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Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.

ABSTRACT: OBJECTIVE:To evaluate effects of the dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS:Data sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) double-blind randomized trials evaluating sotagliflozin versus placebo in adults with type 1 diabetes treated with optimized insulin were pooled for analyses of masked CGM data from a subset of participants in each trial. The pooled cohort included patients randomized to receive placebo (n = 93), sotagliflozin 200 mg (n = 89), or sotagliflozin 400 mg (n = 96). The primary outcome was change from baseline to week 24 in glucose TIR (3.9-10.0 mmol/L [70-180 mg/dL]). Secondary end points included time below and above the target range and 2-h PPG level assessed after a standardized mixed meal. RESULTS:Mean percentage of glucose TIR/percentage time spent at <3.9 mmol/L (<70 mg/dL) during week 24 was 51.6%/5.9%, 57.8%/5.5%, and 64.2%/5.5% with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively, which corresponded to a placebo-adjusted change from a baseline of +5.4%/-0.3% (P = 0.026; +1.3/-0.1 h/day) for sotagliflozin 200 mg and +11.7%/-0.1% (P < 0.001; +2.8/-0.02 h/day) for sotagliflozin 400 mg. Placebo-adjusted PPG reductions were 1.9 ± 0.7 mmol/L (35 ± 13 mg/dL; P = 0.004) and 2.8 ± 0.7 mmol/L (50 ± 13 mg/dL; P < 0.001) with sotagliflozin 200 and 400 mg, respectively. CONCLUSIONS:Combined with optimized insulin in type 1 diabetes, sotagliflozin significantly increased glucose TIR without increasing time spent at <3.9 mmol/L and reduced PPG, thereby improving glycemic control.

SUBMITTER: Danne T

PROVIDER: S-EPMC6905498 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.

Danne Thomas T Cariou Bertrand B Buse John B JB Garg Satish K SK Rosenstock Julio J Banks Phillip P Kushner Jake A JA McGuire Darren K DK Peters Anne L AL Sawhney Sangeeta S Strumph Paul P

Diabetes care 20190304 5

<h4>Objective</h4>To evaluate effects of the dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor sotagliflozin in combination with insulin on glucose time in range (TIR) and glucose excursions, postprandial glucose (PPG), and other glycemic metrics in adults with type 1 diabetes using masked continuous glucose monitoring (CGM).<h4>Research design and methods</h4>Data sets from the inTandem1 (clinical trial reg. no. NCT02384941) and inTandem2 (clinical trial reg. no. NCT02421510) doubl ...[more]

PMID: 30833371

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Project description:A reduction in carbohydrate intake and low-carbohydrate diets are often advocated to prevent and manage diabetes. However, limiting or eliminating carbohydrates may not be a long-term sustainable and maintainable approach for everyone. Alternatively, diet strategies to modulate glycemia can focus on the glycemic index (GI) of foods and glycemic load (GL) of meals. To assess the effect of a reduction in glycemic load of a 24 h diet by incorporating innovative functional ingredients (β-glucan, isomaltulose) and alternative low GI Asian staples (noodles, rice)on glycemic control and variability, twelve Chinese men (Age: 27.0 ± 5.1 years; BMI:21.6 ± 1.8kg/m2) followed two isocaloric, typically Asian, 24h diets with either a reduced glycemic load (LGL) or high glycemic load (HGL) in a randomized, single-blind, controlled, cross-over design. Test meals included breakfast, lunch, snack and dinner and the daily GL was reduced by 37% in the LGL diet. Continuous glucose monitoring provided 24 h glycemic excursion and variability parameters: incremental area under the curve (iAUC), max glucose concentration (Max), max glucose range, glucose standard deviation (SD), and mean amplitude of glycemic excursion (MAGE), time in range (TIR). Over 24h, the LGL diet resulted in a decrease in glucose Max (8.12 vs. 6.90 mmol/L; p = 0.0024), glucose range (3.78 vs. 2.21 mmol/L; p = 0.0005), glucose SD (0.78 vs. 0.43 mmol/L; p = 0.0002), mean amplitude of glycemic excursion (2.109 vs. 1.008; p < 0.0001), and increase in 4.5-6.5mmol/L TIR (82.2 vs. 94.6%; p = 0.009), compared to the HGL diet. The glucose iAUC, MAX, range and SD improved during the 2 h post-prandial window of each LGL meal, and this effect was more pronounced later in the day. The current results validate the dietary strategy of incorporating innovative functional ingredients (β-glucan, isomaltulose) and replacing Asian staples with alternative low GI carbohydrate sources to reduce daily glycemic load to improve glycemic control and variability as a viable alternative to the reduction in carbohydrate intake alone. These observations provide substantial public health support to encourage the consumption of staples of low GI/GL to reduce glucose levels and glycemic variability. Furthermore, there is growing evidence that the role of chrononutrition, as reported in this paper, requires further examination and should be considered as an important addition to the understanding of glucose homeostasis variation throughout the day.

Dataset Information

Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.

Publications

Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program.

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