INHALE-3 Study's Initial Meal Challenge Results Comparing Afrezza Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps
INHALE-3 Study's Initial Meal Challenge Results Comparing Afrezza Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps
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Post-meal hyperglycemia was significantly reduced by 20% with inhaled insulin compared with rapid-acting insulin delivered through MDI or insulin pumps
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Subjects utilizing inhaled insulin experienced a 22% decrease in mean glucose excursions in the first two hours compared to the standard of care
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17-week primary endpoint results will be presented during a 90-minute symposium at the American Diabetes Association's Scientific Sessions in June
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與通過 MDI 或胰島素泵輸送的速效胰島素相比,吸入胰島素的餐後高血糖顯著降低 20%
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與標準護理相比,使用吸入胰島素的受試者在最初兩個小時內的平均血糖偏移減少了22%
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爲期17周的主要終點結果將在6月的美國糖尿病協會科學會議上舉行的90分鐘研討會上公佈
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced initial meal challenge data from INHALE-3 that was presented by Dr. Irl B. Hirsch at the 17thInternational Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 8th. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
康涅狄格州丹伯裏和加利福尼亞州西湖村,2024 年 3 月 11 日(GLOBE NEWSWIRE)——專注於爲內分泌和孤兒肺病患者開發和商業化的吸入治療產品和設備的公司 MannKind Corporation(納斯達克股票代碼:MNKD)公佈了 Irl B. Hirsch 博士在 17 日發佈的 INHALE-3 的初步膳食挑戰數據第四3月8日在佛羅倫薩舉行的糖尿病先進技術和治療國際會議(ATTD)第四。INHALE-3 是一項評估吸入胰島素(加基礎胰島素)與標準護理的美國四期臨床試驗。
The statistically significant findings included:
具有統計意義的發現包括:
- Subjects utilizing inhaled insulin experienced significantly reduced post-meal hyperglycemia, compared with those who used subcutaneous rapid-acting analogues (RAA) delivered by MDI or pumps
- Area under the curve (AUC; 180 mg/dL) was reduced by 20%
- Inhaled insulin subjects demonstrated significantly lower glucose excursions from baseline
- Mean glucose excursions were reduced by 22%
- In the inhaled insulin group, mean glucose levels peaked 15 minutes sooner than in the standard of care group despite inhaled insulin being given at start of the meal vs. RAA being administered 5-15 minutes prior to the meal
- 與使用由MDI或泵輸送的皮下速效類似物(RAA)的受試者相比,使用吸入胰島素的受試者餐後高血糖明顯降低
- 曲線下方的面積(AUC;180 mg/dL)減少了 20%
- 吸入胰島素受試者的血糖偏移明顯低於基線
- 平均血糖偏差減少了22%
- 在吸入胰島素組中,儘管在進餐開始時給予吸入性胰島素,但平均血糖水平比標準治療組提前15分鐘達到峯值,而RAA是在進餐前5-15分鐘給藥
"Clinician have been seeking options for people living with diabetes in hopes of identifying treatments that provide improved mealtime control," said Dr. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington and the INHALE-3 Study Protocol Chair. "It is exciting to share data from this study's standardized meal challenge, demonstrating inhaled insulin can help address this unmet need."
華盛頓大學醫學和糖尿病治療教授兼教學主席、INHALE-3 研究方案主席赫****說:“臨床醫生一直在爲糖尿病患者尋找選擇,希望找到能夠改善進餐時間控制的治療方法。”“分享這項研究的標準化膳食挑戰賽的數據令人興奮,表明吸入胰島素可以幫助解決這種未滿足的需求。”
The 17-week endpoint results from INHALE-3 will be presented Saturday, June 22, during a symposium at the American Diabetes Association's 84th Scientific Sessions in Orlando.
INHALE-3 的 17 周終點結果將於 6 月 22 日星期六在美國糖尿病協會 84 的研討會上公佈第四 奧蘭多的科學會議。
"One of the challenges of inhaled insulin adoption has been under-dosing when converting from injectable insulin, which causes patients to experience hyperglycemia," said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. "In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start."
MannKind Corporation臨床開發和醫學事務高級副總裁凱文·凱瑟曼博士說:“採用吸入式胰島素面臨的挑戰之一是從注射胰島素轉換時劑量不足,這會導致患者出現高血糖。”“在這項使用更合適劑量轉換的大型隨機試驗中,我們很高興看到膳食挑戰賽的結果從一開始就支持吸入胰島素的安全性和有效性。”
INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label. Both arms utilized continuous glucose monitoring to assess glucose control. A1c levels were obtained at baseline, 17 and 30-weeks. For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal. More information on the INHALE-3 study is available at: ClinicalTrials.gov(NCT05904743).
INHALE-3 是一項爲期 17 周的隨機對照試驗,延期 13 周。該研究招收了141名患者(123名隨機分組),分配了18歲以上使用MDI、自動胰島素輸送系統或非自動化泵的T1D參與者繼續接受標準護理或啓動胰島素方案,即每日基礎注射加Afrezza進行丸劑(進餐時間和矯正)。使用吸入胰島素的受試者獲得的初始轉換劑量高於當前標籤中的劑量。兩組都使用持續的血糖監測來評估血糖控制情況。A1c水平是在基線、17周和30周時獲得的。對於膳食挑戰,吸入胰島素組在標準膳食(240卡路里的營養奶昔)前立即服用吸入的胰島素劑量,而使用常規護理的患者在餐前5-15分鐘使用RAA。有關 INHALE-3 研究的更多信息,請訪問: ClinicalTrials.gov (NCT05904743)。
About Afrezza
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.
關於 Afrezza
Afrezza(人胰島素)吸入粉是一種速效吸入式人胰島素,適用於改善成年糖尿病患者的血糖控制。
Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.
使用限制:不建議用於治療糖尿病酮症酸中毒或吸菸或最近戒菸的患者。
Important Safety Information
重要安全信息
WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE | |
• | Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPD |
• | Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD |
• | Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. |
警告:慢性肺病患者出現急性支氣管痙攣的風險 | |
• | 在 Afrezza 治療的哮喘和慢性阻塞性肺病患者中已觀察到急性支氣管痙攣 |
• | 哮喘或慢性阻塞性肺病等慢性肺病患者禁用 Afrezza |
• | 在啓動 Afrezza 之前,請進行詳細的病史、體格檢查和肺活量測定 (FEV)1)以確定所有患者的潛在肺部疾病。 |
Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
最常見的不良反應是低血糖、咳嗽和喉嚨痛或刺激。
Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety.
請參閱其他重要安全信息、完整處方信息,包括方框警告,可在上找到 afrezza.com/安全。
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
關於 MannKind
MannKind Corporation(納斯達克股票代碼:MNKD)專注於創新治療產品和設備的開發和商業化,以滿足內分泌和孤兒肺病患者嚴重未得到滿足的醫療需求。
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.
我們致力於利用我們的配方能力和設備工程實力來減輕糖尿病、肺動脈高壓 (PAH) 和非結核分枝桿菌 (NTM) 肺部疾病等疾病的負擔。我們的標誌性技術——乾粉配方和吸入設備——可快速便捷地將藥物輸送到深肺,在那裏藥物可以在局部發揮作用或進入體循環。
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
我們擁有一支充滿激情的 Mannitarians 團隊在全國範圍內開展合作,我們的使命是讓人們控制自己的健康和自由生活。
Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, Twitter or Instagram.
請訪問 mannkindcorp.com 了解更多信息,並關注我們 領英, Facebook, 推特 要麼 Instagram。
Forward-Looking Statements
This press release contains forward-looking statements about the planned release of results from an ongoing clinical study that involves risks and uncertainties. Words such as "believes", "anticipates", "plans", "expects", "intends", "will", "goal", "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that we may not achieve our projected development goals in the timeframes we expect, as well as other risks detailed in MannKind's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
前瞻性陳述
本新聞稿包含有關計劃發佈的正在進行的臨床研究結果的前瞻性陳述,該研究涉及風險和不確定性。諸如 “相信”、“預期”、“計劃”、“期望”、“打算”、“將”、“目標”、“潛力” 等詞語以及類似的表述旨在識別前瞻性陳述。這些前瞻性陳述基於MannKind當前的預期。由於各種風險和不確定性,實際業績和事件發生時間可能與此類前瞻性陳述中的預期存在重大差異,其中包括但不限於我們可能無法在預期的時間範圍內實現預期發展目標的風險,以及曼金德向美國證券交易委員會提交的文件(包括截至2023年12月31日止年度的10-K表年度報告以及隨後的10-Q表定期報告)中詳述的其他風險以及表格 8-K 的最新報告。提醒您不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本新聞稿發佈之日。所有前瞻性陳述均受本警示聲明的全部限制,MannKind沒有義務修改或更新任何前瞻性陳述以反映本新聞稿發佈之日之後的事件或情況。
AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.
AFREZZA 和 MANNKIND 是 MannKind 公司的註冊商標。
For MannKind: Christie Iacangelo, Corporate Communications (818) 292-3500 Email: media@mannkindcorp.com Rose Alinaya, Investor Relations (818) 661-5000 Email: ir@mannkindcorp.com
For mannKind:克里斯蒂·艾坎傑洛,企業傳播 (818) 292-3500 電子郵件: media@mannkindcorp.com Rose Alinaya,投資者關係 (818) 661-5000 電子郵件: ir@mannkindcorp.com
Source: MannKind
資料來源:mannKind
譯文內容由第三人軟體翻譯。