Glycemia in Diabetic Elders Trial
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Standard Treatment (insulin, metformin, sulfonylureas, TZDs) Drug: Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues) |
Phase | Phase 4 |
Sponsor | Johns Hopkins University |
Responsible Party | Johns Hopkins University |
ClinicalTrials.gov Identifier | NCT02029846 |
First Received | January 6, 2014 |
Last Updated | January 7, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 6, 2014 |
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Last Updated Date | January 7, 2014 |
Start Date | April 2013 |
Estimated Primary Completion Date | June 2014 |
Current Primary Outcome Measures | Time to achieve glycemic target (HbA1c <7.5%). [Time Frame: 6 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Overall hypoglycemia measured by glucose meter [Time Frame: 6 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Glycemia in Diabetic Elders Trial |
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Official Title | Glycemia in Diabetic Elders Trial |
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 Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Standard Treatment (insulin, metformin, sulfonylureas, TZDs) traditional drugs only Other Names:
incretin-based drugs Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Enrolling by invitation |
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Estimated Enrollment | 30 |
Estimated Completion Date | June 2014 |
Estimated Primary Completion Date | June 2014 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 65 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02029846 |
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Other Study ID Numbers | NA_00052707 |
Has Data Monitoring Committee | No |
Information Provided By | Johns Hopkins University |
Study Sponsor | Johns Hopkins University |
Collaborators | Not Provided |
Investigators | Principal Investigator: Hsin-Chieh Yeh, PhD Johns Hopkins University |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Bay West Endocrinology Associates | Baltimore, Maryland, United States, 21204 |
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