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Ongoing Clinical Trials for Type 2 Diabetes Mellitus

There are currently 43 clinical trials investigating new treatments and approaches for managing Type 2 Diabetes Mellitus. These studies are testing various medications, treatment combinations, and strategies to improve blood sugar control, reduce complications, and enhance quality of life for people living with this condition. Trials are being conducted across multiple countries in Europe and involve both new investigational drugs and established medications used in novel ways.

Clinical trial locations

Comparison of dapagliflozin and oral semaglutide effectiveness in type 2 diabetes patients based on insulin resistance or secretion deficit

This Italian trial aims to determine whether different characteristics of diabetes respond better to specific medications. The study compares two oral medications: dapagliflozin, which helps the kidneys remove excess sugar through urine, and semaglutide, which helps the body produce more insulin when blood sugar levels are high.

Main inclusion criteria: Adults aged 20-70 years with inadequate blood sugar control despite taking metformin for at least 6 months. Participants must have HbA1c levels between 7.5% and 9%, which indicates suboptimal diabetes control.

Main exclusion criteria: The study excludes individuals with type 1 diabetes, severe kidney or liver disease, history of pancreatitis, active cancer, recent heart attack, or severe allergic reactions to similar medications.

Study focus: Researchers will use various blood markers to identify whether patients have primarily insulin resistance or reduced insulin secretion. Based on these characteristics, the study will evaluate which medication works better for each type of patient, potentially leading to more personalized treatment approaches.

Investigational drugs: Dapagliflozin works by helping the kidneys remove excess sugar through urine. Oral semaglutide mimics a natural hormone that stimulates insulin production, reduces sugar production by the liver, and slows digestion.

Remote Study on Empagliflozin and Finerenone for Reducing Kidney Issues in Type 2 Diabetes Patients

This innovative Dutch study is conducted entirely remotely, allowing participants to take part from their homes using digital technologies. The trial investigates whether combining empagliflozin and finerenone can improve kidney health in people with diabetes who have albumin in their urine, a sign of kidney damage.

Main inclusion criteria: Adults with type 2 diabetes who have elevated urine albumin levels and kidney function above a certain threshold. Participants must be Dutch-speaking and able to use digital health technologies.

Main exclusion criteria: The study does not specify detailed exclusion criteria beyond the basic eligibility requirements related to diabetes status and albuminuria levels.

Study focus: The primary goal is to assess whether this medication combination can reduce the amount of protein in urine, which would indicate improved kidney protection. Researchers will also monitor blood pressure, body weight, and kidney function throughout the study.

Investigational drugs: Empagliflozin helps control blood sugar by causing the kidneys to remove glucose through urine. Finerenone protects the kidneys by reducing inflammation and scarring processes that damage kidney tissue.

Study of Orforglipron for Weight Management in People with Obesity or Overweight, With or Without Type 2 Diabetes

This trial, conducted in Czechia and Germany, evaluates a new medication called orforglipron for weight management in individuals who are overweight or obese, regardless of whether they have diabetes. The study runs for 40 weeks and aims to determine if orforglipron can help people achieve significant weight loss.

Main inclusion criteria: Adults with a BMI of 30 or higher, or a BMI of 25 or higher with at least one weight-related health condition such as high blood pressure, abnormal cholesterol levels, or cardiovascular disease. Participants with diabetes must have HbA1c levels between 7% and 10%.

Main exclusion criteria: Individuals outside the target BMI range, those unable to tolerate the study medications, pregnant or breastfeeding women, and people with certain heart, liver, or kidney problems.

Study focus: Researchers will measure changes in body weight and blood sugar control over the 40-week treatment period. The study also evaluates whether participants can achieve specific weight loss targets and improvements in other health markers.

Investigational drugs: Orforglipron is a GLP-1 receptor agonist taken as a once-daily tablet. It works by mimicking natural hormones that regulate blood sugar and appetite, potentially leading to weight loss and improved diabetes control.

Study on Dapansutrile for Patients with Type 2 Diabetes Not Well Controlled on Standard Treatment

This multi-country trial (France, Belgium, Germany) investigates whether dapansutrile, a medication that reduces inflammation, can improve blood sugar control in people whose diabetes is not adequately managed with current treatments. The study lasts 26 weeks and compares dapansutrile to placebo.

Main inclusion criteria: Adults aged 18-75 years diagnosed with type 2 diabetes for at least 6 months, with HbA1c levels between 7.7% and 11.0%. Participants must have elevated inflammation markers and be taking stable doses of metformin.

Main exclusion criteria: Individuals with type 1 diabetes, recent heart attack or stroke, severe kidney or liver disease, uncontrolled high blood pressure, history of diabetic ketoacidosis, or current use of insulin.

Study focus: The trial evaluates whether reducing inflammation through dapansutrile can improve blood sugar control when added to standard diabetes treatment. Researchers will monitor HbA1c changes and other indicators of diabetes management.

Investigational drugs: Dapansutrile works by inhibiting the NLRP3 inflammasome, a part of the inflammatory response that may affect insulin sensitivity. By reducing inflammation, it may help the body use insulin more effectively.

Study on Fecal Microbiota Transfer for Better Diabetes Control in Adults with Type 2 Diabetes After Bariatric Surgery

This French study explores an innovative approach to diabetes management by transferring healthy gut bacteria to patients who have not achieved diabetes remission after weight loss surgery. The treatment involves taking capsules containing beneficial bacteria from healthy donors.

Main inclusion criteria: Adults aged 18-65 years who had bariatric surgery 1-5 years ago but have not achieved diabetes remission. Participants must have HbA1c levels greater than 6.5% or be taking diabetes medications.

Main exclusion criteria: Individuals who are not in non-diabetic remission or who are part of vulnerable populations are excluded from the study.

Study focus: Researchers will monitor changes in blood sugar control and insulin function over 6 months, with long-term follow-up extending to 2 years. The study aims to understand whether restoring healthy gut bacteria can improve diabetes outcomes.

Investigational drugs: Fecal microbiota transfer involves capsules containing processed stool from healthy donors, which introduces beneficial bacteria into the patient’s digestive system. This approach may improve metabolism and insulin sensitivity.

Study on Heart Health in Type 2 Diabetes Patients Using Semaglutide and Dapagliflozin Combination

This Danish study uses heart CT scans to identify patients at risk of developing heart disease and determines whether early treatment can prevent cardiovascular complications. The trial combines multiple medications including semaglutide and dapagliflozin.

Main inclusion criteria: Men aged 55-69 years or women aged 60-74 years with type 2 diabetes according to WHO criteria. Participants must provide signed consent after understanding all study details.

Main exclusion criteria: Individuals with known cardiovascular disease cannot participate, as the study focuses on prevention in people without existing heart conditions.

Study focus: The trial evaluates whether using CT scan results to guide treatment decisions can reduce the risk of heart attacks, strokes, and heart-related deaths. Researchers will monitor participants until 2028.

Investigational drugs: The study uses a combination approach with semaglutide injections and dapagliflozin tablets, along with other heart medications as needed based on CT scan findings. This strategy aims to protect both the heart and blood vessels.

Study on Insulin Aspart for Recovery from Low Blood Sugar in People with and without Type 2 Diabetes

This Austrian study investigates how people with and without diabetes respond to low blood sugar levels and recover from them. The research uses controlled conditions to lower blood sugar and then monitors the body’s natural recovery mechanisms.

Main inclusion criteria: Adults aged 18-64 years, either with type 2 diabetes diagnosed for at least 6 months and managed with diet, exercise, and metformin, or healthy individuals without diabetes. All participants must have good venous access for blood sampling.

Main exclusion criteria: History of severe allergic reactions to study medications, current pregnancy or breastfeeding, drug or alcohol abuse, uncontrolled high blood pressure, severe kidney or liver disease, or recent heart attack or stroke.

Study focus: Researchers will measure how much insulin is needed to lower blood sugar to specific levels and how quickly participants recover from low blood sugar. This information helps understand differences between people with and without diabetes.

Investigational drugs: Insulin aspart is a fast-acting insulin used to create controlled low blood sugar conditions for research purposes. The study uses it to understand the body’s response to and recovery from hypoglycemia.

Study on Personalized Treatment Using Dapagliflozin, Dulaglutide, and Metformin for Patients with Uncontrolled Type 2 Diabetes

This Spanish trial tests whether using genetic information to guide medication choices can improve diabetes control compared to standard treatment approaches. The study includes multiple medication options and lasts 24 weeks.

Main inclusion criteria: Adults aged 40-70 years with BMI between 25 and 40, diagnosed with type 2 diabetes with HbA1c between 7% and 9.5%. Participants must be on stable diabetes treatment for at least 6 months without using insulin.

Main exclusion criteria: History of severe allergic reactions, current participation in other trials, drug or alcohol abuse, uncontrolled high blood pressure, severe kidney or liver disease, or recent major surgery.

Study focus: The trial compares outcomes between patients receiving treatment based on their genetic makeup versus those receiving optimized standard treatment. Researchers will evaluate blood sugar control, weight changes, and treatment satisfaction.

Investigational drugs: The study uses various medications including dapagliflozin, dulaglutide, and metformin, selected based on either genetic testing results or standard clinical guidelines.

Study on Testosterone Undecanoate Effects on Liver Fat in Obese Men with Low Testosterone and Type 2 Diabetes or Prediabetes

This Austrian study investigates whether testosterone replacement therapy can reduce liver fat in obese men with low testosterone levels and diabetes or prediabetes. The trial lasts 52 weeks initially, with an optional extension to 160 weeks.

Main inclusion criteria: Men with type 2 diabetes or prediabetes, HbA1c between 5.7% and 9.0%, BMI of 25 or higher, and confirmed low testosterone levels. Participants must be on stable doses of certain diabetes medications.

Main exclusion criteria: Women cannot participate, as the study focuses specifically on testosterone therapy in men. Other exclusions include individuals without the target conditions.

Study focus: Researchers will use magnetic resonance spectroscopy to measure changes in liver fat content. The study also evaluates effects on body fat distribution and cardiovascular health markers.

Investigational drugs: Testosterone undecanoate is given as an intramuscular injection. The study examines whether supplementing testosterone can improve metabolism and reduce liver fat accumulation in men with diabetes and low testosterone.

Study on the Effect of Raxtozinameran Vaccine in Reducing Type 1 Diabetes Risk in Children with High Genetic Susceptibility

This multi-country trial (Poland, Germany, Austria, Sweden, Belgium) investigates whether COVID-19 vaccination in early childhood can reduce the risk of developing type 1 diabetes in children with high genetic risk. The study monitors children until 2029.

Main inclusion criteria: Children aged 3-4 months with high genetic risk (more than 10%) of developing islet autoantibodies by age 6, based on specific genetic markers and family history of type 1 diabetes.

Main exclusion criteria: The study focuses on children with high genetic risk, so those without identified risk factors would not be eligible.

Study focus: Researchers will monitor whether early COVID-19 vaccination affects the development of markers that predict type 1 diabetes. The study examines whether preventing certain infections might reduce autoimmune responses leading to diabetes.

Investigational drugs: The Comirnaty Omicron XBB.1.5 COVID-19 mRNA vaccine is used. While primarily a vaccine study, researchers are exploring its potential protective effects against type 1 diabetes development.

Summary

The 43 ongoing clinical trials for Type 2 Diabetes Mellitus represent a diverse landscape of research spanning multiple European countries. Several notable patterns emerge from this collection of studies.

Geographic distribution shows strong concentration in Central and Eastern Europe, with countries like Germany, Poland, Spain, and Romania hosting numerous trials. Multi-country collaborations are common, particularly for large cardiovascular outcome studies, reflecting the need for substantial participant numbers to detect meaningful differences in heart-related events.

Treatment approaches fall into several categories. Many trials focus on newer medication classes, particularly GLP-1 receptor agonists like semaglutide and tirzepatide, and SGLT-2 inhibitors such as dapagliflozin and empagliflozin. These medications are being studied both individually and in various combinations. A significant trend involves personalized medicine approaches, with several studies using genetic information or biomarkers to guide treatment selection.

Innovative strategies include remote digital trials, fecal microbiota transfer for gut health modulation, and preventive approaches using heart imaging to identify at-risk patients before complications develop. Some studies specifically address underserved populations, including children and adolescents with type 2 diabetes and elderly patients.

Beyond blood sugar control, many trials evaluate broader health outcomes including cardiovascular protection, kidney function preservation, weight management, bone health, and diabetic eye disease. This reflects growing recognition that diabetes care must address multiple aspects of patient health rather than focusing solely on glucose levels.

The research portfolio includes both established medications tested in new contexts and entirely novel compounds in early development stages. This balanced approach ensures both near-term improvements in existing treatment strategies and potential breakthrough therapies for the future.

Ongoing Clinical Trials on Type 2 diabetes mellitus

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

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    Bulgaria Croatia Germany Hungary Poland Portugal +1

  • A Study of Zenagamtide in Adults With Overweight or Obesity and Type 2 Diabetes

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    Croatia Hungary Italy Romania Slovakia

  • Study of vicadrostat and empagliflozin combination in patients with type 2 diabetes, high blood pressure and cardiovascular disease

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    Austria Belgium Bulgaria Croatia Czechia Denmark +17

  • A study to evaluate the effect of CX11 trometamol monohydrate in patients with type 2 diabetes

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    Poland

  • A study to evaluate the effectiveness of NNC0662-0419 and semaglutide in people with type 2 diabetes

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    Croatia Hungary Poland Portugal Slovakia Spain

  • A study to evaluate the effects of obicetrapib and ezetimibe on cholesterol levels in adults with type 2 diabetes or metabolic syndrome

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    Czechia The Netherlands Slovakia

  • Study comparing cagrilintide and semaglutide versus tirzepatide in people with type 2 diabetes taking metformin or SGLT2 inhibitor

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    Germany Greece Hungary Poland Romania Spain

  • Study of LY3457263 compared to placebo in adults with type 2 diabetes who are taking semaglutide or tirzepatide but have not reached their blood sugar goals

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    Germany Poland

  • Study on the Effects of Ertugliflozin and Semaglutide on Heart Health in Patients with Type 2 Diabetes

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    Italy

  • Study on the Effect of Semaglutide on Healing Foot Ulcers in Patients with Type 2 Diabetes

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    Denmark

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