Glycemia in Diabetic Elders Trial

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Standard Treatment (insulin, metformin, sulfonylureas, TZDs)
Drug: Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues)
PhasePhase 4
SponsorJohns Hopkins University
Responsible PartyJohns Hopkins University
ClinicalTrials.gov IdentifierNCT02029846
First ReceivedJanuary 6, 2014
Last UpdatedJanuary 7, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateJanuary 6, 2014
Last Updated DateJanuary 7, 2014
Start DateApril 2013
Estimated Primary Completion DateJune 2014
Current Primary Outcome MeasuresTime to achieve glycemic target (HbA1c <7.5%). [Time Frame: 6 months] [Designated as safety issue: No]
Current Secondary Outcome MeasuresOverall hypoglycemia measured by glucose meter [Time Frame: 6 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleGlycemia in Diabetic Elders Trial
Official TitleGlycemia in Diabetic Elders Trial
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Standard Treatment (insulin, metformin, sulfonylureas, TZDs)
traditional drugs only
Other Names:
  • insulin
  • metformin
  • sulfonylureas
  • TZDs
Drug: Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues)
incretin-based drugs
Other Names:
  • GLP-1 analogues and receptor agonists,
  • DPP-4 inhibitors,
  • amylin analogues
Study Arm (s)
  • Active Comparator: Standard Treatment
    A regimen with traditional drugs only
  • Experimental: Incretin-based Treatment
    A regimen including incretin-based drugs

Recruitment Information[ + expand ][ + ]

Recruitment StatusEnrolling by invitation
Estimated Enrollment30
Estimated Completion DateJune 2014
Estimated Primary Completion DateJune 2014
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
GenderBoth
Ages65 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02029846
Other Study ID NumbersNA_00052707
Has Data Monitoring CommitteeNo
Information Provided ByJohns Hopkins University
Study SponsorJohns Hopkins University
CollaboratorsNot Provided
Investigators Principal Investigator: Hsin-Chieh Yeh, PhD Johns Hopkins University
Verification DateJanuary 2014

Locations[ + expand ][ + ]

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