Clinical Research Directory

A Study of BGM0504 in Early T2DM With Obesity

This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.

A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

This trial is conducted in Indonesia. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin in patients with type 2 diabetes

Pancreatin Added to Standard Antihyperglycemic Therapy in Patients With Type 2 Diabetes

Medications that enhance the incretin effect (GLP-1 receptor agonists, tirzepatide (GIP/GLP-1 receptor agonist) and DPP-4 inhibitors) are used in treatment of patients with type 2 diabetes. GLP-1 agonists and tirzepatide not only effectively lower blood glucose levels but also promote weight loss-primarily by stimulating the satiety center in the central nervous system - and reduce cardiovascular risk. Evidence suggests that oral pancreatin supplementation also enhances the incretin effect by increasing GIP and GLP-1 concentrations, and consequently insulin levels, which translates into a reduction in postprandial glycemia in patients with cystic fibrosis or chronic pancreatitis. In our study we aim to evaluate the impact of pancreatin on the incretin effect and glycemic control in patients with type 2 diabetes without exocrine pancreatic insufficiency.

DIabetes GLycemic Assessment in Newly Confirmed Episodes

This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose \[SMBG\] using conventional glucometers). The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.

PLEASURE (Pleasing Lovers, Efficacy, Arousal, Satisfaction, and Uptake Research on Eroxon)

The purpose of this research study is to look at whether Eroxon® gel when used together with tadalafil, may help improve erectile function in men ages 18 to 40 who have type 2 diabetes.

A Multicenter Randomized Double-Blind Trial of Chrocare CDSS for Integrated Management of Type 2 Diabetes

This is a multicenter, randomized, double-blind, parallel-group clinical study for adults with type 2 diabetes and early diabetic kidney or retinal complications. A total of 1,200 eligible participants will be randomly divided into two groups at a 1:1 ratio. Participants in the intervention group will receive clinical management suggestions generated by the Chrocare large language model clinical decision support system, while those in the control group will receive standard diabetes care formulated by experienced endocrinologists. All participants will complete 3 study visits over 6 months to test blood glucose, glycated hemoglobin, blood lipids, kidney and eye indicators, and record hypoglycemia or other adverse events. The main goal of this research is to compare whether the AI-assisted management can help more patients reach target blood glucose levels, as well as evaluate the safety of this AI system for long-term diabetes integrated treatment.

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome

This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.

Clinical Evaluation of Salivary 1,5-Anhydroglucitol in Diabetes

The goal of this observational study is to evaluate the clinical value of salivary 1,5-anhydroglucitol (1,5-AG) and assess a novel noninvasive detection approach in individuals with and without type 2 diabetes. Additionally, the study will examine the relationships of salivary 1,5-AG with serum 1,5-AG and continuous glucose monitoring (CGM) measures of short-term glycemic control and fluctuations.

Vitamin D and Type 2 Diabetes - Treat-To-Target

This study tests whether taking a weekly dose of vitamin D, with the dose adjusted to reach a target blood vitamin D level, can help control blood sugar levels in adults at high risk of developing type 2 diabetes (prediabetes). Research suggests that vitamin D may play a role in blood sugar control. The goal of this study is to see whether adjusting the dose of vitamin D to reach a specific blood vitamin D level improves blood sugar control compared with a placebo (a look-alike pill without vitamin D). One hundred adults aged 30 to 74 with prediabetes will take part. Participants will be randomly assigned (by chance) to receive either weekly vitamin D supplements or a placebo. Neither the participants nor the research team will know which group a participant is in during the study. Participants in the vitamin D group will start with one specific dose. After three months, a blood test will be used to decide whether the dose should stay the same or be increased to reach the target vitamin D level. Participants in the placebo group will continue taking the placebo each week. All participants will be followed for about 18 months. During the study, they will attend scheduled study visits, have blood tests, and wear a continuous glucose monitor, a small device that measures blood sugar levels throughout the day and night. The research team will also make periodic phone calls to check on health changes, medication use, and study participation. The main outcome of the study is the proportion of time that the participants' blood sugar levels remains in a healthy range.

CGM-Based Glycemic Analysis After ESI

The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes. The main questions it aims to answer are: Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups? Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device. Participants will: * Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection

Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

The goal of this pilot clinical trial is to examine how receipt of ingredients for a Mediterranean diet (with or without nutrition classes) impacts Type 2 Diabetes Mellitus risk factors among adults in the US South. The main question it aims to answer is: \- Will greater improvements in diet quality (HEI Score) and body weight be seen in the group that receives grocery delivery and nutrition classes (TK+FiM) compared to the group receiving grocery delivery only (FiM only)? Researchers will evaluate the changes in diet quality and body weight among participants in each group to see which group experiences greater improvements. Participants will: * be randomly assigned to either receive weekly grocery deliveries and attend weekly virtual nutrition classes for 4 weeks or receive weekly grocery deliveries only. * be asked to complete surveys/questionnaires at the baseline and 4-week timepoints in the study. * be asked to participate in a post-study focus group to talk about their experiences during the intervention.

The GRoceries Aimed at Increasing Nutrition Study

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data

The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants. Indications Studied: Apparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs). Study Design: Single-country, multicenter, prospective, longitudinal survey. Objectives: The study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting. The study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.

Salivary Cortisol and Hypercortisolism in Type 2 Diabetes

The goal of this observational study is to explore the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes despite receiving standard-of-care therapies. Additionally, the study will evaluate the correlation between salivary cortisol levels and glycemic control.

CGM-Assisted Community Management for Type 2 Diabetes

This non-randomised, parallel-group pragmatic study used a type 2 effectiveness-implementation hybrid design to evaluate a continuous glucose monitoring (CGM)-assisted community management strategy for adults with type 2 diabetes in Yinzhou District, Ningbo, China. The study was conducted at two community health institutions that routinely provided chronic disease management services. Group assignment was not randomised and involved participant self-selection. A total of 599 participants were enrolled, including 292 participants in the CGM-assisted management group and 307 participants in the usual-care group. The intervention was a multicomponent CGM-assisted management strategy rather than the use of a CGM device alone. It included a CGM device with a mobile application and clinician-facing data platform, structured training for community providers, one-to-one patient education, a standardised workflow for interpreting glucose patterns and providing dietary, physical-activity, and medication-management advice, and three scheduled 14-day CGM wear periods at weeks 0, 8, and 16. After each wear period, participants returned for clinician review and management adjustment. Participants in the usual-care group continued routine community diabetes management, including self-monitoring of blood glucose. The primary effectiveness outcome was the between-group difference in HbA1c at 24 weeks. Secondary effectiveness outcomes included clinically meaningful HbA1c reductions and target attainment, fasting plasma glucose, body-mass index, lipid measures, behavioural changes, and changes in glucose-lowering medication management. CGM-derived glycaemic metrics were assessed descriptively within the intervention group across the three wear periods. Implementation outcomes were evaluated using the RE-AIM framework and included study-period reach, institutional and provider adoption, intervention delivery fidelity, participant completion, provider-perspective delivery cost, willingness to continue CGM use, participant satisfaction, and continuation of CGM-related services at the participating sites. The study aimed to assess both the effectiveness of CGM-assisted management and its implementation within routine Chinese community diabetes care.

Cardiovascular Risk in T2DM With MAFLD: A Cohort Study

This study aims to address the following key scientific question by establishing a large-scale, high-standard clinical cohort: the independent contribution of MASLD and its progression to liver fibrosis on cardiovascular outcomes in patients with T2DM, after excluding the confounding effects of traditional cardiovascular risk factors. Its technical value lies in utilizing prospective follow-up data combined with a multivariable competing risks model to develop and validate a cardiovascular risk prediction and early warning system tailored for Chinese populations with T2DM complicated by MASLD. Clinically, the findings will provide interdisciplinary evidence-based support for endocrinology and cardiology, helping clinicians identify high-risk individuals and prevent cardiovascular events through early intervention targeting hepatic metabolic disorders. This has significant implications for reducing overall mortality among diabetic patients in China and alleviating the public health burden.

Effect of Ajwa Seed Powder on HbA1c and Body Composition in Overweight and Obese Patients With Type 2 Diabetes Mellitus

The goal of this interventional study (clinical trial) is to check if ajwa seed powder can treat type 2 diabetes mellitus in overweight and and obese patients with type 2 diabetes mellitus including both male and female of the age group between 30-50. The main question is what would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus which aim to result in better glycemic control particular Hba1c, and body composition improvement in type 2 diabetes mellitus patients Participants will be asked to consume 4 grams of ajwa seed powder per day

TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy

This Phase 2a, randomized, double-blind, active-controlled study will evaluate the safety, tolerability, and preliminary efficacy of TriGlytza®-01 compared with metformin in adults with Type 2 diabetes inadequately controlled despite metformin therapy. Participants will be randomized to one of three treatment groups and treated for 16 weeks. Safety, glycaemic control, body weight, and other metabolic outcomes will be assessed

HCC Risk and Monitoring in Patients With Type 2 Diabetes

Liver cancer is a significant malignancy in Taiwan. With the widespread implementation of antiviral therapies, hepatitis B and C-related liver cancer has gradually declined; however, metabolic dysfunction-associated liver cancer continues to increase, particularly among patients with type 2 diabetes mellitus (T2DM) who also present with significant liver fibrosis. Current clinical guidelines lack standardized recommendations for liver cancer screening in this specific population, and data from prospective randomized controlled trials remain scarce.This study is a prospective randomized controlled trial enrolling patients aged 18 years, diagnosed with T2DM, and with a FIB-4 \> 2.67. Participants will be randomly assigned to either the surveillance group or the standard-care group. The surveillance group will undergo blood tests every 6 months to monitor liver function, AFP, and PIVKA-II, alongside the calculation of the GAAD score. The standard-care group will receive liver function tests every 6 months according to routine clinical practice. Abdominal ultrasound or computed tomography (CT) scans will be arranged by clinicians when clinically indicated. All participants will undergo abdominal ultrasound at baseline and at the end of the third year, with blood samples and clinical data collected periodically. The primary endpoint of this study is the tumor size at the time of liver cancer diagnosis. Secondary endpoints include liver cancer staging, number of liver cancer tumors, liver cancer incidence, the proportion of patients receiving curative treatment, and the degree of liver fibrosis as reflected by changes in FIB-4. This study expects to clarify the clinical benefits of a GAAD score-based surveillance strategy compared to standard care in T2DM patients with high FIB-4 scores, thereby providing evidence-based support for future liver cancer screening strategies and clinical guidelines.

Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes

Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.

Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine

The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels. This may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values. The study aims to answer two main questions: 1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold? 2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol/mol)?

Remission Evaluation of Metabolic Interventions in Type 2 Diabetes in Primary Care (REMIT-Prime)

The Remission Evaluation of Metabolic Interventions in Type 2 diabetes (REMIT) program incorporates a non-surgical-remission-inducing therapeutic approach, pairing health coaching with physician-led pharmacotherapy. This approach has been tested in 5 multi-cite trials (1 pilot, 3 completed and 1 ongoing) and suggests an intensive short-term intervention with passive follow up supports patients in achieving remission. Further research is needed to evaluate the feasibility of the short-term REMIT intervention in real-world settings such as primary care and inform the future rollout of the program in multiple sites across Ontario. The REMIT-Prime study will evaluate the REMIT short-term metabolic intervention in a primary care setting (Hamilton, Ontario), with the aims of investigating the feasibility and acceptability of the REMIT intervention in primary care settings and understanding the context for implementation. One hundred and eighteen eligible participants from the primary care site will be offered the REMIT intervention or waitlisted as a natural control group. The study protocols will be collaboratively designed and finalized with a primary care team and patient partners to elicit feedback on the adoption and feasibility of the intervention in primary care. Healthcare professionals from the CFFM will also be interviewed and asked to describe their experiences with the intervention. The findings from these interviews will support the rapid translation and rollout of the REMIT program in other interested primary care sites, including in London and Cambridge, Ontario.

Influence of Gut Microbiota on the Development of Type 2 Diabetes Mellitus and Personalization of Diabetes-lowing Therapy

An observational, single-center, prospective study was conducted to examine the impact of CM on the development of T2DM and the personalization of initial SST in patients with newly diagnosed T2DM who had not previously received SST. These patients were hospitalized at the V.P. Demikhov City Clinical Hospital between October 2021 and February 2022 due to hyperglycemia detected incidentally at their place of residence. The sample consisted of men and women aged 18 to 80 years. After hospitalization, the diagnosis of newly diagnosed T2DM was confirmed twice using any available laboratory diagnostic methods: fasting venous blood glucose greater than 7.0 mmol/L or greater than 11.1 mmol/L when randomly determined; glucose greater than 11.1 mmol/L 2 hours after oral administration of 75 g of glucose; and HbA1c greater than 6.5%. After double confirmation of the T2DM diagnosis, 100 patients with newly diagnosed T2DM who had not previously received SST and met the inclusion criteria were included in the study. At the first visit, after assessing patient compliance with the inclusion and exclusion criteria, anamnesis was collected, anthropometric analysis was performed, and intravenous blood was drawn for hormonal (insulin, C-peptide, glucagon, GLP-1) and biochemical blood tests (glucose, HbA1c, TC, LDL, HDL, TG, creatinine, urea, ALT, AST, total bilirubin). Glucagon and GLP-1 levels in the blood were measured on an empty stomach (0 min. point) and 30 minutes after a standard breakfast (30 min. point). Also, at the first visit, in order to assess the composition of the CM, 100 patients underwent stool sampling for 16S rRNA sequencing. At the 2nd visit, as laboratory test results became available, patients were randomized to monotherapy or combination therapy groups depending on the HbA1c level in accordance with the 2019 Algorithms for Specialized Care for Patients with Diabetes Mellitus \[164\]. Metformin was prescribed as monotherapy at a daily dose of 2000 mg (n = 20), and innovative CAPs were added to metformin as combination therapy: DPP-4 inhibitors (n = 20) / GLP-1 arginine (n = 20) / NGLT-2 inhibitors (n = 20) or DPP-4 inhibitors + insulin glargine 300 U/ml (n = 20)/ The effectiveness of the treatment was assessed at the third visit based on HbA1c levels after three months of treatment. If target glycemic levels were not achieved after three months of treatment, the HbA1c levels were adjusted at the third visit based on national recommendations.

The Effect of OptiFibre Dietary Fiber on Carbohydrate Metabolism and Intestinal Microbiota Metabolism in Patients With Type 2 Diabetes Mellitus

The goal of this clinical trial is to to study the effect of Optifiber PHGG on carbohydrate metabolism in patients with type 2 diabetes mellitus. The main questions it aims to answer are: 1. To study in detail the effect of Optifiber HCTK on carbohydrate metabolism in patients with type 2 diabetes mellitus. 2. To study the effect of Optifiber HCTK on the lipid profile of patients with type 2 diabetes mellitus. 3. To study the effect of Optifiber HCTK on the metabolites of the intestinal microbiota in patients with type 2 diabetes mellitus. 4. To study the effect of Optifiber HCTK on weight loss and waist circumference reduction in patients with type 2 diabetes mellitus. The observational study is planned to include approximately 80 patients diagnosed with type 2 diabetes mellitus, with 40 patients divided into the main and control groups. In the control group, the necessary information will be collected retrospectively using archived patient data. In the main (study) group, data will be collected prospectively.