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Exantide with Dapagliflozin

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Trials Updated: Dec 31, 2018

Exantide with Dapagliflozin development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment695

FDA Designations

No designations recorded

Exantide with Dapagliflozin clinical trials

Exantide with Dapagliflozin · 1 trial · 1 indication

Phase 3 1
NCT02229396Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching PlaceboDiabetes Mellitus
COMPLETED695 Analytics
PHASE3COMPLETED
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

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

To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.

Secondary Endpoints

Change in Body Weight From Baseline to Week 28
Baseline to Week 28
Change in Fasting Plasma Glucose From Baseline to Week 28
Baseline to Week 28
Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test
Baseline to Week 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mgEXPERIMENTAL -
Exenatide Once Weekly 2 mg AloneEXPERIMENTAL -
Dapagliflozin Once Daily 10 mg AloneACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Exantide with DapagliflozinDRUG2 mg weekly suspension injection and 10 mg Dapagliflozin
ExentideDRUG2 mg
DapagliflozinDRUG10 mg once daily Dapagliflozin
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites133

Inclusion criteria * Has a diagnosis of T2DM. * Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2. * Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening. Exclusion criteria * FPG ≥280 mg/dL (15.6 mmol/L). * Serum calcitonin concentration ≥40 p...

Countries:United StatesHungaryPolandRomaniaSlovakiaSouth Africa
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Frequently asked questions about Exantide with Dapagliflozin

What is Exantide with Dapagliflozin?

Exantide with Dapagliflozin is an investigational combination therapy being developed by AstraZeneca PLC for the treatment of Diabetes Mellitus. It pairs a peptide-based agent with dapagliflozin and has been studied in a Phase 3 clinical trial. The combination remains in clinical development and is not described as approved.

What is Exantide with Dapagliflozin used for in Diabetes Mellitus?

Exantide with Dapagliflozin is being studied for the treatment of Diabetes Mellitus. The Phase 3 trial evaluated the combination in adults with this condition. It is an investigational therapy, and its use is limited to clinical research at this stage.

Who is developing Exantide with Dapagliflozin?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of Exantide with Dapagliflozin. The company is responsible for the clinical program evaluating this combination therapy in Diabetes Mellitus.

What phase is Exantide with Dapagliflozin in?

Exantide with Dapagliflozin is in Phase 3 development. One Phase 3 trial has been completed, and no active trials are currently listed. The therapy remains investigational and has not been described as approved.

What clinical trials is Exantide with Dapagliflozin in?

Exantide with Dapagliflozin has been studied in one completed Phase 3 trial, NCT02229396. This randomized, double-blind, active-controlled study enrolled 695 participants across the United States, Hungary, Poland, Romania, Slovakia, and South Africa, and included 28-week, 24-week, and 52-week extension phases.