Glycemia in Diabetic Elders Trial

Phase 4

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Standard Treatment; Drug: Incretin-Based Treatment

• Registration Number: NCT02029846
• Lead Sponsor: Johns Hopkins University

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 Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Results First Submitted: 2017-04-17
• Results First Submitted QC: 2017-04-17
• Results First Posted: 2017-05-25
• Status Verified: 2018-02
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Treatment	A regimen with traditional drugs only
Incretin-based Treatment	Incretin-Based Treatment	A regimen including incretin-based drugs

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bay West Endocrinology Associates; 🇺🇸 Baltimore, Maryland, United States