Study to Assess PK, Safety and Tolerability in Patients With DM and CKD (NCT03795389) | Clinical Trial Compass
CompletedPhase 1
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
United States33 participantsStarted 2019-02-12
Plain-language summary
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
Who can participate
Age range
18 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:
* Subject is willing and able to provide informed consent for study participation.
* Subject is ≥ 18 years of age.
* Subject has an established diagnosis of T1D or T2D as determined by medical evaluation at screen.
* Subjects A1c \<9.8%
* Subject is clinically stable with respect to underlying renal impairment and diabetes, as assessed by the Investigator's medical evaluation.
* Subject has been diagnosed with Stage 3 CKD as defined by eGFR (MDRD) between 30 - \<60 or Stage 4 as defined by eGFR \<30 (not on dialysis) at screening.
* Subject has a body mass index (BMI) between 18 to 45 kg/m2 (inclusive).
Exclusion Criteria:
* Subject has positive drug test for drugs of abuse and/or positive alcohol breath test at screening and Day 0.
* Subject is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
* Subject has a history of significant allergic diathesis such as urticaria, angioedema, or anaphylaxis.
* Subject has had any live vaccination ≤ 3 months prior to enrollment or will require vaccination during the study.
* Subject must not be taking an ACEi medication for 5 half-lives prior to study drug administration and for 5 days post study drug administration.
* Subject is unwilling or unable to limit smoking to ≤ 10 cigarettes per day (or other products that contain nicotine limited to \< 200 mg of nicotine/day) during the study participation period.
* Subject has a current malignancy or active mal…
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.
What they're measuring
1
Safety as assessed by incidence, severity, and causality of adverse events
Timeframe: 11 days
2
Tolerability as assessed by incidence and severity of AEs