Semaglutide + Low-Dose Insulin Glargine for Type 2 Diabetes
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive semaglutide with a lower dose of insulin glargine or a higher dose of insulin glargine alone to control blood glucose levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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)).
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).
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Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
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
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.
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.
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.
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.
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 ...
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.
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 ...
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 ...
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.
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novonordisk-trials.com
novonordisk-trials.com/content/dam/nntrials/global/en/studies/data/4386%20lay%20summary.pdfSUSTAIN 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 ...
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