Insulet’s SECURE-T2D Pivotal Trial Results Demonstrate Omnipod® 5 Improves Clinical Outcomes and Quality of Life in Type 2 Diabetes
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.
- 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.
- One occurrence of severe hypoglycemia during the treatment phase.
- 13 serious adverse events, though none were glycemia-related nor related to the trial device.
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
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.
The results of the SECURE-T2D pivotal trial have significant market implications. With over
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.
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
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
“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
As one of the most racially diverse studies in diabetes technology, the data represented 305 participants from 21 sites across the
Key Data Highlights
-
Mean HbA1c (%) was significantly reduced with Omnipod 5, lowering from
8.2% to7.4% , or a reduction of0.8% .-
Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was
2.1% for those with a baseline HbA1c ≥9.0% .
-
Those with a higher baseline HbA1c had a greater decrease: reduction in HbA1c was
-
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, from45% to66% . 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% and2.0% 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
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.
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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
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