Glycemia in Diabetic Elders Trial

Johns Hopkins University

Status and phase: Terminated; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Standard Treatment; Drug: Incretin-Based Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02029846

NA_00052707

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

A regimen with traditional drugs only

Treatment:

Drug: Standard Treatment

Incretin-based Treatment

Experimental group

Description:

A regimen including incretin-based drugs

Treatment:

Drug: Incretin-Based Treatment