Phase 3 Type 2 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 19 and older who have been diagnosed with both type 2 diabetes and high blood pressure (essential hypertension)
• People whose blood sugar control marker (HbA1c) is between 6.5% and 9.5%, and whose fasting blood sugar is no higher than 270 mg/dL, at the screening visit and again at the baseline visit
• People whose sitting systolic blood pressure (the top number) in the higher-reading arm is between 140 and 160 mmHg — or between 130 and 160 mmHg if currently taking blood pressure medication — at the screening visit, and between 140 and 160 mmHg at the baseline visit
• People who have either not used diabetes tablets in the 8 weeks before screening, or who have been taking metformin alone or metformin combined with one other diabetes tablet for at least 8 weeks before screening
• People whose doctor considers it appropriate for them to stop their current diabetes tablets (other than metformin) and blood pressure medications during the study, while continuing metformin at a minimum dose of 1,000 mg per day
• People who have not taken any diabetes tablets other than metformin (at the same dose of more than 1,000 mg per day) for at least 8 weeks before the baseline visit
• People who have not taken any blood pressure medications for at least 2 weeks before the baseline visit
• People who took at least 70% of the study medication as directed during the lead-in period before the baseline visit
• People who have read and understood the study information and have voluntarily signed a consent form
• For the optional extension phase: people who have completed all procedures in the main treatment period and have separately consented to the extension phase

Who may not be able to join:

• People whose diastolic blood pressure (the bottom number) in the reference arm is 110 mmHg or higher at screening or at the baseline visit
• People whose systolic blood pressure differs by 20 mmHg or more between arms, or whose diastolic blood pressure differs by 10 mmHg or more between arms, when measured at screening
• People with a BMI (body mass index) greater than 35 kg/m²
• People with any level of liver disease or impairment
• People with a blocked bile duct or problems with bile flow
• People whose liver enzyme levels (AST or ALT) are more than twice the upper limit of normal on blood tests
• People whose total bilirubin level is more than twice the upper limit of normal on blood tests
• People with moderate-to-severe kidney disease (confirm with trial site for exact kidney function threshold)
• People with conditions that may suddenly reduce kidney function, such as severe dehydration, serious infection, or circulatory collapse (shock)
• People currently experiencing a diabetic emergency such as pre-coma or coma
• People with a severe active infection or serious physical injury
• People with malnutrition, starvation, significant physical weakness, or problems with the pituitary or adrenal glands
• People with conditions that reduce oxygen in body tissues, such as respiratory failure, shock, or severe gastrointestinal problems including dehydration, persistent diarrhoea, or vomiting
• People who experience dizziness or faintness when standing up due to a drop in blood pressure (symptomatic orthostatic hypotension)
• People with clinically significant heart rhythm problems, such as ventricular tachycardia, atrial fibrillation, or atrial flutter
• People with certain serious structural heart conditions, including hypertrophic obstructive cardiomyopathy, severe coronary artery disease, or significant valve narrowing
• People with wasting diseases, autoimmune diseases, or connective tissue diseases
• People with uncontrolled urinary problems such as inability to urinate or severely reduced urine output
• People with gastrointestinal conditions that could affect how the study medication is absorbed, such as stomach ulcers, gastritis, Crohn's disease, or gastroesophageal reflux disease
• People who test positive for hepatitis B surface antigen (unless stably taking antiviral medication), or positive for hepatitis C antibodies (unless hepatitis C RNA test is negative)
• People who test positive for HIV
• People with a personal history of hereditary angioedema, or swelling reactions caused by ACE inhibitor or angiotensin II blocker medications
• People with certain inherited conditions affecting how the body processes sugars, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• People with type 1 diabetes, secondary diabetes, or a history of lactic acidosis, metabolic acidosis, or diabetic ketoacidosis
• People with a history of drug or alcohol misuse
• People with a history of secondary hypertension (high blood pressure caused by another medical condition), or a history that raises suspicion of this (confirm with trial site for full list of conditions)
• People who experienced severe heart failure (NYHA class III or IV), unstable angina, heart attack, or peripheral vascular disease within 24 weeks before screening
• People who experienced a serious stroke or brain bleeding event within 24 weeks before screening
• People who experienced moderate or severe eye disease related to diabetes (such as retinal bleeding or visual disturbance) within 24 weeks before screening
• People who had a urinary tract or genital infection within 16 weeks before screening
• People who have had a malignant cancer diagnosed within the past 5 years (some exceptions may apply depending on cancer type and time since being declared cancer-free — confirm with trial site)
• People who had weight-loss (bariatric) surgery or lap-band surgery within 12 months before screening
• People who had a heart procedure (coronary angioplasty or bypass surgery) within 24 weeks before screening
• People who took weight-loss medications within 12 weeks before screening
• People who took systemic corticosteroid (steroid) tablets or injections for 2 weeks or more within 8 weeks before screening (inhaled, topical, or locally applied steroids are generally permitted)
• People who received insulin injections or GLP-1 receptor agonist medications for more than 7 days (in total) within 8 weeks before screening
• People currently taking three blood pressure medications at the same time, or two blood pressure medications where one includes high-dose amlodipine (10 mg)
• People currently taking a diabetes tablet other than metformin as a single medication, or currently taking three diabetes medications including metformin
• People currently taking a medication containing aliskiren (a blood pressure drug)
• People currently receiving dialysis
• People who have a procedure planned that involves injecting iodine-based contrast dye into a vein (such as certain CT scans or angiograms) at any point from 48 hours before the lead-in period through to the end of the study
• People with a known allergy or sensitivity to dapagliflozin, telmisartan, or any other ingredients in the study medication
• People with a history of allergy or sensitivity to metformin or related medications (biguanides)
• People who took part in another clinical trial and received a trial treatment within 12 weeks before starting this study
• Women who are pregnant or breastfeeding
• Women and men who are able to have children and are planning a pregnancy, or who are unwilling to use an approved method of contraception from screening until 4 weeks after the last study dose (acceptable methods include hormonal contraception, IUD or IUS, surgical sterilisation, certain combinations of barrier methods with spermicide, or continuous sexual abstinence as defined by the trial — confirm specific requirements with trial site)
• People considered unsuitable for participation based on the treating doctor's overall medical judgement

Important: Always verify eligibility with the trial site directly before applying.