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 range18 Years
SexALL
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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…
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