Glycemia in Diabetic Elders Trial

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Glycemia in Diabetic Elders Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029846
• Other study ID #: NA_00052707
• Status: Terminated
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: February 2017

Study information

• Verified date: February 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Standard Treatment
traditional drugs only
• Incretin-Based Treatment
incretin-based drugs

Locations

Country	Name	City	State
United States	Bay West Endocrinology Associates	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diabetes Quality of Life	Data not analyzed due to n=1 each arm	6 months
Primary	Time to Achieve Glycemic Target (HbA1c <7.5%).	Data not analyzed due to n=1 each arm.	6 months
Secondary	Overall Hypoglycemia Measured by Glucose Meter	Data not analyzed due to n=1 each arm.	6 months