Xigduo (dapagliflozin and metformin extended-release) / AstraZeneca - LARVOL DELTA

A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting. (clinicaltrials.gov) - P1 | N=58 | Completed | Sponsor: LG Chem | Active, not recruiting ➔ Completed

Trial completion

Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome (clinicaltrials.gov) - P3 | N=200 | Completed | Sponsor: Beni-Suef University | N=500 ➔ 200 | Trial completion date: Dec 2024 ➔ Apr 2026 | Trial primary completion date: Dec 2024 ➔ Mar 2026 | Not yet recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Polyendocrine Metabolic Ovarian Syndrome

A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes (clinicaltrials.gov) - P3 | N=815 | Active, not recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

1019/25: Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the comparative bioavailability of Test Product Dapagliflozin/metformin hydrochloride 5 mg/1000 mg film-coated tablets to Reference Product Xigduo 5 mg/1000 mg film-coated tablets in healthy adult male and female subjects under fed conditions. (clinicaltrialsregister.eu) - P1 | N=32 | Completed | Sponsor: Laboratorios Cinfa S.A.

New P1 trial

A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting. (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: LG Chem

New P1 trial

A Clinical Study to See How the Body Handles and How Safe a Combination Tablet of Gemigliptin, Dapagliflozin, and Metformin 50/10/1000mg is Compared to Taking Gemigliptin 50mg Separately With Dapagliflozin/Metformin 10/1000mg in Healthy Adults After a Meal (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: LG Chem

New P1 trial

Study protocol of a multicenter, randomized, non-inferiority, open-label study investigating the efficacy of a fixed-dose combination regimen of dapagliflozin/metformin versus co-administered dual therapy based on glycemic control, satisfaction and adherence in patients with newly diagnosed type 2 diabetes mellitus. (PubMed, Front Endocrinol (Lausanne)) - "This study, as the first of its kind, will provide comparative data on the efficacy of the dapagliflozin/metformin XR FDC and co-administration of dapagliflozin and metformin XR in terms of glycemic control, patient satisfaction, quality of life and adherence. These data will help clinicians make more informed decisions for patients with type 2 diabetes and may improve medication burden, treatment adherence, and satisfaction."

Clinical protocol • Head-to-Head • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Comparison chart: Sodium-glucose cotransporter 2 (SGLT2) inhibitors. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Noninsulin drugs for type 2 diabetes. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM (clinicaltrials.gov) - P4 | N=633 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes (clinicaltrials.gov) - P3 | N=815 | Enrolling by invitation | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes (clinicaltrials.gov) - P3 | N=815 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM (clinicaltrials.gov) - P4 | N=632 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Beni-Suef University

New P3 trial • Polycystic Ovary Syndrome

Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM (clinicaltrials.gov) - P4 | N=632 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Adherence • Enrollment open • Head-to-Head • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Cost-Effectiveness Analysis of Xigduo (EXTENDED-RELEASE DAPAGLIFLOZIN-METFORMIN TABLETS) for Managing Type 2 Diabetes Mellitus (T2DM) Patients (ISPOR 2024) - "Under the scenario where the National Reimbursement Drug List threshold is set at half of the per capita GDP for the year 2022, Xigduo not only demonstrates cost-effectiveness but also stands out for its absolute economic advantage compared to Dapagliflozin monotherapy or free-dose combination. This finding suggests that Xigduo could be a more viable and economically advantageous treatment option for T2DM in the Chinese healthcare setting, especially considering the economic constraints and healthcare priorities of the country."

Clinical • Cost effectiveness • HEOR • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM (clinicaltrials.gov) - P4 | N=632 | Not yet recruiting | Sponsor: AstraZeneca

Adherence • Head-to-Head • New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration (clinicaltrials.gov) - P4 | N=72 | Completed | Sponsor: The University of Texas Health Science Center at San Antonio | N=23 ➔ 72

Enrollment change • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Farxiga on Renal Function and Size in Type 2 Diabetic Patients With Hyperfiltration (clinicaltrials.gov) - P4 | N=23 | Completed | Sponsor: The University of Texas Health Science Center at San Antonio | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Jul 2023

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetic Variables of Dapagliflozin/Metformin Extended-Release Fixed-Dose Combination in Healthy Chinese Volunteers and Regional Comparison. (PubMed, Clin Ther) - P1 | "The bioequivalence of the dapagliflozin/metformin FDC and IC formulations in healthy Chinese adults was established without any new safety concerns. Notably, the observed bioequivalence may be extrapolated to patients with T2DM as the PK parameters of dapagliflozin and metformin in healthy adults are similar to those reported in patients with T2DM."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects. (PubMed, Transl Clin Pharmacol) - "Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. All treatments were well tolerated. Clinical Research Information Service Identifier: KCT0004026."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Xigduo XR approved in China for adults with type-2 diabetes (AstraZeneca Press Release) - "AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control....The approval by China’s NMPA was based on a local bioequivalence study..."

Non-US regulatory • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

EPIK-B4: Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant (clinicaltrials.gov) - P2 | N=2 | Terminated | Sponsor: Novartis Pharmaceuticals | Active, not recruiting ➔ Terminated; Study was early terminated due to slow recruitment and emerging data showing that prophylactic use of metformin may prevent or reduce the incidence of all-grades alpelisib-related hyperglycemia. The decision was not driven by safety concerns

Combination therapy • Metastases • Trial termination • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • PGR • PIK3CA

of Sodium Glucose Cotransporter-2 Inhibitors on Metabolic, Hormonal and Clinical Parameters in PCO (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Beni-Suef University | Trial primary completion date: Apr 2023 ➔ Jul 2023

Trial primary completion date • Infertility • Polycystic Ovary Syndrome

Xigduo and Metformin an Acidotic Cocktail for the Kidney (ATS 2023) - "Especially now, that new antidiabetic drugs are entering the market. Extensive research of potential side effects is imperative."

Acute Kidney Injury • Critical care • Diabetes • Diabetic Nephropathy • Hypoglycemia • Metabolic Disorders • Nephrology • Pain • Renal Disease • Type 2 Diabetes Mellitus