dapagliflozin/sitagliptin / AstraZeneca - LARVOL DELTA

Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial. (PubMed, Adv Ther) - "Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile."

Journal • Monotherapy • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Racial Comparison of the Pharmacokinetics and Safety of Fixed-Dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. (PubMed, Clin Ther) - P1 | "The 10 mg dapagliflozin/100 mg sitagliptin FDC and IC formulations were bioequivalent in fasted healthy Western and Korean participants, with no new safety concerns identified, thus offering a useful alternative for patients currently receiving individual medications as part of their treatment regimen."

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

Triple-Arm, Prospective, Multicentre, Randomized, Open-Label, Active-Controlled Study to Assess Effect on FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg Compared with FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg and FDC of Linagliptin 5 mg+ Empagliflozin 25 mg on 24-Hour Glucose . (ADA 2024) - "FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg & FDC of Linagliptin 5 mg + Empagliflozin 25 mg had significant improvement in CGM & Glycemic parameters."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Use of DPP4i/SGLT2i Fixed Dose Combinations in Indian Clinical Practice—A KAP Survey (ADA 2024) - "Most favored FDC was Sitagliptin/Dapagliflozin (36%, n=67). In India there is significant burden of patients with T2DM who present with high HbA1c (newly diagnosed or despite metformin monotherapy). Generic DPP4i/SGLT2i FDCs are preferred in these patients also considering their extra-glycemic benefits. Most physicians (85%) noted reduction in SGLT2i associated GUTIs with use of DPP4i/SGLT2i FDCs."

Clinical • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Retrospective Observational Study on Assessing Sitagliptin and Dapagliflozin as a Fixed-Dose Combination in the Indian Population With Type 2 Diabetes Mellitus: The SIDAXA Study. (PubMed, Cureus) - "Metformin (n=282, 85.98%) and sulfonylurea (n=134, 40.85%) were commonly prescribed concomitant oral antidiabetic agents (OADs). Conclusion The FDC of sitagliptin and dapagliflozin significantly improved glycaemic control and lipid profiles in T2DM patients, particularly those with coronary artery disease. It demonstrated a favourable safety profile in the Indian population, signifying its potential as an effective and well-tolerated therapeutic option in patients with established cardiovascular disease."

Journal • Observational data • Retrospective data • Cardiovascular • Coronary Artery Disease • Diabetes • Dyslipidemia • Hypertension • Infectious Disease • Metabolic Disorders • Mycosis Fungoides • Pain • Type 2 Diabetes Mellitus

Study on Effectiveness in Real-world with Dapagliflozin and Sitagliptin Fixed dose combination in patients with Type 2 Diabetes Mellitus in India: Retrospective Study from Electronic Medical Records (AACE 2024) - "The combination was also effective in significantly reducing body weight. Thus, FDC of dapagliflozin + sitagliptin was shown to be effective treatment option in patients with T2DM in real-world setting."

Real-world • Real-world evidence • Retrospective data • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Real DAPSI: A Real-World Retrospective Study on Assessing the Efficacy and Safety of a Fixed-Dose Combination of Dapagliflozin and Sitagliptin in the Indian Population. (PubMed, Cureus) - "These findings highlight the potential benefits of this combination therapy in managing T2DM and pave the way for optimized treatment strategies and improved patient outcomes in the Indian healthcare landscape. Clinicians may consider dapagliflozin-sitagliptin FDC as a viable treatment option for T2DM patients."

Journal • Real-world • Real-world evidence • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Exploring the Perceived Value of Fixed-Dose Combinations in Type 2 Diabetes Mellitus in the EU4 and the UK (ISPOR-EU 2023) - " Four FDCs consisting of metformin + dapagliflozin (A), sitagliptin (B), vildagliptin (C) and sitagliptin (D) were analyzed. The moderate market share of 3 out of 4 FDCs between 2018 to 2022, indicates that among physicians there might be a low awareness of the benefits of improving adherence and simplified therapy with price also playing a role."

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Fixed-Dose Combination of Dapagliflozin + Sitagliptin + Metformin in Patients with Type 2 Diabetes Poorly Controlled with Metformin: Phase 3, Randomized Comparison with Dual Combinations. (PubMed, Adv Ther) - "Triple FDC of DAPA + SITA + MET ER tablets once daily was significantly better in achieving glycemic control versus dual combination once daily in patients with type 2 diabetes poorly controlled with metformin without any significant safety concerns."

Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Development of Clinically Optimized Sitagliptin and Dapagliflozin Complex Tablets: Pre-Formulation, Formulation, and Human Bioequivalence Studies. (PubMed, Pharmaceutics) - "In the human clinical trial, we co-administered a single dose of a sitagliptin phosphate monohydrate-dapagliflozin propanediol hydrate FDC double-layered tablet and the reference drug (Forxiga, Januvia) in healthy adult volunteers. This study showed clinically equivalent results in the stability and pharmacodynamic characteristics between the two groups."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Phase 1 Bioequivalence Study of Dapagliflozin/Sitagliptin FDC vs Loose Combination of Single Components (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed | N=27 ➔ 46

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

A Pharmacokinetic Study of DW6012 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: Dong Wha Pharmaceutical Co. Ltd.

New P1 trial