Back to Search
Start Over
Long-term effects of dapagliflozin plus saxagliptin versus glimepiride on a background of metformin in patients with type 2 diabetes: Results of a 104-week extension to a 52-week randomized, phase 3 study and liver fat MRI substudy.
- Source :
-
Diabetes, obesity & metabolism [Diabetes Obes Metab] 2022 Jan; Vol. 24 (1), pp. 61-71. Date of Electronic Publication: 2021 Sep 28. - Publication Year :
- 2022
-
Abstract
- Aim: To report the results of a 104-week extension to a 52-week study in which dapagliflozin plus saxagliptin (DAPA+SAXA) improved glycaemic control, liver fat and metabolic variables compared with glimepiride (GLIM) in participants with type 2 diabetes (T2D) receiving background metformin.<br />Materials and Methods: This extension to a 52-week global, multicentre, parallel-group, active-controlled, double-blind study (NCT02419612) continued randomized participants (1:1) on DAPA+SAXA (10/5 mg) plus placebo, or GLIM (1-6 mg) plus placebo, once daily. Eligible participants were aged ≥18 years, had T2D (glycated haemoglobin [HbA1c] 58.5-91.3 mmol/mol [7.5%-10.5%]), and a body mass index of 20.0 to 45.0 kg/m <superscript>2</superscript> , and were receiving metformin (MET; ≥1500 mg/d). Key outcomes were: requirement for treatment intensification, based on HbA1c ≥53 mmol/mol (7%); achieving therapeutic glycaemic response; and changes in adipose tissue and liver fat on magnetic resonance imaging in a substudy.<br />Results: Overall, 382 participants entered and 338 completed the 104-week extension period (MRI substudy, n = 82). The need for treatment intensification during the 156-week period was lower for DAPA+SAXA+MET (37.0%) than GLIM+MET (55.6%; hazard ratio 0.52, 95% confidence interval [CI] 0.39-0.68; P < 0.001). At week 156, 21.4% of DAPA+SAXA+MET versus 11.7% of GLIM+MET participants achieved therapeutic glycaemic response (HbA1c <53 mmol/mol; odds ratio 2.1, 95% CI 1.23-3.42; P = 0.006). DAPA+SAXA+MET led to greater adjusted mean reductions from baseline in liver fat and visceral and subcutaneous adipose tissue volumes versus GLIM+MET at week 122 (least-squares mean difference from GLIM+MET -4.89%, -0.41 L and -0.44 L, respectively; nominal P values ≤ 0.008). Safety was consistent with that of the monocomponents.<br />Conclusions: Overall, glycaemic control, metabolic benefits and efficacy were better maintained with DAPA+SAXA+MET than with GLIM+MET in T2D.<br /> (© 2021 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Subjects :
- Adamantane analogs & derivatives
Adipose Tissue diagnostic imaging
Adolescent
Adult
Benzhydryl Compounds therapeutic use
Dipeptides
Double-Blind Method
Drug Therapy, Combination adverse effects
Glucosides
Glycated Hemoglobin
Humans
Hypoglycemic Agents adverse effects
Liver diagnostic imaging
Magnetic Resonance Imaging
Sulfonylurea Compounds
Treatment Outcome
Diabetes Mellitus, Type 2 complications
Diabetes Mellitus, Type 2 drug therapy
Metformin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1463-1326
- Volume :
- 24
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Diabetes, obesity & metabolism
- Publication Type :
- Academic Journal
- Accession number :
- 34514692
- Full Text :
- https://doi.org/10.1111/dom.14548