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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 weeks2 visits

Treatment ~ 40 weeks7 visits

Follow Up ~ 5 weeks1 visit

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%

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

0 / 4Eligibility criteria met