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Saxagliptin co‐therapy in C‐peptide negative Type 1 diabetes does not improve counter‐regulatory responses to hypoglycaemia
Author(s) -
George P. S.,
McCrimmon R. J.
Publication year - 2016
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/dme.13046
Subject(s) - saxagliptin , medicine , type 2 diabetes , crossover study , placebo , incretin , diabetes mellitus , hypoglycemia , area under the curve , randomized controlled trial , blood sugar regulation , dipeptidyl peptidase 4 inhibitor , endocrinology , alternative medicine , pathology , sitagliptin
Aims To test the hypothesis that dipeptidyl peptidase‐4 inhibition in C‐peptide negative Type 1 diabetes would reduce glucose variability and exposure to hypoglycaemia and therefore may indirectly enhance counter‐regulatory responses to subsequent hypoglycaemia. Methods We conducted a 12‐week double‐blind, randomized, placebo‐controlled crossover study. The study was conducted in a tertiary hospital outpatient clinic, with additional studies performed in a clinical research centre. After obtaining informed consent, we recruited 14 subjects with moderately well controlled Type 1 diabetes (HbA 1c 64 ± 2 mmol/mol) of long duration (20.5 ± 2.7 years). The subjects received 12 weeks' therapy with oral saxagliptin (5 mg) or placebo. Glucose variability, assessed via continuous glucose monitoring, together with frequency of hypoglycaemia, hypoglycaemia awareness and symptomatic, cognitive and counter‐regulatory hormone responses to experimental hypoglycaemia, were assessed. Additional outcome measures included HbA 1c level, weight, total daily insulin dose and adverse events. Results Saxagliptin co‐therapy did not reduce glucose variability (low blood glucose index, average daily risk range), hypoglycaemia frequency or awareness and did not improve counter‐regulatory hormonal responses during experimental hypoglycaemia (area under the curve for adrenaline 25 775 vs. 24 454, for placebo vs saxagliptin, respectively; P = 0.76). Conclusions No additional benefit of dipeptidyl peptidase‐4 inhibition co‐therapy with saxagliptin in the management of Type 1 diabetes was observed.