NCT03795389

Study to Assess PK, Safety and Tolerability in Patients With DM and CKD

A Multi-Center Open-label Investigation to Assess the Pharmacokinetics, Safety and Tolerability of DM199 in Patients With Diabetes Mellitus and Chronic Kidney Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: DiaMedica Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study evaluates the safety, tolerability, and PK profile of DM199 in subjects with T1D or T2D and with Stage 3 or Stage 4 CKD. Additionally, this study evaluates urine concentrations of KLK1 pre and post dose. Cohort 1: Subjects with T1D or T2D and Stage 3 CKD will be administered one of three DM199 doses: 3.0 ug/kg or 5.0 ug/kg or 8.0 ug/kg single SC dose. Cohort 2: Subjects with T1D or T2D and Stage 4 CKD will be administered a single 3.0 µg/kg single SC dose. Secondary and exploratory study objectives include collection and analysis of vital signs, biomarkers, eGFR, blood glucose, and ECG's.

Conditions

• Chronic Kidney Disease
• Chronic Kidney Disease, Stage 3 (Moderate)
• Chronic Kidney Disease, Stage 4 (Severe)
• Diabetes

Interventions

Type	Name	Description
DRUG	DM199	Single SC dose

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-07-21
• Completion: 2019-07-21
• First posted: 2019-01-07
• Last updated: 2021-09-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study