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Diabetes Care. 2015 Jul;38(7):1181-8. doi: 10.2337/dc14-2806. Epub 2015 Jun 6.

Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, as Adjunct Therapy to Insulin in Type 1 Diabetes.

Author information

1
Lexicon Pharmaceuticals, Inc., The Woodlands, TX arthur.sands@bcm.edu pstrumph@lexpharma.com.
2
Lexicon Pharmaceuticals, Inc., The Woodlands, TX.
3
Dallas Diabetes and Endocrine Center, Dallas, TX.
4
Atlanta Diabetes Associates, Atlanta, GA.
5
University of Colorado Denver/Barbara Davis Center for Childhood Diabetes, Aurora, CO.
6
University of North Carolina School of Medicine, Chapel Hill, NC.
7
Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY.
8
Creighton Diabetes Center, Omaha, NE.
9
Pennington Biomedical Research Center, Baton Rouge, LA.

Abstract

OBJECTIVE:

To assess the safety and efficacy of dual sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibition with sotagliflozin as adjunct therapy to insulin in type 1 diabetes.

RESEARCH DESIGN AND METHODS:

We treated 33 patients with sotagliflozin, an oral dual SGLT1 and SGLT2 inhibitor, or placebo in a randomized, double-blind trial assessing safety, insulin dose, glycemic control, and other metabolic parameters over 29 days of treatment.

RESULTS:

In the sotagliflozin-treated group, the percent reduction from baseline in the primary end point of bolus insulin dose was 32.1% (P = 0.007), accompanied by lower mean daily glucose measured by continuous glucose monitoring (CGM) of 148.8 mg/dL (8.3 mmol/L) (P = 0.010) and a reduction of 0.55% (5.9 mmol/mol) (P = 0.002) in HbA1c compared with the placebo group that showed 6.4% reduction in bolus insulin dose, a mean daily glucose of 170.3 mg/dL (9.5 mmol/L), and a decrease of 0.06% (0.65 mmol/mol) in HbA1c. The percentage of time in target glucose range 70-180 mg/dL (3.9-10.0 mmol/L) increased from baseline with sotagliflozin compared with placebo, to 68.2% vs. 54.0% (P = 0.003), while the percentage of time in hyperglycemic range >180 mg/dL (10.0 mmol/L) decreased from baseline, to 25.0% vs. 40.2% (P = 0.002), for sotagliflozin and placebo, respectively. Body weight decreased (1.7 kg) with sotagliflozin compared with a 0.5 kg gain (P = 0.005) in the placebo group.

CONCLUSIONS:

As adjunct to insulin, dual SGLT1 and SGLT2 inhibition with sotagliflozin improved glycemic control and the CGM profile with bolus insulin dose reduction, weight loss, and no increased hypoglycemia in type 1 diabetes.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01742208.

PMID:
26049551
PMCID:
PMC4831906
DOI:
10.2337/dc14-2806
[Indexed for MEDLINE]
Free PMC Article

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