Breakthrough Clinical Results
Medtronic plc announced that its planned new diabetes company, resulting from an intended separation, will be named MiniMed. This name honors the company's original name and its 40-year history in diabetes care. The new company's mission is to make diabetes more predictable, improving the lives of those affected. The separation is expected to be completed within 18 months, subject to various conditions. MiniMed's products, such as the MiniMed™ 780G system, aim to reduce the burden of diabetes management and improve Time in Range.
Key Highlights
- MiniMed will be the name of Medtronic's planned new diabetes company.
- The company's mission is to make diabetes more predictable.
- The separation from Medtronic is expected within 18 months.
- MiniMed™ 780G system is highlighted as a key product.
Incidence and Prevalence
Global Diabetes Burden (2019-2045):
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2019:
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Prevalence: 9.3% (463 million people)
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Impaired Glucose Tolerance: 7.5% (374 million)
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2030 Projection:
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Prevalence: 10.2% (578 million)
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Impaired Glucose Tolerance: 8.0% (454 million)
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2045 Projection:
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Prevalence: 10.9% (700 million)
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Impaired Glucose Tolerance: 8.6% (548 million)
Key Observations:
- Almost half a billion people live with diabetes globally.
- The number of people with diabetes is projected to increase by 25% in 2030 and 51% in 2045.
- 50.1% of individuals with diabetes are undiagnosed.
- Prevalence is higher in urban areas (10.8%) compared to rural areas (7.2%).
- High-income countries have a higher prevalence (10.4%) than low-income countries (4.0%).
Diabetes Burden in 2019:
- Incidence: 22,239,396 cases (95% UI: 20,599,519-24,058,945)
- Prevalence: 459,875,371 cases (95% UI: 423,474,244-497,980,624)
- Deaths: 1,551,170 cases (95% UI: 1,445,555-1,650,675)
- Disability-Adjusted Life Years (DALYs): 70,880,155 cases (95% UI: 59,707,574-84,174,005)
Additional Insights:
- The burden of diabetes is lower in females than males and increases with age.
- Type 2 diabetes contributes a larger disease burden than Type 1.
- The burden varies across socio-demographic regions and countries.
- The global disease burden of diabetes has increased significantly over the past 30 years and is projected to continue increasing.
Diabetes Burden Attributable to Low Physical Activity (2021):
- Deaths: Approximately 0.15 million
- DALYs: Approximately 5.52 million
- These figures have more than doubled since 1990.
- The age group over 60 has the highest DALY rate.
- The 25-44 age group shows the largest increase between 1990 and 2021.
Note: These statistics represent the latest available data from the provided PubMed articles, primarily focusing on the years 2019 and 2021.
Completion Rate of Trials
Completion Rates for Diabetes Trials (Past 10 Years):
Determining precise completion rates specifically for diabetes trials within the last 10 years is challenging based on the provided abstracts. The abstracts offer broader insights into trial completion rates across various diseases and timeframes, but lack specific data for diabetes trials within this timeframe.
- Abstract 1: Analyzes 10,252 Phase III trials over 20 years, finding a median dropout rate of 11% but doesn't specify completion rates by disease.
- Abstract 2: Examines trials registered on ClinicalTrials.gov from 2000-2019, reporting a 54.9% completion rate for all trials but not specifically for diabetes.
- Abstract 11: Focuses on oral semaglutide for type 2 diabetes, with a completion rate ranging from 92.6% to 97.7% across different doses, but this is a single trial and not representative of all diabetes trials.
- Abstract 21: Discusses a type 1 diabetes prevention trial over 9 years that ultimately failed but doesn't provide overall completion rates for diabetes trials.
- Abstract 22: Compares hypoglycemia reporting in real-world data and randomized controlled trials for diabetes but doesn't offer completion rate data.
- Abstract 29: Mentions a type 1 diabetes prevention trial (DPT-1) that failed but doesn't provide completion rate information.
- Abstract 32: Reports on the PIONEER 10 trial for oral semaglutide in Japanese patients with type 2 diabetes, with a 98% completion rate. Again, this is a single trial.
- Abstract 38: Discusses the ADOPT trial for type 2 diabetes, designed for 4 years of treatment and follow-up, but doesn't provide completion rate data.
Most Common Cause of Trial Abandonment:
Pinpointing the single most common cause of trial abandonment across all diabetes studies is difficult with the available information. However, several factors contributing to trial incompletion or discontinuation are highlighted:
- Abstract 3: Identifies accrual and operational difficulties as the top reasons for trial incompletion in neuro-oncology trials.
- Abstract 6: Mentions discontinuation as a source of waste in surgical trials, along with delayed completion and recruiting shortfalls.
- Abstract 12: Notes software incompatibility and patient no-shows as reasons for failure in a mobile video call trial for cancer patients.
- Abstract 17: Attributes lack of completion to accrual and operational difficulties in neuro-oncology trials.
- Abstract 30: Discusses delays in completion of paediatric studies required under the Paediatric Regulation.
While these abstracts don't offer a definitive answer for diabetes trials specifically, they suggest that recruitment challenges, operational issues, and patient factors likely play significant roles in trial abandonment across various disease areas.
The provided text does not contain information about drug approvals specifically for Medtronic plc within the last three years. Therefore, I cannot answer your question about other indications for which Medtronic plc has received drug approvals.
While some of the texts discuss FDA drug approvals in general and across various therapeutic areas like oncology, infections, and central nervous system disorders, none mention specific companies or their drug portfolio, including Medtronic plc. To find this information, you would need to consult other resources such as:
- Medtronic plc's investor relations website: This is often a good source for press releases and news related to product approvals.
- The FDA website: You can search for drug approvals by company name on the FDA's website.
- Pharmaceutical news outlets and databases: Many specialized publications and databases track drug approvals and can be searched by company.
By using these resources, you should be able to find the specific information you are looking for regarding Medtronic plc's recent drug approvals.