Endocrine Abstracts

Diabetes is endemic in society. Beyond lifestyle modification (often short lived) and metformin, which while effective has gastrointestinal side effects, other available pharmacological options are challenging to implement across populations of newly diagnosed patients. The recent position statement by ADA/EASD calls for patient-centred individualised therapies to suit patients’ need. Glucose-lowering nutritional supplements may be an effective and safe option for newly diagnosed hyperglycaemia. But, their safety and efficacy have not been systematically evaluated in randomized clinical trials. In this 12-week, investigator-initiated, six-centre, randomized, double-blind, placebo-controlled, phase 3 trial, newly diagnosed subjects (n=232) with FPG >100 mg/dl received PreCrea (a proprietary nutritional supplement containing standardized plant extracts and dietary elements) or placebo one capsule twice daily along with lifestyle modification. Primary endpoint was the change from baseline HbA1c at week 12. Secondary endpoint was change from baseline in FPG. At week 12, HbA1c was significantly reduced from baseline with PreCrea compared to placebo (−0.91 vs +0.08%); P<0.001). Reductions in FPG in the PreCrea group compared to placebo (P 0.0428) (−23.1 mg/dl vs −7.2 mg/dl at week 12), with no hypoglycaemia, no weight gain and no adverse effects and no difference in safety parameters. PreCrea provided clinically important and statistically significant improvements in glycaemic control compared to placebo. The efficacy (nearly 1% reduction in HbA1c), safety and tolerability profile of PreCrea highlights its potential as an initial therapy choice in newly diagnosed hyperglycaemia and in patients intolerant or reluctant to take metformin. Longer head-to-head comparative studies would be required to evaluate efficacy with PreCrea over other oral hypoglycaemia agents in such patients. (ClinicalTrials.gov: NCT02189005; www.essens-study.com).

Disclosure: From PreEmptive Meds, Inc. and Abbott Laboratories.