A Phase 2 interventional study of Sotagliflozin and Placebo in Type 1 Diabetes and Heart Failure, sponsored by University of Dundee. Recruiting at 17 sites in United Kingdom. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University of Dundee · Phase 2, Interventional, and Treatment
People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.
BACKGROUND Intensive insulin therapy designed to near-normalize glucose levels in people with type 1 diabetes significantly reduces an individual's risk of long-term micro- and macrovascular complications. Unfortunately, glycaemic targets are not achieved by the majority of people with type 1 diabetes and as such overall life expectancy remains reduced compared to those without type 1 diabetes. Cardiovascular disease remains a major cause of morbidity and mortality in type 1 diabetes. There is growing recognition that heart failure (HF) is an increasing problem in type 1 diabetes. Diabetes itself is an independent risk factor for HF, causing structural and functional cardiac changes that predispose to HF (known as diabetic cardiomyopathy). HF is the end result of many cardiovascular diseases such as hypertension and myocardial infarction, and improved treatments for these conditions and changing demographic trends mean that many more people are surviving longer and developing HF.
HF has a substantial healthcare burden. In the United States (US) and Europe, the prevalence of HF in the general population is around 1-2% - around 6 million adults in the US are estimated to be living with HF currently. In 2014 in the US there were \~1.1 million emergency department visits, 980 000 hospitalizations, and 84 000 deaths with HF as the primary cause, with an estimated cost of \~$11.3 billion (\~$11,500/per patient for each hospitalisation). Despite advances in management of HF over the past 30 years, the incidence of mortality and HF hospitalisation in recent HF clinical trials remained high at \~20-30% over 2 years.
The burden of HF in type 1 diabetes is less well characterised compared to HF in those with type 2 diabetes (and individuals without diabetes), however the data still indicate the substantial nature of this growing problem. One of the largest epidemiological studies was a Scottish national data study of 3.25 million individuals >30 years old, where the crude incidence of HF hospitalisation was over twice that of the population without diabetes. While the crude incidence was less than in type 2 diabetes, type 1 diabetes patients were on average 20 years younger. Despite their younger age, 30-day mortality following HF hospitalisation was higher in individuals with type 1 diabetes after adjustment for age, sex and socioeconomic status, indicating that outcomes are worse in HF patients with type 1 diabetes compared to those with either type 2 diabetes or without diabetes. Data from Scandinavia supports this finding and suggests that the risk of both incident HF and cardiovascular mortality was higher for individuals with type 1 diabetes compared to type 2 diabetes after adjustment for age. The overall prevalence of HF in this study at baseline was 3.1% - extrapolated to the US this would equate to 57,000 of the 1.9 million individuals with type 1 diabetes. A recent meta-analysis of all available data suggested that the incidence of HF was 3.1 times higher in individuals with type 1 diabetes compared to controls (typically the general population). Assuming a 5% incidence of HF hospitalisation/year, HF hospitalizations cost the US healthcare system \~$29 million per year. In summary, these data suggest that not only is HF a significant problem in individuals with type 1 diabetes, but there is evidence of an outcome disparity compared to individuals with type 2 diabetes or those without diabetes.
Although there are some differences (e.g. presentation at a younger age), the pathophysiology of HF in type 1 diabetes is similar to type 2 diabetes. Risk factors are similar (e.g. glycaemic control, coronary artery disease and hypertension), leading to inflammation, endothelial dysfunction, fibrosis, and subsequent diastolic and systolic dysfunction. Given the pathophysiological similarities, there is little to suggest that HF therapies that have shown benefit in individuals with type 2 diabetes (or individuals without diabetes) would not also be efficacious in type 1 diabetes. In all current HF guidelines mainstay HF treatments (renin-angiotensin system blockers, beta-blockers, and mineralocorticoid receptor antagonists) are recommended for all patients with HF regardless of diabetes status.
Sodium-glucose co-transporter inhibitors (SGLTi) were initially developed as oral add-on treatments for glycaemic control in type 2 diabetes. A consistent finding in large cardiovascular outcome trials was a significant \~30% risk reduction in hospitalisation for HF, as well as overall reductions in cardiovascular mortality. Subsequently, SGLTi in addition to guideline-directed HF therapy have been studied in HF patients either with type 2 diabetes or without diabetes and have again shown a consistent benefit compared to placebo, with significant reductions in mortality and HF hospitalisation irrespective of cardiac function left ventricular ejection fraction (LVEF) at baseline without any concerning safety signals. SGLTi also improve HF-related quality of life (QoL) and renal outcomes. This has led to the inclusion of SGLTi in the most recent HF treatment guidelines as a cornerstone of therapy in addition to established pharmacological agents (e.g., renin-angiotensin system inhibitors, beta-blockers and mineralocorticoid receptor antagonists). However, there is one key issue - individuals with type 1 diabetes have been excluded from these HF trials, in part due to concerns around safety. At present there is no evidence to support the use of these life-saving therapies in this population that already has worse outcomes than other groups with HF.
In adult type 1 diabetes, Phase III trials with dapagliflozin, empagliflozin and sotagliflozin have been completed, collectively showing modest benefits of SGLT inhibition in terms of Haemoglobin A1c (HbA1c) reduction, increased time in range, reduced body weight and total insulin dose. However, SGLTi use in type 1 diabetes was also associated with an increased risk of diabetic ketoacidosis (DKA), which has limited their more widespread use in type 1 diabetes.
Sotagliflozin is a dual SGLT1 and 2 inhibitor that is currently approved in the United Kingdom for use in individuals with type 1 diabetes with a body mass index (BMI) of ≥27kg/m2 and taking insulin doses of at least 0.5 units/kg of body weight in patients with inadequate glycaemic control. As with selective SGLT2i, sotagliflozin also improves HF-related outcomes. The key evidence for this comes from two clinical trials. In the Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease (SCORED) trial including 10,584 patients with type 2 diabetes, chronic kidney disease and cardiovascular risk factors, sotagliflozin caused a 26% relative risk reduction in the primary endpoint of cardiovascular death, HF hospitalisation or urgent HF visit compared to placebo. There was also a 33% relative risk reduction in HF hospitalisation or urgent HF visits, figures consistent with other SGLT2i trials.
The second key trial was the Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure (SOLOIST-WHF) trial. In this trial 1,222 patients with type 2 diabetes and a recent HF hospitalisation were randomised to sotagliflozin 200mg once daily (with uptitration to 400mg once daily) or placebo. Patients were included regardless of left ventricular ejection fraction (LVEF) at baseline. The median follow-up duration was 9 months.
Sotagliflozin caused a 33% relative risk reduction in the primary outcome of cardiovascular death, HF hospitalisation or urgent HF visit, with a 36% reduction in HF hospitalisation or urgent HF visits that met statistical significance. Sotagliflozin also significantly improved QoL at 4 months measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Rates of serious adverse events (SAEs) leading to study drug withdrawal were similar in both sotagliflozin and placebo groups, though severe hypoglycaemia was more common with sotagliflozin than placebo (9 individuals vs. 2). There was no significant increase in incidence of DKA with sotagliflozin compared to placebo (2 vs. 4). Taken together, these two trials confirm the benefit of sotagliflozin on HF related outcomes, consistent with selective SGLT2i. Again, individuals with type 1 diabetes were excluded from both of these trials.
In summary, there is significant HF related morbidity and mortality in type 1 diabetes, and outcomes are worse than in HF patients with type 2 diabetes or without diabetes. Oral sotagliflozin 200mg daily is licensed for improving glycaemic control in type 1 diabetes in the UK. Although sotagliflozin improves HF related outcomes and QoL in patients with type 2 diabetes and patients with HF who do not have diabetes, studies are needed to determine whether these benefits might extend to patients with type 1 diabetes and heart failure.
RATIONALE As outlined above, HF is a significant problem in type 1 diabetes, with an estimated prevalence of 3-5%. Outcomes for individuals with type 1 diabetes and HF are worse than in those with type 2 diabetes or without diabetes, with increased mortality and hospitalisation rates. Critically, patients with type 1 diabetes have been excluded from pivotal trials of the latest advance in HF treatment (SGLT2i), potentially exacerbating these outcome disparities further.
The proposed trial will be the first to provide data on the efficacy and safety of sotagliflozin, in patients with type 1 diabetes and HF (regardless of LVEF). If a beneficial signal is found, this would provide strong support for extending the use of sotagliflozin in this group of patients with type 1 diabetes and adoption into clinical guidelines. A multi-centre, double-blind, randomised controlled trial to provide the strongest level of evidence for previous findings of the researchers will be conducted. Importantly, by choosing QoL measured using the KCCQ as the primary endpoint, an outcome that not only correlates strongly with mortality and hospitalisation but is also accepted by the US Food and Drug Administration (FDA) as a valid endpoint for regulatory approval has been selected. The KCCQ is a 23- item self-administered questionnaire that measures the patient's perception of their health status, including HF symptoms, impact on physical and social function, and how their HF impacts their QOL within the preceding 2 weeks. Improvements in KCCQ score map very well to reductions in mortality and hospitalisation and SGLT2i have consistently improved KCCQ scores. A 5-point increase in KCCQ score is traditionally considered clinically meaningful and is associated with a 7% reduction in mortality and HF hospitalisation. Given the prohibitive size of trial that would be required to demonstrate an improvement in mortality or HF hospitalizations with sotagliflozin in type 1 diabetes, the KCCQ represents an ideal endpoint for the trial. The proposed trial has the potential to be a high-impact, practice-changing trial.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 320 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Dundee is the lead sponsor of 113 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of heart failure (HF) or high-risk for HF, defined as any of the following:
NT-proBNP ≥250ng/L for those in atrial fibrillation/flutter, ≥125 ng/L for those in all other rhythms or
Previous HF hospitalisation where HF was documented as the primary cause of hospitalisation and there was a requirement for loop diuretics or Impaired left ventricular (LV) function (i.e. \<50% by any imaging modality) at any time or Preserved LV systolic function (LVEF ≥50%) with left atrial enlargement (2-dimensional measurement of left atrial width ≥3.8cm or left atrial length ≥5.0 cm or left atrial area ≥20cm2 or left atrial volume index >29 ml/m2) within the last 24 months.
or Preserved LV systolic function (LVEF ≥50%) with left ventricular hypertrophy (2-dimensional measurement of end-diastolic interventricular septal diameter ≥1.2cm or end-diastolic left ventricular posterior wall diameter ≥1.2cm) within the last 24 months.
or Preserved LV systolic function (LVEF ≥50%) with diastolic dysfunction (septal e' \<7cm/sec or lateral e' \<10cm/sec or average E/e' ≥15) within the last 24 months.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotagliflozin oral tablet, 200mg once per day for 16 weeks.
Drug: Sotagliflozin
Placebo oral tablet, 200mg once per day for 16 weeks.
Drug: Placebo
Sodium-glucose Co-transporter inhibitor
Matched placebo
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on quality of life (QoL). KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
Time frame: From baseline to week 16
Change in KCCQ clinical summary score
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
Time frame: From baseline to week 4
Change in KCCQ overall summary score
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
Time frame: From baseline to weeks 4 and 16
Proportion of participants with a ≥5, ≥10 and ≥15 point increase in KCCQ clinical and overall summary scores
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. KCCQ clinical summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status). KCCQ overall summary score (no unit, ranges from 0 to 100 with higher scores reflecting better health status).
Time frame: From baseline to week 16
Change in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) and Change (DTSQc)
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. Treatment satisfaction status score (no unit, ranges from 0 to 36, with higher scores reflecting greater treatment satisfaction). Treatment satisfaction change score (no unit, designed to overcome ceiling effects and to detect changes in treatment satisfaction on a scale from -18 to 18 with negative scores reflecting decreased treatment satisfaction, 0 reflecting no change and positive scores reflecting increased treatment satisfaction).
Time frame: From baseline to week 16
Change in EQ-5D-5L questionnaire score
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on QoL. The instrument consists of two components: the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels (level 1 "no problems", level 2 "slight problems", level 3 "moderate problems", level 4 "severe problems", and level 5 "extreme problems"), from which a single EQ-5D index score can be calculated ranging from 0 to 1 where higher scores indicate higher health utility. The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
Time frame: From baseline to week 16
Change in distance covered during 6-minute walk test
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on walking distance
Time frame: From baseline to week 16
Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on NT-proBNP
Time frame: From baseline to week 16
Change in Haemoglobin A1c (HbA1c)
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on glycaemic control
Time frame: From baseline to week 16
Proportion of participants with level 2 or level 3 hypoglycaemia
To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
Time frame: From baseline to weeks 16 and 20
Proportion of participants with diabetic ketoacidosis (DKA)
To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
Time frame: From baseline to weeks 16 and 20
Proportion of participants requiring hospitalisation due to heart failure (HF)
To provide information on safety and tolerability of sotagliflozin 200mg once daily in addition to standard of care compared to placebo
Time frame: From baseline to weeks 16 and 20
Change in New York Heart Association (NYHA) class
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
Time frame: From baseline to weeks 16 and 20
Change in daily loop diuretic dose
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
Time frame: From baseline to week 16
Change in systolic and diastolic blood pressure.
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
Time frame: From baseline to week 16
Number of hospitalizations and deaths (first and total number) due to heart failure
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on HF symptoms, signs and clinical outcomes
Time frame: From baseline to weeks 16 and 20
Change in estimated glomerular filtration rate (eGFR)
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
Time frame: From baseline to week 16
Change in serum creatinine
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
Time frame: From baseline to week 16
Change in urine albumin to creatinine ratio
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on renal parameters
Time frame: From baseline to week 16
Change in total, basal and bolus insulin doses
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
Time frame: From baseline to week 16
Change in in body weight
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on diabetes-related parameters
Time frame: From baseline to week 16
Mean blood glucose level over preceding 14 days
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
Time frame: From baseline to week 16
Blood glucose percentage time in range (3.9-10.0 mmol/L) over preceding 14 days
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
Time frame: From baseline to week 16
Blood glucose percentage time below range (3.0-3.8 mmol/L and <3.0 mmol/L) over preceding 14 days
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
Time frame: From baseline to week 16
Blood glucose percentage time above range (10.1-13.9mmol/L and >13.9 mmol/L) over preceding 14 days
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
Time frame: From baseline to week 16
Glycaemic variability index
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on Continuous Glucose Monitor (CGM) metrics
Time frame: From baseline to week 16
C-peptide level
To investigate if trial outcomes are associated with baseline c-peptide levels
Time frame: At baseline
Proportion of participants with non-acidotic ketosis
To investigate the effect of sotagliflozin 200mg once daily in addition to standard of care on ketone levels
Time frame: From baseline to week 16
Started Jan 2025 (actual). Primary completion is estimated for Oct 2027, 33 months after the start.
Of 83 non-industry phase 2 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 76. This study's planned 33 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Sotagliflozin