Ongoing Clinical Trials for Glucose Tolerance Impairment
This article presents 7 ongoing clinical trials investigating treatments for impaired glucose tolerance. These trials are exploring various medications including semaglutide, metformin, dapagliflozin, pioglitazone, pramlintide, testosterone, and novel therapies across Belgium, Austria, Poland, Germany, Spain, and Denmark. (Also known as: Prediabetes, Glucose intolerance, Impaired fasting glucose)
Clinical trial locations
- Austria
- Belgium
- Denmark
- Germany
- Poland
- Spain
Study of Semaglutide for Treating Prediabetes in Women with Previous Gestational Diabetes
This trial is designed specifically for women who experienced gestational diabetes during pregnancy and now have glucose intolerance. The study aims to prevent or delay the development of type 2 diabetes using semaglutide, a medication administered once weekly by injection under the skin.
Who can participate: Female participants must be between 6 and 24 weeks after childbirth, have a confirmed history of gestational diabetes diagnosed between 24-32 weeks of pregnancy, and show glucose intolerance after stopping breastfeeding. Participants must be able to communicate in Dutch, French, or English and use highly effective birth control methods such as implants, injections, birth control pills, certain IUDs, or have a partner who has had a vasectomy.
Who cannot participate: Male individuals cannot join this study. Women who do not have prediabetes or who belong to vulnerable populations requiring special protection are also excluded.
What the study involves: The trial compares semaglutide (1 mg weekly) with a placebo over 160 weeks (approximately 3 years). Researchers will monitor blood sugar levels through fasting tests, oral glucose tolerance tests, and HbA1c measurements. The study tracks whether semaglutide can effectively prevent progression to type 2 diabetes, along with secondary outcomes including body weight changes and the need for additional diabetes treatment.
Investigational drug: Semaglutide helps the body produce more insulin when blood sugar levels are high and reduces the amount of sugar released by the liver, helping to maintain more stable blood sugar levels over time.
Study on Testosterone Undecanoate Effects on Liver Fat in Obese Men with Low Testosterone and Type 2 Diabetes or Prediabetes
This Austrian trial investigates whether testosterone replacement therapy can reduce liver fat in obese men who have both low testosterone levels and either type 2 diabetes or glucose intolerance. The study focuses on understanding how testosterone affects body fat distribution and heart-related health factors.
Who can participate: Men aged 18-75 years with a BMI of 25 kg/m² or higher must have confirmed low testosterone levels through two separate blood tests. Participants need HbA1c levels between 5.7% and 9.0%, fasting glucose of 100 mg/dl or higher, or postprandial glucose of 140 mg/dl or higher. They must be on stable doses of medications like Metformin for at least 8 weeks, SGLT2 inhibitors for at least 3 months, or long-acting insulin for at least 8 weeks, and must be willing to maintain the same diet and physical activity levels during the study.
Who cannot participate: Women cannot participate in this study. Men who do not have low testosterone levels, do not have type 2 diabetes or prediabetes, are not overweight or obese, or belong to vulnerable populations are excluded.
What the study involves: Participants receive testosterone undecanoate injections (1000 mg in 4 ml solution) or placebo for 52 weeks, followed by an additional 108-week phase where all participants receive the testosterone treatment. Liver fat content is monitored using magnetic resonance spectroscopy, and various health assessments are conducted throughout the study period, which concludes by December 2026.
Investigational drug: Testosterone undecanoate is administered as an intramuscular injection and works by supplementing testosterone levels, which can influence fat distribution and improve metabolic parameters in men with low testosterone and glucose intolerance.
Study on the Effects of Semaglutide, Dapagliflozin, and Metformin in Patients with Coronary Artery Disease and Prediabetes
This Polish study examines how three different diabetes medications affect the buildup of plaque in heart arteries in people who have both coronary artery disease and glucose intolerance. The trial compares oral medications taken as tablets to determine which is most effective in slowing or reversing arterial plaque.
Who can participate: Adults aged 18-80 years with coronary artery disease showing at least 20% narrowing in heart blood vessels must have glucose intolerance confirmed by specific blood tests. Participants need a good-quality heart CT scan performed within 3 months before joining and must have been managing heart health risks in a stable way for at least 4 weeks.
Who cannot participate: People with severe allergic reactions to study medications, uncontrolled high blood pressure, severe liver or kidney disease, pregnant or breastfeeding women, those who participated in another clinical trial within 30 days, or individuals with a history of drug or alcohol abuse within the past year cannot join.
What the study involves: The 24-month study randomly assigns participants to receive either Rybelsus (semaglutide 3 mg, 7 mg, or 14 mg), Forxiga (dapagliflozin 10 mg), Formetic (metformin 500 mg), or placebo, all taken orally alongside diet and lifestyle modifications. Coronary plaque volume changes are measured using CT scans, along with monitoring weight, blood pressure, and cholesterol levels.
Investigational drugs: Semaglutide mimics a natural hormone that helps regulate blood sugar and may benefit heart health. Dapagliflozin is an SGLT-2 inhibitor that lowers blood sugar by causing kidneys to remove sugar through urine. Metformin helps manage blood sugar levels and serves as a comparison medication in this trial.
Study on the Safety and Effectiveness of Tregs and Rituximab for Children with Early Stage Type 1 Diabetes
This trial focuses on children who show early signs of developing type 1 diabetes but have not yet experienced symptoms. The study tests whether a combination of regulatory T cells and Rituximab can delay or prevent the full development of type 1 diabetes.
Who can participate: Children aged 6-16 years weighing at least 20 kg with a BMI between the 25th and 75th percentile must have positive autoantibody levels and normal blood sugar levels. They should have fasting blood sugar less than 100 mg/dl, normal glucose tolerance test results, C-peptide levels of at least 1.0 ng/ml, and HbA1c less than 5.7%. Legal guardians must be capable of managing diabetes care, including checking blood sugar at least three times daily.
Who cannot participate: Children outside the specified age range, those already diagnosed with stage 2 or 3 type 1 diabetes showing abnormal blood sugar levels or symptoms, those with serious health conditions interfering with the study, those taking medications affecting study results, those with recent infections, history of allergic reactions to study medications, or unable to follow study procedures are excluded.
What the study involves: The four-week study administers treatments through intravenous infusion, comparing the combination of Tregs and Rituximab against each treatment alone and placebo. Researchers monitor how long it takes for symptoms of type 1 diabetes to develop and track participants’ health over an extended period.
Investigational drugs: Rituximab targets specific immune cells involved in the immune response. Regulatory T cells are specially prepared immune cells that help control the immune system and prevent it from attacking the body’s insulin-producing cells in the pancreas.
Evaluation of controlled-ileal-release nicotinic acid tablets compared to placebo for treating people with prediabetes
This German study tests a special form of nicotinic acid (vitamin B3) designed to release in a controlled manner in the small intestine. The trial aims to determine if this medication can help people with glucose intolerance achieve normal blood sugar levels.
Who can participate: Adults aged 18-79 years with a BMI of 20 kg/m² or higher must have been diagnosed with glucose intolerance according to current European medical guidelines. Participants cannot belong to vulnerable population groups such as prisoners or mentally disabled persons unable to give informed consent.
Who cannot participate: People younger than 18 or older than 65 years, those with diagnosed type 1 or type 2 diabetes, pregnant or breastfeeding women, those taking medications affecting blood sugar, individuals with serious heart conditions, severe kidney or liver disease, active cancer, uncontrolled high blood pressure above 140/90 mmHg, BMI below 18.5 or above 40, history of bariatric surgery, substance abuse in the past 12 months, major psychiatric disorders, or allergies to study medication components cannot participate.
What the study involves: The 26-week study compares CIR-NA tablets (maximum daily dose 200 mg) taken orally with placebo. Researchers regularly monitor blood sugar levels through fasting tests, HbA1c measurements, and oral glucose tolerance tests to evaluate whether the medication improves glucose intolerance and prevents progression to type 2 diabetes.
Investigational drug: Controlled-ileal-release nicotinic acid is designed to minimize side effects while maintaining therapeutic benefits. This form of vitamin B3 may help regulate blood sugar levels and improve insulin sensitivity in people with glucose intolerance.
Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes
This Spanish trial investigates the best treatment approach for reducing liver fat in people who have both fatty liver disease and glucose intolerance. The study compares different combinations of two oral medications over 18 months.
Who can participate: Adults aged 18-75 years must have Metabolic Associated Fatty Liver Disease confirmed by MRI showing more than 10% liver fat content, a BMI between 25 and 40, and glucose intolerance shown by fasting blood sugar between 100-125 mg/dl, HbA1c between 5.7% and 6.4%, or blood sugar between 140-199 mg/dl two hours after a glucose tolerance test. Male participants or postmenopausal females can join.
Who cannot participate: People younger than 18 or older than 64 years, those with type 2 diabetes, history of excessive alcohol consumption (over 30g/day for men or 20g/day for women), other liver diseases such as viral hepatitis, medications known to cause fatty liver, pregnancy or planning pregnancy, active cancer or cancer treatment in past 5 years, serious heart conditions, inability to undergo MRI scanning, participation in other trials within 30 days, severe psychiatric disorders, chronic kidney disease, BMI greater than 40 kg/m², or regular use of anti-inflammatory medications are excluded.
What the study involves: Participants receive different combinations of pioglitazone (15 mg tablets) and metformin hydrochloride (500 mg tablets) taken orally alongside lifestyle recommendations. Liver fat content is measured using MRI scans, with regular blood tests, body composition measurements, and monitoring of intestinal bacteria throughout the 18-month treatment period, concluding in February 2026.
Investigational drugs: The trial information does not provide specific details about the mechanisms of action for pioglitazone and metformin in this study, though both are established medications for managing blood sugar levels.
Study of semaglutide and pramlintide combination therapy for people with obesity and prediabetes
This Danish trial examines how two medications work together to affect metabolism, body composition, and appetite in people with both obesity and glucose intolerance. The study investigates whether combining these treatments provides better results than using one medication alone.
Who can participate: Adults over 18 years with a BMI of 30 or higher and glucose intolerance confirmed by HbA1c levels between 39-47 mmol/mol can participate. Female participants must have a negative pregnancy test and agree to use contraception during the study.
Who cannot participate: People with BMI less than 30 kg/m², blood sugar levels outside the specified range, those younger than 18 or older than 65 years, pregnant or breastfeeding women, those with severe allergic reactions to similar medications, current participants in other trials, significant medical conditions interfering with results, use of weight loss medications in past 3 months, history of bariatric surgery, uncontrolled high blood pressure, eating disorders, serious psychiatric conditions, current substance abuse or alcohol dependency, or inability to follow study procedures are excluded.
What the study involves: The 26-week study begins with semaglutide injections under the skin for 25 weeks, followed by one week of combined semaglutide and pramlintide treatment. Participants undergo meal tests to measure food consumption and appetite at the beginning, after 25 weeks, and at week 26. Stomach emptying rates are assessed using a paracetamol test, and researchers track weight loss, body composition changes, and feelings of hunger and fullness throughout the study.
Investigational drugs: Semaglutide helps reduce appetite and food intake by mimicking a natural hormone, helping people feel full for longer periods. Pramlintide is a synthetic hormone that helps control blood sugar and reduces appetite by slowing stomach emptying, which helps people feel full longer and may reduce food intake.
Summary
These 7 clinical trials represent diverse approaches to managing impaired glucose tolerance across multiple European countries. Several notable patterns emerge from this collection of studies. Semaglutide appears in three separate trials, highlighting significant research interest in this medication’s potential for preventing diabetes progression in different populations, including women with previous gestational diabetes, people with coronary artery disease, and those with obesity.
The trials span a wide range of participant populations, from children as young as 6 years in the early-stage type 1 diabetes study to adults up to 80 years in the coronary artery disease trial. Geographic distribution shows research activity across Central and Western Europe, with Poland hosting two trials and individual studies in Belgium, Austria, Germany, Spain, and Denmark.
Treatment approaches vary considerably, from established oral medications like metformin and dapagliflozin to innovative therapies such as regulatory T cell infusions combined with Rituximab. Several trials focus on specific populations with additional health conditions, including coronary artery disease, fatty liver disease, obesity, and low testosterone levels in men. Study durations range from 4 weeks to 160 weeks, reflecting different research objectives from short-term safety assessments to long-term prevention studies.
Most trials employ placebo-controlled designs to rigorously evaluate treatment effectiveness, and several investigate combination therapies to determine optimal treatment strategies. These studies collectively aim to prevent or delay progression to type 2 diabetes while addressing related metabolic complications, representing important steps toward improving health outcomes for people with impaired glucose tolerance.
