Glycemia in Diabetic Elders Trial

Phase 4TerminatedNCT02029846

Johns Hopkins University2 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

Standard TreatmentDRUG

traditional drugs only

Incretin-Based TreatmentDRUG

incretin-based drugs

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Bay West Endocrinology Associates

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Time to Achieve Glycemic Target (HbA1c <7.5%).

Data not analyzed due to n=1 each arm.

Time frame: 6 months

Secondary Outcomes

Overall Hypoglycemia Measured by Glucose Meter

Data not analyzed due to n=1 each arm.

Time frame: 6 months

Data from ClinicalTrials.gov

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