Glycemia in Diabetic Elders Trial

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2017

Interventions

  • Drug: Standard Treatment
    • traditional drugs only
  • Drug: Incretin-Based Treatment
    • incretin-based drugs

Arms, Groups and Cohorts

  • Active Comparator: Standard Treatment
    • A regimen with traditional drugs only
  • Experimental: Incretin-based Treatment
    • A regimen including incretin-based drugs

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hsin-Chieh Yeh, PhD, Principal Investigator, Johns Hopkins University

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