Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
NCT03795389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2021-09-13
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.
Conditions
- Chronic Kidney Disease
- Chronic Kidney Disease, Stage 3 (Moderate)
- Chronic Kidney Disease, Stage 4 (Severe)
- Diabetes
Interventions
- DRUG
-
DM199
Single SC dose
Sponsors & Collaborators
-
DiaMedica Therapeutics Inc
lead INDUSTRY
Principal Investigators
-
Harry Alcorn, Pharm.D. · DiaMedica Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-12
- Primary Completion
- 2019-07-21
- Completion
- 2019-07-21
- FDA Drug
- Yes
Countries
- United States
Study Locations
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