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NCT02917057 · ClinicalTrials.gov registry record
Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment
A clinical trial of Type 2 Diabetes, sponsored by AstraZeneca.
- Completed
- Registry status
- 6,024
- Enrollment target
- 1
- Study location
NCT02917057 is a study of Type 2 Diabetes that has completed, run by AstraZeneca. The registered enrollment target is 6,024 participants, above the 1,082-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (457% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02917057, a study of Type 2 Diabetes, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 6,024 participants
- Enrollment target
- 1
- Study location
Study Summary
Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other glucagon-like peptide-1 agonists, and appears to have other advantages, such as reducing insulin resistance, reducing weight, and improving blood pressure and lipid profiles. However, the degree to which these advantages of Bydureon lead to improve outcomes in customary clinical care in patients with mild and moderate renal impairment and in elderly patients are unknown. The aim of this study is to evaluate the effectiveness and tolerability of Bydureon relative to basal insulin initiated as first-ever injectable therapeutic regimens among elderly patients and patients with renal impairment. Patients who initiated treatment with Bydureon or basal insulin between July 2011 and March 2015 will be recruited into the study cohorts from Optum's database of electronic health records. The two treatment cohorts will be matched by propensity score method. Changes in HbA1c, weight, markers for renal function (estimated glomerular filtration rate (eGFR), serum creatinine, and albumin/creatinine ratio (ACR)), and incidences of gastrointestinal symptoms and hypoglycaemia are investigated for patients with different eGFR categories and with different ages.
Conditions Studied
Interventions
- DRUG basal insulin
- DRUG exenatide once weekly
Study Locations (1)
Massachusetts
- Optum Epidemiology - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,024 participants |
| Start Date | 2015-08-01 |
| Est. Completion | 2015-08-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02917057
The ClinicalTrials.gov registry entry for NCT02917057 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6,024 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,082-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (457% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which basal insulin is the first listed.
NCT02917057 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02917057 about?
NCT02917057 is a clinical study titled "Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment". Exenatide once weekly (Bydureon) was approved in January 2012 by FDA in USA for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require a dose titration as necessary for other g...
What is the current status of trial NCT02917057?
This trial is currently completed. The enrollment target is 6,024 participants. The study started on 2015-08-01. Estimated completion is 2015-08-01.
What conditions does trial NCT02917057 study?
This clinical trial studies the following conditions: Type 2 Diabetes.
What interventions are being tested in trial NCT02917057?
The interventions under investigation include: basal insulin (DRUG), exenatide once weekly (DRUG).
Who is sponsoring clinical trial NCT02917057?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02917057 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.