Semaglutide + Low-Dose Insulin Glargine for Type 2 Diabetes

No longer recruiting at 301 trial locations

Overseen By Novo Nordisk

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Metformin, Basal insulin

Disqualifiers: Uncontrolled retinopathy, Type 1 diabetes, Pancreatitis, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 40 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of medications to manage blood sugar levels in people with type 2 diabetes. It compares semaglutide (a medication that improves blood sugar control) combined with a lower dose of insulin glargine against a higher dose of insulin glargine alone. Participants will wear a sensor to monitor their blood sugar and can expect some clinic visits and phone calls over 11 months. Suitable candidates have type 2 diabetes, have managed it for at least six months, take certain diabetes medications, and use a daily insulin dose of 40 units or less. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking diabetes treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should have a stable dose of certain diabetes medications for at least 90 days before screening, so you might be able to continue them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide, when combined with a lower dose of insulin glargine, is generally safe for people with type 2 diabetes. Studies have found that semaglutide causes fewer low blood sugar episodes compared to higher doses of insulin glargine, suggesting it might be safer for controlling blood sugar levels.

Additionally, people taking semaglutide often lose weight, which can be a beneficial side effect for those with type 2 diabetes. The risk of serious side effects with semaglutide appears low, making it a promising choice for many patients.

In summary, using semaglutide with a reduced dose of insulin glargine seems to be a safe and effective way to manage diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for type 2 diabetes?

Researchers are excited about combining semaglutide with low-dose insulin glargine for Type 2 diabetes because it offers a potentially more effective management strategy. Unlike standard treatments that focus solely on blood sugar control through insulin adjustments, semaglutide is a GLP-1 receptor agonist, which not only helps regulate blood sugar but may also contribute to weight loss and improved heart health. This dual approach, combining semaglutide's unique action with a tailored insulin regimen, might enhance overall diabetes care by optimizing glucose control with fewer insulin doses and added health benefits.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

In this trial, participants will receive either semaglutide with a reduced dose of insulin glargine or titrated insulin glargine alone. Research has shown that semaglutide, when combined with a lower dose of insulin glargine, effectively manages type 2 diabetes. Studies have found that semaglutide lowers HbA1c levels, a measure of blood sugar control, and aids in weight loss. It also reduces the risk of major heart problems in people with diabetes. Semaglutide is generally well-tolerated and positively impacts heart and kidney health. These findings suggest that using semaglutide with less insulin glargine could improve blood sugar management in type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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?

Exclusion Criteria

I have been using insulin glargine at 40 units or less daily for over 90 days.

Glycated haemoglobin (HbA1c) of 7-9 percentage [(53-75 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening.

I was diagnosed with Type 2 Diabetes more than 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide with a lower dose of insulin glargine or a higher dose of insulin glargine alone to control blood glucose levels

40 weeks

9 clinic visits, 15 phone/video calls, 1 home visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-7 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insuline glargine (reduced)
• Insuline glargine (titrated)
• Insuline glargine U100 (reduced)
• Insuline glargine U100 (titrated)
• Semaglutide

Trial Overview 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.

How Is the Trial Designed?

Group I: Insuline glargine U100 (reduced) + semaglutide Experimental Treatment 2 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 Control 1 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).

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9889982/

Real world effectiveness of subcutaneous semaglutide in ... The study highlighted benefits of semaglutide on metabolic control, multiple CV risk factors, and renal safety in the real-world.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39248157/

Semaglutide use in people with obesity and type 2 diabetes ... This real-world data analysis showed that semaglutide was well tolerated and that, for a large population, it effectively reduced BMI, body weight and HbA1c.

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes.

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15911

Semaglutide use in people with obesity and type 2 diabetes ... This real-world data analysis showed that semaglutide was well tolerated and that, for a large population, it effectively reduced BMI, body weight and HbA1c.

5. nature.com nature.com/articles/s41591-024-02996-7

Long-term weight loss effects of semaglutide in obesity ... In the SELECT cardiovascular outcomes trial, semaglutide showed a 20% reduction in major adverse cardiovascular events in 17,604 adults with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05514535

A Research Study to Look Into How Semaglutide, Together ... This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6231279/

Semaglutide for the Treatment of Type 2 Diabetes Mellitus By 7 months, both doses of semaglutide significantly reduced the mean HbA1c and body weight as compared with insulin glargine U100; however, the ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858717300852

Efficacy and safety of once-weekly semaglutide versus ... Compared with insulin glargine, semaglutide resulted in greater reductions in HbA1c and weight, with fewer hypoglycaemic episodes, and was well tolerated, with ...

9. withpower.com withpower.com/trial/phase-3-obesity-8-2022-a9d06

Semaglutide + Low-Dose Insulin Glargine for Type 2 ... This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes.

10. novonordisk-trials.com novonordisk-trials.com/content/dam/nntrials/global/en/studies/data/4386%20lay%20summary.pdf

SUSTAIN 11 They also found that less people had episodes of low blood sugar with semaglutide than with insulin aspart, and that people typically lost weight with ...