Glycemia in Diabetic Elders Trial
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment
Incretin-Based Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetics diagnosed for at least 6 months
- Patients ages ≥ 65 years and older
- Active patients in the Bay West Endocrinology practice
- Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
- Eligible for randomization to either treatment group
- Patients willing to follow either treatment arm including regimen using one or more injectables
- Patients to have an English Reading Level of Grade 6 or above
- Patients residing at home
Exclusion Criteria:
- Unwilling to use a regimen that may contain using one or more injections
- Using short acting insulin prior to the study
- Using GLP-1 in past 10 weeks
- History of hypoglycemia unawareness or episodes needing emergency intervention
- End-stage renal disease
- Dementia
- Blindness
- Terminal illness
Sites / Locations
- Bay West Endocrinology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment
Incretin-based Treatment
Arm Description
A regimen with traditional drugs only
A regimen including incretin-based drugs
Outcomes
Primary Outcome Measures
Time to Achieve Glycemic Target (HbA1c <7.5%).
Data not analyzed due to n=1 each arm.
Secondary Outcome Measures
Overall Hypoglycemia Measured by Glucose Meter
Data not analyzed due to n=1 each arm.
Full Information
NCT ID
NCT02029846
First Posted
January 6, 2014
Last Updated
April 13, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02029846
Brief Title
Glycemia in Diabetic Elders Trial
Official Title
Glycemia in Diabetic Elders Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
No sufficient numbers of eligible participants
Study Start Date
April 2013 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
A regimen with traditional drugs only
Arm Title
Incretin-based Treatment
Arm Type
Experimental
Arm Description
A regimen including incretin-based drugs
Intervention Type
Drug
Intervention Name(s)
Standard Treatment
Other Intervention Name(s)
insulin, metformin, sulfonylureas, TZDs
Intervention Description
traditional drugs only
Intervention Type
Drug
Intervention Name(s)
Incretin-Based Treatment
Other Intervention Name(s)
GLP-1 analogues and receptor agonists,, DPP-4 inhibitors,, amylin analogues
Intervention Description
incretin-based drugs
Primary Outcome Measure Information:
Title
Time to Achieve Glycemic Target (HbA1c <7.5%).
Description
Data not analyzed due to n=1 each arm.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Hypoglycemia Measured by Glucose Meter
Description
Data not analyzed due to n=1 each arm.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Diabetes Quality of Life
Description
Data not analyzed due to n=1 each arm
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetics diagnosed for at least 6 months
Patients ages ≥ 65 years and older
Active patients in the Bay West Endocrinology practice
Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
Eligible for randomization to either treatment group
Patients willing to follow either treatment arm including regimen using one or more injectables
Patients to have an English Reading Level of Grade 6 or above
Patients residing at home
Exclusion Criteria:
Unwilling to use a regimen that may contain using one or more injections
Using short acting insulin prior to the study
Using GLP-1 in past 10 weeks
History of hypoglycemia unawareness or episodes needing emergency intervention
End-stage renal disease
Dementia
Blindness
Terminal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Chieh Yeh, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay West Endocrinology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
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Glycemia in Diabetic Elders Trial
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