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Glycemia in Diabetic Elders Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029846
Recruitment Status : Terminated (No sufficient numbers of eligible participants)
First Posted : January 8, 2014
Results First Posted : May 25, 2017
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Standard Treatment Drug: Incretin-Based Treatment Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glycemia in Diabetic Elders Trial
Actual Study Start Date : April 2013
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Treatment
A regimen with traditional drugs only
 Drug: Standard Treatment
traditional drugs only
Other Names:
  • insulin
  • metformin
  • 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


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


Secondary Outcome Measures :
  1. Overall Hypoglycemia Measured by Glucose Meter [ Time Frame: 6 months ]
    Data not analyzed due to n=1 each arm.


Other Outcome Measures:
  1. Diabetes Quality of Life [ Time Frame: 6 months ]
    Data not analyzed due to n=1 each arm


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029846


Locations
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United States, Maryland
Bay West Endocrinology Associates
Baltimore, Maryland, United States, 21204
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Hsin-Chieh Yeh, PhD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Study Protocol and Statistical Analysis Plan  [PDF] June 11, 2013

More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02029846    
Other Study ID Numbers: NA_00052707
First Posted: January 8, 2014    Key Record Dates
Results First Posted: May 25, 2017
Last Update Posted: March 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Dipeptidyl-Peptidase IV Inhibitors
Incretins
 Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists