Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial… (NCT04877366) | Clinical Trial Compass
CompletedNot Applicable
Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia
United States, Singapore30 participantsStarted 2021-07-21
Plain-language summary
This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to sign written informed consent prior to study entry.
* Participants who self-identify as Asian; male or female, \>18 years of age.
* Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes).
* Treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
* Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
* Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
Exclusion Criteria:
* Fasting plasma glucose \>220 mg/dl at screening.
* Impaired kidney function, eGFR of \<60 mL/min/1.73 m2 at screening.
* BMI \>35 kg/m2.
* Weight ≤ 50 kg.
* Elevated liver transaminase \> 3 ULN at screening.
* Ongoing or recent (i.e. \< 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin.
* Ongoing or recent (i.e. \< 3 month) injectable insulin therapy.
* Ongoing or recent (i.e. \< 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss \>5% within previous 6 months.
* Ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-inte…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.