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New treatment option for Diabetes Mellitus, Type 2
Official title Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
ClinicalTrials.gov ID: NCT03264352
What this study is testing
What is Allisartan Isoproxil?
Allisartan Isoproxil is an investigational medicine, given as an once-daily, being studied as a potential treatment for diabetes mellitus, type 2.
Also referred to as Xinlitan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 79
You may be able to join if
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
- informed consent provided and long-term follow-up possible
You likely can't join if
- poor control of blood glucose, HbA1c \> 10.0%
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate \< 45 ml/min/1.73m2;
See the full eligibility criteria
- irrespective of sex;
- aged between 45 and 79 years;
- with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;
- diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;
- informed consent provided and long-term follow-up possible
- poor control of blood glucose, HbA1c \> 10.0%
- administration of any antihypertensive medications within 1 month;
- a history of hypoglycemic coma / seizure;
- confirmed diagnosis of type 1 diabetes mellitus;
- alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;
- estimated glomerular filtration rate \< 45 ml/min/1.73m2;
- a history of congestive heart failure with left ventricular ejection fraction \< 40%;
- coronary artery disease requiring RAS blockers for secondary prevention;
- acute on-set of stroke within 6 months prior to randomization;
- a ratio of urinary albumin (in mg/L) to urinary creatinine (in g/L) (ACR) ≥ 300 mg/g;
- known contraindications for the active study medications;
- a history of psychological or mental disorder;
- pregnancy or currently planning to have babies or lactation;
- severe diseases such as severe heart diseases;
- an expected residual life span less than 3 years;
- a malignancy that clinical investigators consider as unsuitable to participate;
- currently participating in another clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.