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Bumetanide

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Oct 17, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

Bumetanide · 1 trial · 1 indication

Phase 1 1
NCT00930865Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy SubjectsType 2 Diabetes Mellitus
COMPLETED42 Analytics
PHASE1COMPLETED
Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
Type 2 Diabetes Mellitus
NCT0093086542
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Study Endpoints

Primary Endpoints

Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
24 hours post-dose on Day 8 and 15

Secondary Endpoints

To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects
during 14 days of dosing
Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone
during 14 days of dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BumetanideACTIVE_COMPARATOR -
DapagliflozinACTIVE_COMPARATOR -
Bumetanide + DapagliflozinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BumetanideDRUGTablets, Oral, 1 mg, Single Dose, 7 Days
DapagliflozinDRUGTablets, Oral, 10 mg. Single Dose, 7 Days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² * Women of childbea...

Countries:United States
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Frequently asked questions about Bumetanide

What is Bumetanide used for in Type 2 Diabetes Mellitus?

Bumetanide is a small molecule being investigated for use in Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development. The drug is being studied for its potential effects when co-administered with dapagliflozin, a treatment for Type 2 Diabetes Mellitus.

What does Bumetanide target?

Bumetanide is a loop diuretic that works by inhibiting the sodium-potassium-chloride cotransporter in the thick ascending limb of the loop of Henle in the kidney. This action increases the excretion of water and electrolytes, which can affect renal parameters relevant to conditions like Type 2 Diabetes Mellitus.

Who makes Bumetanide?

Bumetanide is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's potential in treating Type 2 Diabetes Mellitus.

What phase is Bumetanide in?

Bumetanide is in Phase 1 clinical development for Type 2 Diabetes Mellitus. It is an investigational drug and has not yet been approved for this indication. The Phase 1 trial has been completed, with results expected to inform further development.

What clinical trials is Bumetanide in?

Bumetanide has one completed Phase 1 clinical trial with the identifier NCT00930865. This study evaluated the potential pharmacokinetic interaction and pharmacodynamic effects on renal parameters of bumetanide (1mg) and dapagliflozin (10mg) when co-administered in healthy subjects. The trial enrolled 42 participants in the United States.

Is Bumetanide the same as Dapagliflozin?

No, Bumetanide is not the same as dapagliflozin. Bumetanide is a loop diuretic, while dapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor. They are being studied together in a clinical trial to evaluate potential interactions when co-administered in healthy subjects.