NCT03795389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

September 13, 2021

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

January 3, 2019

Last Update Submit

September 3, 2021

Conditions

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

Keywords

DiabetesChronic Kidney Disease

Outcome Measures

Primary Outcomes (4)

  • Safety as assessed by incidence, severity, and causality of adverse events

    11 days

  • Tolerability as assessed by incidence and severity of AEs

    11 days

  • plasma measurements of DM199

    as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg.

    11 days

  • DM199 urine concentrations of KLK1

    urine KLK1 will be measured pre and post study drug administration.

    11 days

Secondary Outcomes (8)

  • C Reactive protein (CRP)

    11 days

  • Matrix Metalloproteinase-9 (MMP-9)

    11 days

  • Vascular Endothelial Growth Factor (VEGF)

    11 days

  • Nitric Oxide (NO)

    11 days

  • Serum creatinine

    11 days

  • +3 more secondary outcomes

Other Outcomes (2)

  • serum creatinine

    11 days

  • Blood glucose

    11 days

Study Arms (3)

3.0 µg/kg SC, single dose

EXPERIMENTAL

n=8, study group of T1D or T2D with stage 3 CKD. separate n=8 of study group with T1D or T2D with CKD stage 4).

Drug: DM199

5.0 µg/kg SC, single dose

EXPERIMENTAL

n=8, study group of T1D or T2D with stage 3 CKD.

Drug: DM199

8.0 µg/kg SC, single dose

EXPERIMENTAL

n=8, study group of T1D or T2D with stage 3 CKD.

Drug: DM199

Interventions

DM199DRUG

Single SC dose

3.0 µg/kg SC, single dose5.0 µg/kg SC, single dose8.0 µg/kg SC, single dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 malignancy ≤ 3 years prior to enrollment except basal cell or squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy and ≥ six months have elapsed since the procedure.
  • Subject has an active infection at the time of enrollment, and/or a history of clinically significant acute bacterial, viral, or fungal systemic infections that required systemic treatment in the last four weeks prior to enrollment.
  • Subject has known medical history of alpha 1-antitrypsin deficiency (α1-antitrypsin deficiency).
  • Subject has serological evidence of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (Anti-HCV) at screen.
  • Subject is pregnant or nursing or is planning a pregnancy during the study period.
  • Subject is male or female of childbearing potential, is participating in sexual activity that could lead to pregnancy and is unable or unwilling to practice medically effective contraception during the study.
  • Subject has received any investigational drug or device within 14 days (or 5 half lives, whichever is longer) prior to study drug administration on Day 1
  • Subject has renal artery stenosis as determine at screen with medical history.
  • Subject has hypotension as defined by systolic blood pressure ≤ 90 and diastolic blood pressure ≤ 60 mmHg.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Orlando Clinical Research Center Inc

Orlando, Florida, 32803, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicLymphoma, FollicularDiabetes Mellitus

Interventions

DM199

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Harry Alcorn, Pharm.D.

    DiaMedica Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

February 12, 2019

Primary Completion

July 21, 2019

Study Completion

July 21, 2019

Last Updated

September 13, 2021

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)