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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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I have been using insulin daily for at least 3 months.
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I have been taking the same dose of metformin for at least 3 months.
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I have had type 2 diabetes for at least 6 months.

Timeline

Screening ~ 2 weeks
Treatment ~ 40 weeks
Follow Up ~5 weeks
This trial's timeline: 2 weeks for screening, 40 weeks for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes
Secondary study objectives
Change in Body Weight
Change in HbA1c
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
+10 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2021
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
1,549 Previous Clinical Trials
2,443,464 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
129 Previous Clinical Trials
151,730 Total Patients Enrolled

Media Library

Insuline glargine U100 (reduced) (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05514535 — Phase 3
Type 2 Diabetes Research Study Groups: Insuline glargine U100 (titrated), Insuline glargine U100 (reduced) + semaglutide
Type 2 Diabetes Clinical Trial 2023: Insuline glargine U100 (reduced) Highlights & Side Effects. Trial Name: NCT05514535 — Phase 3
Insuline glargine U100 (reduced) (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514535 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05514535 — Phase 3
~0 spots leftby Nov 2024
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