Chantal Mathieu1, Paresh Dandona2, Moshe Phillip3,4, Tal Oron3,4, Marcus Lind5,6, Lars Hansen7, Fredrik Thorén8, John Xu9, Anna Maria Langkilde8. 1. Department of Endocrinology, UZ Gasthuisberg, KU Leuven, Leuven, Belgium chantal.mathieu@uzleuven.be. 2. Department of Medicine, University at Buffalo, The State University of New York, Buffalo, NY. 3. Jesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. 4. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 5. Institute of Medicine, University of Gothenburg, Gothenburg, Sweden. 6. Department of Medicine, NU Hospital Group, Uddevalla, Sweden. 7. MedImmune, Gaithersburg, MD. 8. AstraZeneca, Mölndal, Sweden. 9. AstraZeneca, Gaithersburg, MD.
Abstract
OBJECTIVE: This pooled analysis assessed continuous glucose monitoring (CGM) in patients with inadequately controlled type 1 diabetes (HbA1c ≥7.7 to ≤11.0% [≥61 to ≤97 mmol/mol]) who receiveddapagliflozin as an adjunct to adjustable insulin. RESEARCH DESIGN AND METHODS: CGM data were pooled from two 24-week, double-blind, randomized, phase 3 studies: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT-1 and DEPICT-2). These studies comprised 1,591 patients receivingdapagliflozin 5 mg (n = 530), dapagliflozin 10 mg (n = 529), or placebo (n = 532). RESULTS: Baseline characteristics were balanced between treatment groups. Patients receiving dapagliflozin 5 mg or 10 mg both spent more time with blood glucose in the range >3.9 to ≤10.0 mmol/L (>70 to ≤180 mg/dL) over 24 h than those receiving the placebo. The adjusted mean (SE) change from baseline at week 24 was 6.48% (0.60) with dapagliflozin 5 mg, 8.08% (0.60) with dapagliflozin 10 mg, and -2.59% (0.61) with placebo. At week 24, the mean amplitude of glucose excursion over 24 h, mean 24-h glucose values, and postprandial glucose values were also improved in patients receiving dapagliflozin over those receiving placebo. No marked differences were found at week 24 between dapagliflozin 5 or 10 mg and placebo in the percentage of glucose values ≤3.9 mmol/L (≤70 mg/dL) or ≤3.0 mmol/L (≤54 mg/dL) over 24 h, or in nocturnal (0000-0559 h) glucose values ≤3.9 mmol/L (≤70 mg/dL). CONCLUSIONS: In patients with type 1 diabetes, treatment with dapagliflozin over 24 weeks improved time in range, mean glucose, and glycemic variability without increasing the time spent in the range indicating hypoglycemia.
RCT Entities:
OBJECTIVE: This pooled analysis assessed continuous glucose monitoring (CGM) in patients with inadequately controlled type 1 diabetes (HbA1c ≥7.7 to ≤11.0% [≥61 to ≤97 mmol/mol]) who received dapagliflozin as an adjunct to adjustable insulin. RESEARCH DESIGN AND METHODS: CGM data were pooled from two 24-week, double-blind, randomized, phase 3 studies: Dapagliflozin Evaluation in Patients with Inadequately Controlled Type 1 Diabetes (DEPICT-1 and DEPICT-2). These studies comprised 1,591 patients receiving dapagliflozin 5 mg (n = 530), dapagliflozin 10 mg (n = 529), or placebo (n = 532). RESULTS: Baseline characteristics were balanced between treatment groups. Patients receiving dapagliflozin 5 mg or 10 mg both spent more time with blood glucose in the range >3.9 to ≤10.0 mmol/L (>70 to ≤180 mg/dL) over 24 h than those receiving the placebo. The adjusted mean (SE) change from baseline at week 24 was 6.48% (0.60) with dapagliflozin 5 mg, 8.08% (0.60) with dapagliflozin 10 mg, and -2.59% (0.61) with placebo. At week 24, the mean amplitude of glucose excursion over 24 h, mean 24-h glucose values, and postprandial glucose values were also improved in patients receiving dapagliflozin over those receiving placebo. No marked differences were found at week 24 between dapagliflozin 5 or 10 mg and placebo in the percentage of glucose values ≤3.9 mmol/L (≤70 mg/dL) or ≤3.0 mmol/L (≤54 mg/dL) over 24 h, or in nocturnal (0000-0559 h) glucose values ≤3.9 mmol/L (≤70 mg/dL). CONCLUSIONS: In patients with type 1 diabetes, treatment with dapagliflozin over 24 weeks improved time in range, mean glucose, and glycemic variability without increasing the time spent in the range indicating hypoglycemia.
Authors: Tadej Battelino; Thomas Danne; Richard M Bergenstal; Stephanie A Amiel; Roy Beck; Torben Biester; Emanuele Bosi; Bruce A Buckingham; William T Cefalu; Kelly L Close; Claudio Cobelli; Eyal Dassau; J Hans DeVries; Kim C Donaghue; Klemen Dovc; Francis J Doyle; Satish Garg; George Grunberger; Simon Heller; Lutz Heinemann; Irl B Hirsch; Roman Hovorka; Weiping Jia; Olga Kordonouri; Boris Kovatchev; Aaron Kowalski; Lori Laffel; Brian Levine; Alexander Mayorov; Chantal Mathieu; Helen R Murphy; Revital Nimri; Kirsten Nørgaard; Christopher G Parkin; Eric Renard; David Rodbard; Banshi Saboo; Desmond Schatz; Keaton Stoner; Tatsuiko Urakami; Stuart A Weinzimer; Moshe Phillip Journal: Diabetes Care Date: 2019-06-08 Impact factor: 19.112