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Insulin
Semaglutide + Low-Dose Insulin Glargine for Type 2 Diabetes
Verified Trial
Phase 3
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been using once daily insulin for at least 3 months?
Have you been on a stable dose of metformin for at least 3 months?
Timeline
Screening 2 weeks
Treatment 40 weeks
Follow Up 5 weeks
Awards & highlights
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.
Who is the study for?
This trial is for adults with type 2 diabetes who've been on once-daily insulin for at least 3 months, have a BMI of 25 or more, and stable metformin use. Not eligible if they have unstable diabetic eye disease, severe kidney issues, recent pancreatitis, history of ketoacidosis, unawareness of low blood sugar episodes, or certain other conditions.Check my eligibility
What is being tested?
The study compares semaglutide with a lower dose of insulin glargine versus a higher dose of insulin glargine alone in controlling blood glucose over about 11 months. Participants will be monitored through clinic visits and continuous glucose sensors during the study.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort like nausea or diarrhea (common with semaglutide), low blood sugar events especially when combined with insulin therapy, possible allergic reactions to medication components, and injection site reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been using insulin daily for at least 3 months.
Select...
I have been taking the same dose of metformin for at least 3 months.
Select...
I have had type 2 diabetes for at least 6 months.
Timeline
Screening ~ 2 weeks2 visits
Treatment ~ 40 weeks7 visits
Follow Up ~ 5 weeks1 visit
Screening ~ 2 weeks
Treatment ~ 40 weeks
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
Secondary outcome measures
Change in Body Weight
Change in HbA1c
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
+10 moreSide effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Insuline glargine U100 (reduced) + semaglutideExperimental Treatment2 Interventions
Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).
Group II: Insuline glargine U100 (titrated)Active Control1 Intervention
Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,497 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,257 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been using insulin glargine at 40 units or less daily for over 90 days.I have been using insulin daily for at least 3 months.I have been taking the same dose of metformin for at least 3 months.Is your Body Mass Index (BMI) 25 or higher?I have had type 2 diabetes for at least 6 months.I was diagnosed with Type 2 Diabetes more than 6 months ago.I am taking 1500 mg or more of metformin daily, or the highest dose I can tolerate.
Research Study Groups:
This trial has the following groups:- Group 1: Insuline glargine U100 (titrated)
- Group 2: Insuline glargine U100 (reduced) + semaglutide
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 40 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 5 Weeks after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05514535 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Ohio
Other
Tennessee
How old are they?
18 - 65
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
3+
0
What questions have other patients asked about this trial?
What does the trial do? How long is each visit? How long do screenings take?
PatientReceived 2+ prior treatments
How long does the screening test take? How safe is it and what does it entail?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I need to lose weight. I saw your ad on line. Trying to loose weight. Facebook. Last A1C 6.1.
PatientReceived 2+ prior treatments
My diabetes is out of control.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Novo Nordisk Investigational Site: < 24 hours
Average response time
- < 2 Days
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