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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
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 6, 2014
Last Updated
April 13, 2023
Sponsor
Johns Hopkins University
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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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