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Placebo for dapagliflozin

DRUG6 trials

Sponsors

Winicker-Norimed Medizinische Forschung GmbH, Klinikum Nuernberg, Universitaetsklinikum Schleswig-Holstein AöR, AstraZeneca

Conditions

Arterial HypertensionInadequate Glycaemic ControlStage 3 chronic kidney diseaseType 1 Diabetes MellitusType 2 Diabetes Mellitus

Phase 2

A study to investigate the mechanistic effects of dapagliflozin alone or in combination with balcinrenone, compared to balcinrenone and placebo on body fluid and electrolyte handling and energy metabolism in participants over 50 years of age with chronic kidney disease (DapaBalci-Leap)
RecruitingCTIS2024-516032-10-00
Winicker-Norimed Medizinische Forschung GmbH, Klinikum NuernbergStage 3 chronic kidney disease
Start: 2023-07-13Target: 150Updated: 2025-12-01

Phase 3

Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
CompletedNCT02268214
AstraZenecaType 1 Diabetes Mellitus
Start: 2014-11-11End: 2017-08-25Updated: 2018-09-13
Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes
CompletedNCT02460978
AstraZenecaType 1 Diabetes Mellitus
Start: 2015-07-08End: 2018-04-18Updated: 2019-03-05
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
CompletedNCT02681094
AstraZenecaInadequate Glycaemic Control, Type 2 Diabetes Mellitus
Start: 2016-02-26End: 2017-07-15Updated: 2018-10-10
SGLT2 INHIBITION FOR CARDIOVASCULAR ENDPOINT REDUCTION IN HYPERTENSION
Not yet recruitingCTIS2025-520794-39-00
Universitaetsklinikum Schleswig-Holstein AöRArterial Hypertension
Target: 3112Updated: 2026-01-15

Phase 4

Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
CompletedNCT02471404
AstraZenecaInadequate Glycaemic Control, Type 2 Diabetes Mellitus
Start: 2015-09-21End: 2017-03-13Updated: 2019-03-26

Related Papers

Effectiveness of dapagliflozin as an insulin adjunct in type 1 diabetes: a semi-mechanistic exposure-response model
Frontiers in Pharmacology2023-10-25
Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus
The Journal of Clinical Pharmacology2022-04-117 citations
Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials.
2020-10-0156 citations
Benefit/risk profile of dapagliflozin 5 mg in the <scp>DEPICT</scp> ‐1 and ‐2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m <sup>2</sup>
Diabetes Obesity and Metabolism2020-07-2128 citations
1231-P: Dapagliflozin (DAPA) in Type 1 Diabetes (T1D): Pooled Outcomes from DEPICT-1 and -2
Diabetes2019-06-013 citations
Triple therapy with low‐dose dapagliflozin plus saxagliptin versus dual therapy with each monocomponent, all added to metformin, in uncontrolled type 2 diabetes
Diabetes Obesity and Metabolism2019-05-3025 citations
Model‐based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus
Diabetes Obesity and Metabolism2019-02-139 citations
Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study
Diabetes Care2018-10-23228 citations
Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized Controlled Trial
Diabetes Care2018-07-19245 citations
Efficacy and safety of dapagliflozin or dapagliflozin plus saxagliptin versus glimepiride as add-on to metformin in patients with type 2 diabetes.
2018-07-1648 citations
Efficacy and Safety of Dapagliflozin in Patients with Inadequately Controlled Type 1 Diabetes—DEPICT-2 Study
Diabetes2018-06-2213 citations
Dose-Response and Exposure-Response (HbA1c) of Dapagliflozin in T1DM Patients
Diabetes2018-06-225 citations
Triple vs. Dual Therapy with Low-Dose Dapagliflozin plus Saxagliptin vs. Each Monocomponent Added to Metformin in Uncontrolled Type 2 Diabetes
Diabetes2018-06-221 citations
Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial.
2017-09-14226 citations