention Types: Drug, Drug
Triple therapyExperimental Group · 3 Interventions: Dapagliflozin, Semaglutide, Insulin · Intervention Types: Drug, Drug, Drug
Triple therapy controlPlaceboComparator Group · 3 Interventions: Placebo to Dapagliflozin, Semaglutide, Insulin · Intervention Types: Drug, Drug, Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Insulin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
Semaglutide
FDA approved
Insulin human
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor
221 Previous Clinical Trials
45,504 Total Patients Enrolled
University of GlasgowOTHER
298 Previous Clinical Trials
10,967,064 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
213 Previous Clinical Trials
106,172 Total Patients Enrolled
Husam Ghanim, PhDStudy DirectorState University of NY at Buffalo

Eligibility Criteria

Age 18 - 75 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You understand how to count carbohydrates in your food.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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