Glycemia in Diabetic Elders Trial

NCT02029846 | Terminated Phase 4 Results

• 1 other identifier: NA_00052707
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Data not analyzed due to n=1 each arm.

  6 months

Secondary Outcomes (1)

• Overall Hypoglycemia Measured by Glucose Meter

  6 months

Other Outcomes (1)

• Diabetes Quality of Life

  6 months

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

A regimen with traditional drugs only

Drug: Standard Treatment

Incretin-based Treatment

EXPERIMENTAL

A regimen including incretin-based drugs

Drug: Incretin-Based Treatment

Interventions

Standard Treatment DRUG

traditional drugs only

Also known as: insulin, metformin, sulfonylureas, TZDs

Standard Treatment

Incretin-Based Treatment DRUG

incretin-based drugs

Also known as: GLP-1 analogues and receptor agonists,, DPP-4 inhibitors,, amylin analogues

Incretin-based Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Bay West Endocrinology Associates

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin; Metformin; Sulfonylurea Compounds; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Hsin-Chieh Yeh
• Organization: Johns Hopkins University

hyeh1@jhmi.edu

410-614-4316

Study Officials

• Hsin-Chieh Yeh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: April 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 18, 2023
• Results First Posted: May 25, 2017

Record last verified: 2018-02

Locations

US (1)