Study S002223

A 28-week, Multi-center Randomized, Double-blind, Placebo-controlled Study to Evaluate the Potential of Dapagliflozin Plus Exenatide in Combination With High-dose Intensive Insulin Therapy Compared to Placebo in Obese Insulin-resistant Patients With Type 2 Diabetes Mellitus (Proof-of-concept Study)

ClinicalTrials.gov record

Registration

Registration: NCT03419624
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: TERMINATED
Enrollment: 13
Start: 2018-02-19
Primary completion: 2019-04-01
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Conditions: Obesity; Diabetes Mellitus, Type 2
Interventions: DRUG:Dapagliflozin 10mg; DRUG:Exenatide 2 mg [Bydureon]; DRUG:Placebo Oral Tablet; DRUG:Placebo injection; DRUG:Insulin; DRUG:Metformin, if taken before
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in HbA1c from baseline (week 0) to week 28 [28 weeks]

Linked records (5)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0021793	Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Frías JP, The lancet. Diabetes & endocrinology	2016	Randomized trial	PMID 27651331 DOI	registry reference BACKGROUND:27651331
R0015624	A clinical review of GLP-1 receptor agonists: efficacy and safety in diabetes and beyond. Prasad-Reddy L, Drugs in context	2015	Narrative review	PMID 26213556 DOI	registry reference BACKGROUND:26213556
R0025907	Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice. Tatarkiewicz K, Diabetes, obesity & metabolism	2014	Preclinical	PMID 24251534 DOI	registry reference BACKGROUND:24251534
R0027649	DURATION-5: exenatide once weekly resulted in greater improvements in glycemic control compared with exenatide twice daily in patients with type 2 diabetes. Blevins T, The Journal of clinical endocrinology and metabolism	2011	Randomized trial	PMID 21307137 DOI	registry reference BACKGROUND:21307137
R0027273	Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Diamant M, Lancet (London, England)	2010	Randomized trial	PMID 20609969 DOI	registry reference BACKGROUND:20609969