Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes

Rhea-AI Summary

Insulet (NASDAQ: PODD) announced positive results from its SECURE-T2D pivotal trial at the ADA 84th Scientific Sessions. The trial, the largest and most diverse study of automated insulin delivery (AID) in type 2 diabetes, highlighted significant improvements with the Omnipod 5 system. The results showed a 0.8% reduction in HbA1c overall, with a 2.1% decrease for those with baseline HbA1c ≥9.0%. Time in range increased by 20%, and total daily insulin dose decreased by 23 U/day. There were no significant hypoglycemia risks. The study included 305 participants, with 24% Black and 22% Hispanic representation, aiming for FDA approval for use in type 2 diabetes by early 2025.

Positive

• 0.8% reduction in mean HbA1c, with higher reductions for baseline HbA1c ≥9.0%.
• 20% increase in time in range (4.8 hours/day).
• Reduction in total daily insulin dose by 23 U/day.
• No significant increase in hypoglycemia risk.
• 305 participants with diverse representation: 24% Black and 22% Hispanic.
• Omnipod 5 shown to improve diabetes distress.
• Expected FDA clearance for type 2 diabetes by early 2025.

Negative

• One occurrence of severe hypoglycemia during the treatment phase.
• 13 serious adverse events, though none were glycemia-related nor related to the trial device.

Medical Research Analyst

The positive results of the SECURE-T2D pivotal trial for Insulet's Omnipod 5 reveal significant clinical improvements in managing type 2 diabetes. The reduction in HbA1c by 0.8% is notable, with those having a higher baseline HbA1c experiencing even greater reductions. The improvement in time in range (TIR) by 20% further underscores the efficacy of automated insulin delivery (AID) in maintaining better glucose control. Importantly, these improvements were achieved without an increase in hypoglycemia, which is a critical safety consideration.

Another key aspect is the diversity of the study’s participants, which enhances the generalizability of the findings. Black and Hispanic populations, who are disproportionately affected by type 2 diabetes, showed similar benefits, suggesting broad applicability of this technology across different demographics.

Market Research Analyst

The results of the SECURE-T2D pivotal trial have significant market implications. With over 30 million people living with type 2 diabetes in the U.S. and no FDA-cleared AID systems currently available for this population, these findings position Insulet's Omnipod 5 as a potentially groundbreaking product. The anticipated FDA approval could open up a substantial new market segment, potentially driving the company's revenue growth.

Additionally, the study’s success in diverse populations can enhance the market acceptance and adoption of the product. Insulet's strategic submission for FDA clearance by early 2025 aligns with a timely market entry, potentially giving it a competitive advantage.

Financial Analyst

The positive outcomes from the SECURE-T2D pivotal trial are a potential catalyst for Insulet's stock (NASDAQ: PODD). Investors should note the significant improvements in clinical endpoints like HbA1c reduction and TIR increase, which could drive strong demand upon FDA clearance. The expansion into the type 2 diabetes market could significantly boost Insulet's revenues, given the large patient population and unmet need for AID systems.

Long-term, the success of Omnipod 5 in type 2 diabetes management could enhance Insulet’s market position and lead to sustained growth. However, investors should closely monitor the FDA approval process and subsequent commercial performance to gauge the full financial impact.

Largest, longest, and most racially diverse study of automated insulin delivery (AID) conducted in people with type 2 diabetes to date

ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod^® brand of products, today shared positive results from its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) type 2 diabetes pivotal trial at the American Diabetes Association (ADA) 84th Scientific Sessions in Orlando, Florida. This landmark study evaluated the impact of AID in a diverse group of people with type 2 diabetes who require insulin.

The SECURE-T2D pivotal trial results showed glycemic improvements with the use of Omnipod 5 compared with prior treatment of insulin injections or pump therapy in adults with type 2 diabetes. The study results showed significant reductions in HbA1c, time in hyperglycemia, and total daily insulin dose, and a large improvement in time in range (TIR), without increasing time in hypoglycemia. The study also demonstrated a clinically meaningful improvement in diabetes distress.

“These data demonstrate that simple, easy-to-use AID technology, such as Omnipod 5, can be adopted by a broad population of people with type 2 diabetes and improve their lives,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director. “A major strength of this study is the diversity of the enrolled population in terms of varying education level, income, ethnicity, and race. These results could have a particularly striking impact among Black and Hispanic people, who experience a higher prevalence of type 2 diabetes and increased mortality rates.”

Even though over 30 million people live with type 2 diabetes in the United States,¹ there are no AID systems currently FDA-cleared for this population. Insulet recently submitted these study results to the FDA for an expansion of Omnipod 5’s indications for use for people with type 2 diabetes and, subject to FDA clearance, expects to commercially launch in the U.S. in early 2025. Omnipod 5 is currently FDA-cleared in the U.S. and C.E. marked for use in those with type 1 diabetes aged two years and older.

“Our findings demonstrate substantial improvements in blood glucose outcomes and overall quality of life, highlighting the potential for this innovative technology to transform type 2 diabetes management with automated insulin delivery,” said Dr. Francisco Pasquel, MD, MPH of Emory University and chair of the study. “As the largest study of AID therapy in people with type 2 diabetes, we look forward to these results supporting the FDA clearance of Omnipod 5 as a safe and effective therapy for this patient population.”

Study Overview

The primary objective of the SECURE-T2D Pivotal Trial was to evaluate change in HbA1c with Omnipod 5 in adults aged 18-75 years, living with type 2 diabetes with a current insulin regimen for at least three months. Other criteria included a baseline HbA1c between 7% and 12% for those using basal insulin only, and 12% or less for those using basal and bolus or pre-mixed insulin. Secondary objectives included demonstrating improvements in time in range, and time in hyperglycemia, as well as demonstrating non-inferiority for hypoglycemia. Additionally assessed as a secondary objective was diabetes distress, a patient-reported outcome.

As one of the most racially diverse studies in diabetes technology, the data represented 305 participants from 21 sites across the U.S., including 24% Black and 22% Hispanic participants. More than half (55%) were on a stable dose of GLP-1 receptor agonists, and 73% used multiple daily injections of insulin, while 21% used basal-only insulin at baseline, and only 5.6% used an insulin pump at baseline. After an initial 14 days of standard therapy, the study participants used the Omnipod 5 AID system for 13 weeks. They could eat and exercise with no restrictions and were given the option to bolus for blood glucose corrections only, for actual carbohydrate intake, or for a set carbohydrate regimen.

Key Data Highlights

• Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from 8.2% to 7.4%, or a reduction of 0.8%.
  • Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was 2.1% for those with a baseline HbA1c ≥9.0%.
• Significant improvements for HbA1c were observed regardless of prior therapy at the start of the trial, including:
  • Multiple daily injections and in those transitioning from basal-only insulin therapy
  • GLP-1 users and non-GLP-1 users, suggesting that adults with type 2 diabetes who require insulin therapy can greatly benefit from AID regardless of whether they are already using other glucose-lowering medication
  • Current users or non-users of continuous glucose monitoring (CGM), suggesting an added benefit of AID in type 2 diabetes beyond the glycemic benefit observed with CGM use
• Time in range significantly improved with Omnipod 5, increasing by 20%, or 4.8 hours/day, from 45% to 66%. This finding was driven by reductions in hyperglycemia levels including time above 180, 250 and 300 mg/dL.
• Time below 54 mg/dL (%) and time below 70 mg/dL (%) were shown to be non-inferior (within a 0.5% and 2.0% margin, respectively), demonstrating that improving glycemic control with Omnipod 5 did not increase hypoglycemia risk.
• Additional outcomes analysis showed that the amount of insulin used was reduced from an average of 0.80 U/kg/day during standard therapy to 0.57 U/kg/day during AID. This corresponds to an average decrease of 23 U/day.
• As reported by patients through individual surveys (T2-DDAS), there was a significant and clinically meaningful improvement in diabetes distress: the percentage of participants with high diabetes distress (T2-DDAS total score ≥2.0) was significantly reduced.
• There were no instances of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS). There was one occurrence of severe hypoglycemia during the treatment phase, deemed unrelated to trial device malfunction. There were 13 additional serious adverse events, but none were glycemia-related nor related to the trial device.

The SECURE-T2D pivotal trial data will be discussed in several events at ADA this weekend, including:

Saturday, June 22, 2024, 12:30 – 1:30 p.m. ET (Poster Hall)

Poster Presentation: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr. Francisco Pasquel

Sunday, June 23, 2024, 10:15 – 11:00 a.m. ET (Product Theater #1)

Insulet Product Theater: Omnipod 5: Advancing Automated Insulin Delivery for All with Francisco Pasquel, Dr. Gregory Forlenza, and Dr. Trang Ly

Sunday, June 23, 2024, 1:50 – 2:00 p.m. ET (ePoster Theater A)

ePoster Theater: 1904-LB Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes — Results of the SECURE-T2D Pivotal Trial with Dr. Francisco Pasquel

Analysis of GLP-1 and Insulin Use in Type 2 Diabetes

Separately, Insulet also partnered with Optum^® Health Economics and Outcomes Research to conduct a retrospective, real-world analysis of GLP-1 and non-GLP-1 patient cohorts. This analysis demonstrates that GLP-1s are additive to the treatment paradigm in type 2 diabetes. Patients who adopt GLP-1 therapy are twice as likely to initiate insulin therapy within 12 months. To learn more, read the Market Opportunity & Impact of GLP-1s.

¹National Diabetes Statistics Report: https://www.cdc.gov/diabetes/php/data-research/

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

Forward-Looking Statement:

This press release may contain forward-looking statements concerning Insulet's expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 23, 2024 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary materially from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.

©2024 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation. All rights reserved. All other trademarks are the property of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240621869326/en/

Investor Relations:

Deborah R. Gordon

Vice President, Investor Relations

(978) 600-7717

dgordon@insulet.com

Media:

Angela Geryak Wiczek

Senior Director, Corporate Communications

(978) 932-0611

awiczek@insulet.com

Source: Insulet Corporation

FAQ

What were the key findings of Insulet's SECURE-T2D pivotal trial?

The SECURE-T2D pivotal trial showed a 0.8% reduction in mean HbA1c, a 20% increase in time in range, and a reduction in total daily insulin dose by 23 U/day with the use of the Omnipod 5 system.

How did the Omnipod 5 system perform in reducing HbA1c levels?

The Omnipod 5 system reduced mean HbA1c levels by 0.8%, with those having a baseline HbA1c of ≥9.0% seeing a reduction of 2.1%.

Was there any improvement in time in range with the Omnipod 5 system in the SECURE-T2D trial?

Yes, the time in range increased by 20%, or 4.8 hours per day, with the Omnipod 5 system.

Did the SECURE-T2D trial report any significant adverse events?

The trial reported one occurrence of severe hypoglycemia and 13 other serious adverse events, none of which were glycemia-related or related to the trial device.

What is the expected timeline for FDA clearance of Omnipod 5 for type 2 diabetes?

Insulet expects FDA clearance for the Omnipod 5 system for use in type 2 diabetes by early 2025, following the results of the SECURE-T2D trial.