NCT02083133

Brief Summary

The purpose of this study is to assess whether the current recommendation for a 50% dose reduction in insulin for diabetic patients with a creatinine clearance (CrCl) ≤15 mL/min or on hemodialysis results in an increased number of hypoglycemic episodes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2017

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

March 7, 2014

Last Update Submit

June 16, 2023

Conditions

DiabetesHypoglycemiaRenal DysfunctionInsulin Dosing

Keywords

DiabetesRenal FailureDialysisEnd Stage Renal DiseaseHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia

    Last 5 years

Study Arms (3)

End Stage Renal Disease

GFR 15 ml/min or less or on Dialysis

Chronic Kidney Disease Stage 4

GFR 15-30 ml/min

Chronic Kidney Disease Stage -3

GFR 30-60 ml/min

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In patient hospitalized greater than or equal to three days, diabetic with CKD 3-5 or on dialysis on insulin therapy

You may qualify if:

  • Inpatient men and women 18 years of age and older with a diagnosis of type 2 diabetes mellitus (T2DM) with CrCl ≥60, 16-59 or ≤15 milliliters/minute.

You may not qualify if:

  • Patients less than 18 years of age, pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypoglycemiaRenal InsufficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pete Antonopoulos, PharmD

    Cook County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist- Principal Investigator

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

October 1, 2013

Primary Completion

January 15, 2017

Study Completion

May 17, 2017

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

US(1)