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NCT02917057
Subanalyses of Elderly Type 2 Diabetes Patients or Type 2 Diabetes Patients With Renal Impairment
trial testing exenatide once weekly in Type 2 Diabetes in 6,024 participants. Completed in 1 August 2015.
1 August 2015
Quick facts
| Lead sponsor | AstraZeneca |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 6,024 |
| Start date | 1 August 2015 |
| Primary completion | 1 August 2015 |
| Estimated completion | 1 August 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- exenatide once weekly — full drug profile →
- basal insulin — full drug profile →
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
AstraZeneca — full company profile →
Who can join
Eligibility, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02917057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT02974244 — Comparison of the Effectiveness and Tolerability of Exenatide Once-weekly Compared to Basal Insulins · completed
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Currently open trials in the same condition.
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Other AstraZeneca trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02917057 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
- Last refreshed: 29 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02917057.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing