Today, we will be looking into the latest research and clinical trials focused on type 1 diabetes in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for type 1 diabetes, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Type 1 Diabetes Clinical Trials!
Quick View Table of Type 1 Diabetes Clinical Trials
Phase 3 Clinical Trials:
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe It Is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
- Sponsor: Bayer
- Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes.
- The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is approved for doctors to prescribe to people with CKD and type 2 diabetes.
- In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured.
- Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with:
- medical problems (also called treatment-emergent adverse events (TEAEs))
- serious TEAEs. An TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important
- higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines.
- The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times.
- The study team will:
- collect blood and urine samples
- check the participants' vital signs such as blood pressure and heart rate
- do a physical examination including height and weight
- check the participants' heart health by using an electrocardiogram (ECG)
- do pregnancy tests in women of childbearing potential
- Interventions:
- Drug: Finerenone
- Other: Placebo
- Primary Outcomes Measures:
- Change in Urinary albumin-to-creatinine ratio (UACR)
- UACR will be assessed by the Central laboratory.
- Time Frame - From baseline up to 6 months
- Change in Urinary albumin-to-creatinine ratio (UACR)
A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy
- Sponsor: Eli Lilly and Company
- The main purpose of this study is to measure the safety and efficacy of insulin efsitora alfa (LY3209590) compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.
- Interventions:
- Drug: Insulin Efsitora Alfa
- Drug: Insulin Degludec
- Primary Outcomes Measures:
- Change from Baseline in Hemoglobin A1c (HbA1c)
- Time Frame - Baseline, Week 26
A Research Study to See How Well the New Weekly Medicine IcoSema, Which Is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes Compared to Weekly Semaglutide (COMBINE 2)
- Sponsor: Novo Nordisk A/S
- This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to semaglutide.
- Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach.
- The study will last for about 1 year and 1 month. Participants will have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
- Interventions:
- Drug: IcoSema
- Drug: Semaglutide 1 mg
- Primary Outcomes Measures:
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)
- Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
- Time Frame - Baseline (week 0), (week 52)
- Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.
- Change From Baseline in Glycosylated Haemoglobin (HbA1c)
A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
- Sponsor: Novo Nordisk A/S
- This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.
- Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.
- The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
- Interventions:
- Drug: insulin icodec
- Drug: insulin degludec
- Drug: insulin aspart
- Primary Outcomes Measures:
- Change in Glycosylated Haemoglobin (HbA1c) at Week 26
- Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.
- Time Frame - Baseline (week 0), week 26
- Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.
- Change in Glycosylated Haemoglobin (HbA1c) at Week 26
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
- Sponsor: Vertex Pharmaceuticals Incorporated
- This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
- Interventions:
- Biological: VX-880
- Primary Outcomes Measures:
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
- Time Frame - From VX-880 infusion to end of study (up to 5 years)
- Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs)
- 1 year after achieving insulin independence
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs)
Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)
- Sponsor: Regeneron Pharmaceuticals
- The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.
- The secondary objectives of the study are as follows:
- To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
- To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept
- Interventions:
- Drug: aflibercept
- Drug: High-dose aflibercept
- Primary Outcomes Measures:
- Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48
- Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
- Time Frame - Baseline, Week 48
- Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
- Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes (SURPASS-CVOT)
- Sponsor: Eli Lilly and Company
- The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
- Interventions:
- Drug: Tirzepatide
- Drug: Dulaglutide
- Primary Outcomes Measures:
- Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
- Time to First Occurrence of a component event of MACE-3
- Time Frame - Randomization up to Study Completion (Approximate Maximum 54 Months)
- Time to First Occurrence of a component event of MACE-3
- Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (GEMELLI X)
- Sponsor: Sanofi
- To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine.
- Secondary Objectives:
- To compare the effects of alternating administration of SAR341402 and NovoLog with continuous use of NovoLog on immunogenicity.
- To evaluate the safety of alternating administration of SAR341402 and NovoLog versus continuous use of NovoLog.
- To compare other PK parameters between the two treatment arms (alternating administration of SAR341402 and NovoLog and continuous use of NovoLog).
- Interventions:
- Drug: Insulin Aspart SAR341402
- Drug: Insulin Aspart
- Drug: Insulin glargine U100
- Primary Outcomes Measures:
- TiPharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
- AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog.
- Time Frame - 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112
- AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog.
- TiPharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
Potential Guidelines That May Be Affected Include:
- Diabetes Standards of Care 2025
- American Diabetes Association
- Publication: December 09, 2024
- Treatment of Diabetes in Older Adults
- Endocrine Society
- Publication: March 23, 2019
And there you have it - a roundup of Phase 3 clinical trials for type 1 diabetes as of March 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.
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