Glycemia in Diabetic Elders Trial

April 13, 2023 updated by: Johns Hopkins University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Bay West Endocrinology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Treatment
A regimen with traditional drugs only
Drug: Standard Treatment
traditional drugs only
Other Names:
  • metformin
  • insulin
  • sulfonylureas
  • TZDs
Experimental: Incretin-based Treatment
A regimen including incretin-based drugs
Drug: Incretin-Based Treatment
incretin-based drugs
Other Names:
  • GLP-1 analogues and receptor agonists,
  • DPP-4 inhibitors,
  • amylin analogues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Achieve Glycemic Target (HbA1c <7.5%).
Time Frame: 6 months
Data not analyzed due to n=1 each arm.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Hypoglycemia Measured by Glucose Meter
Time Frame: 6 months
Data not analyzed due to n=1 each arm.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Quality of Life
Time Frame: 6 months
Data not analyzed due to n=1 each arm
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Hsin-Chieh Yeh, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00052707

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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