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Insulin

Semaglutide for Type 2 Diabetes (TRANSITION-T2D Trial)

Phase 4
Waitlist Available
Led By Kevin Pantalone, DO
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

TRANSITION-T2D Trial Summary

This trial will compare the effects of semaglutide + insulin degludec vs. insulin degludec alone in people with type 2 diabetes who are already taking insulin injections.

Eligible Conditions
  • Type 2 Diabetes

TRANSITION-T2D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

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 ≤ 7.5%
Secondary outcome measures
Hypoglycemic episodes
Mean change from baseline in A1C
Mean diabetes treatment satisfaction
+2 more

TRANSITION-T2D Trial Design

2Treatment groups
Experimental Treatment
Group I: Once-weekly sc semaglutide combined with once-daily insulinExperimental Treatment3 Interventions
Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.
Group II: MDI requiring multiple daily injections of insulinExperimental Treatment2 Interventions
Patients randomized to MDI will be allowed to continue correction rapid-acting insulin, in addition to their prandial doses of rapid-acting insulin, throughout the duration of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Insulin Degludec
2020
Completed Phase 4
~8810
Insulin aspart
2011
Completed Phase 4
~4140

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,498 Total Patients Enrolled
Novo Nordisk A/SIndustry Sponsor
1,515 Previous Clinical Trials
2,415,299 Total Patients Enrolled
Kevin Pantalone, DOPrincipal InvestigatorStaff
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Insulin Degludec (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT04538352 — Phase 4
Type 2 Diabetes Research Study Groups: Once-weekly sc semaglutide combined with once-daily insulin, MDI requiring multiple daily injections of insulin
Type 2 Diabetes Clinical Trial 2023: Insulin Degludec Highlights & Side Effects. Trial Name: NCT04538352 — Phase 4
Insulin Degludec (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538352 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What side effects, if any, have been observed from the use of Semaglutide?

"An analysis conducted by Power assigned Semaglutide a score of 3, as this Phase 4 trial has yielded positive results and the medication is now approved for public use."

Answered by AI

Are there currently any slots available for participation in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this experiment is actively seeking participants and has been listed since 18th of January 2021. Subsequent updates were made on the 18th of July 2022. The research team are looking for 100 volunteers from just one site."

Answered by AI

What medical challenges has Semaglutide been utilized to address?

"Semaglutide has the potential to help patients manage exercise, type 1 diabetes mellitus, and other diseases."

Answered by AI

Is there any precedent for this type of trial?

"Currently, 788 cities and 56 countries host 75 live Semaglutide studies. The first trial for the drug was sponsored by Hamad Medical Corporation in 2016 with 150 participants; since then, there have been 563 additional trials conducted."

Answered by AI

What other research endeavors have been launched regarding Semaglutide?

"Currently, there are 33 Phase 3 trials for Semaglutide being conducted worldwide with a total of 4102 trial sites. Of these studies, 75 remain active and several have been initiated in Herlev, Texas."

Answered by AI

Who is eligible for involvement in this experiment?

"This clinical trial seeks 100 individuals, aged 18 to 75 years old, with type 2 diabetes mellitus. To be eligible for the study one must fulfill a range of criteria including: gender (both men and women), ethnicity (all ethnicities are accepted), language (English-speaking only), A1C ≤ 7.5% on present therapy, therapies involving three or more insulin injections per day—with at least two being prandial/rapid-acting varieties like Insulin Aspart, Glulisine or Lispro; as well as single daily doses of long-acting analogues such as Insulin Glargine U-"

Answered by AI

Are persons aged 75 years or younger being taken into consideration for this experiment?

"This clinical trial is open to patients aged 18-75. There are 205 studies for minors and 1163 trials aimed at those over 65 years old."

Answered by AI

How many individuals are being recruited for participation in this research?

"Affirmative. According to the clinicaltrials.gov webpage, this medical research is recruiting participants as of now - it was initially posted on January 18th 2021 and lastly revised on July 18th 2022. The study requires 100 subjects from a single site."

Answered by AI
~14 spots leftby May 2025