Study S000791

A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT02229396
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: COMPLETED
Enrollment: 695
Start: 2014-09-04
Primary completion: 2016-04-26
Lead sponsor: AstraZeneca
Conditions: Diabetes Mellitus
Interventions: DRUG:Exantide with Dapagliflozin; DRUG:Exentide; DRUG:Dapagliflozin
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2014-003503-29; NIH:2014

Registered primary outcomes

Change in HbA1c From Baseline to Week 28 [Baseline to Week 28]

Linked records (8)

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
R0013562	Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Guja C, Diabetes therapy : research, treatment and education of diabetes and related disorders	2020	Other trial	PMID 32306296 DOI	cites ClinicalTrials.gov:NCT02229396; registry reference DERIVED:32306296
R0023247	Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial. Jabbour SA, Diabetes care	2020	Randomized trial	PMID 32816874 DOI	cites ClinicalTrials.gov:NCT02229396; registry reference DERIVED:32816874
R0024478	Safety and Efficacy of Exenatide Once Weekly Plus Dapagliflozin Once Daily Versus Exenatide or Dapagliflozin Alone in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy: 52-Week Results of the DURATION-8 Randomized Controlled Trial. Jabbour SA, Diabetes care	2018	Randomized trial	PMID 30082326 DOI	cites ClinicalTrials.gov:NCT02229396; registry reference DERIVED:30082326
R0049934	1-Jahresergebnisse der randomisierten, kontrollierten Duration-8-Studie: Wirksamkeit und Verträglichkeit von Depot-Exenatide in Kombination mit täglichem Dapagliflozin gegenüber Monotherapie mit Depot-Exenatide oder Dapagliflozin Cristian Guja, Diabetologie und Stoffwechsel	2018	Other	DOI	cites ClinicalTrials.gov:NCT02229396
R0053226	Duration-8-Studie: Mechanismen der glykämischen Kontrolle unter Depot-Exenatide+Dapagliflozin im Vergleich zu den Einzelsubstanzen Ele Ferrannini, Diabetologie und Stoffwechsel	2018	Other	DOI	cites ClinicalTrials.gov:NCT02229396
R0054967	DURATION-8 Randomized Controlled Trial 104-Week Results—Once-Weekly Exenatide (ExQW) plus Once-Daily Dapagliflozin (DAPA) vs. ExQW or DAPA Alone Serge A Jabbour, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02229396
R0047704	Exenatide einmal wöchentlich plus Dapagliflozin einmal täglich versus Exenatide oder Dapagliflozin allein bei Patienten mit Typ 2 Diabetes, für die eine Metformin-Monotherapie nicht ausreichend war (DURATION-8): Eine 28-wöchige, multizentrische, doppelblinde, randomisierte, kontrollierte Phase-3-Studie Juan P. Frías, Diabetologie und Stoffwechsel	2017	Other	DOI	cites ClinicalTrials.gov:NCT02229396
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	cites ClinicalTrials.gov:NCT02229396; registry reference DERIVED:27651331