Verified

Semaglutide for Obesity

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novo Nordisk Investigational Site, Saint George, UTObesity+1 MoreSemaglutide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial compares semaglutide with insulin glargine in people with type 2 diabetes, looking at how well they control blood sugar levels. Participants will take one medicine or the other for 47 weeks and have 9 clinic visits, 15 phone/video calls, and 1 home visit. They will also wear a sensor measuring blood sugar for 2 periods of 10 days.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: At end of treatment (week 40)

Week 40
Hypoglycemia
Participants Achieving: HbA1c less than 7 Percentage (Yes/No)
Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)
Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
Week 40
Change in Body Weight
Body Weight Changes
Change in HbA1c
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3)
Number of Severe Hypoglycaemic Episodes (Level 3)
Insulin

Trial Safety

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

4 Treatment Groups

Insuline glargine U100 (titrated)
1 of 4
Insuline glargine (titrated)
1 of 4
Insuline glargine U100 (reduced) + semaglutide
1 of 4
Insuline glargine (reduced) + semaglutide
1 of 4

Active Control

Experimental Treatment

568 Total Participants · 4 Treatment Groups

Primary Treatment: Semaglutide · No Placebo Group · Phase 3

Insuline glargine U100 (reduced) + semaglutideExperimental Group · 2 Interventions: Insuline glargine U100 (reduced), Semaglutide · Intervention Types: Drug, Drug
Insuline glargine (reduced) + semaglutideExperimental Group · 2 Interventions: Insuline glargine (reduced), Semaglutide · Intervention Types: Drug, Drug
Insuline glargine U100 (titrated)
Drug
ActiveComparator Group · 1 Intervention: Insuline glargine U100 (titrated) · Intervention Types: Drug
Insuline glargine (titrated)
Drug
ActiveComparator Group · 1 Intervention: Insuline glargine (titrated) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5560

Trial Logistics

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Trial Timeline

Screening: 2 Weeks
Treatment: 40 Weeks
Reporting: 5 Weeks

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,424 Previous Clinical Trials
2,313,100 Total Patients Enrolled
120 Trials studying Obesity
127,436 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
73,260 Total Patients Enrolled
13 Trials studying Obesity
40,333 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Have you been on a stable dose of metformin for at least 3 months?
Have you been using once daily insulin for at least 3 months?
Have you had type 2 diabetes for at least 6 months?
Is your Body Mass Index (BMI) 25 or higher?

Who else is applying?

What state do they live in?
Tennessee65.6%
Ohio9.4%
Texas6.3%
Other18.8%
How old are they?
18 - 65100.0%
What site did they apply to?
Novo Nordisk Investigational Site81.8%
Other18.2%
What portion of applicants met pre-screening criteria?
Did not meet criteria76.7%
Met criteria23.3%
How many prior treatments have patients received?
056.5%
18.7%
28.7%
3+26.1%
Why did patients apply to this trial?
  • "Trying to get my diabetes under control."
  • "I want to get my type 2 diabetes under control and lower my A1C"
  • "I am also on Trulicity. I really have to loose some weight. I need help."
  • "Have prediabetes. Father died at 48 yrs. Old from diabetes complications"
  • "I’m tired of having diabetes and the complications that come along with it."
What questions have other patients asked about this trial?
  • "What does the trial do?"

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Typically responds via
Phone Call71.4%
Email28.6%

Frequently Asked Questions

Has Semaglutide been given the green light by the FDA?

"Semaglutide was given a 3 because, although it is only in Phase 3 trials, there is already some data supporting its efficacy and multiple rounds of data suggesting that it is safe." - Anonymous Online Contributor

Unverified Answer

Are people with the disease currently being accepted into this trial?

"Correct, the listing on clinicaltrials.gov indicates that this trial is still recruiting patients. The study was first posted on 8/29/2022 and edited for the last time on 11/10/2022. In total, 568 participants are needed from 49 different locations." - Anonymous Online Contributor

Unverified Answer

Are there a significant number of hospitals conducting this trial across North America?

"Currently, this study is being conducted in 49 different centres, which are situated in cities such as Chicago, Los Angeles and West Hills. To make the process more convenient for patients, it is advised to select a clinical trial site that is located near you." - 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.