Assessment of the variability of glycemia, application of sitagliptin compared to placebo, in patients with diabetes type 2 diabetes with inadequate glycemic control on treatment with metformin

• Alexander S. Ametov
• Butaeva S.G.

Abstract

Aim. To evaluate glycemic variability during therapy sitagliptin 50 mg 2 times a day in combination with metformin 1000 mg two times a day compared to placebo in combination with metformin 1000 mg two times a day.

Material and methods. A randomized, double-blind, placebo-controlled study to assess the variability of blood glucose by continuous glucose monitoring (CGM). Results of CGM for 72 hours assessed at screening on metformin monotherapy, 2000 mg/day, and 3 weeks after treatment intensification sitagliptin (n=25) or placebo (n=23). Also assessed anthropometric parameters, carbohydrate metabolism, carried out the quality of life assessment on the SF-36 questionnaire.

Results. The study population in both groups the mean amplitude fluctuations in blood glucose levels (MAGE) and the standard deviation from the mean glucose level (STD) at the end of the study consistent with their initial values. However, in the group of sitagliptin/metformin positive dynamics was revealed secondary endpoint: the duration of periods of hyperglycemia has been halved compared to the screening stage: from 60.20 to 19.40% (p=0.000063). The duration of periods of normoglycemia was 79.36% at the end of therapy visit against 39.72% obtained at screening (p=0.000063). Also in the treatment group was registered a tendency to normalization of fasting plasma glucose (Visit Day 1 – 7.78 mmol/L: Visit Day 31 – 6.59 mmol/L; p=0.01) and postprandial glucose (visit Day 1 – 9.84 mmol/L; Day 31 visit – 7.86 mmol/L; p=0.01). After 3 weeks of therapy glycated hemoglobin concentration was 6.7% versus 7.91% at the start (p=0.000063). In placebo/metformin group significant changes in glycemic parameters structure, according CGM, fasting plasma levels and postprandial glucose were absent.

Conclusions. The addition of sitagliptin was not significantly affected by the change and MAGE and STD compared with the placebo group. However, account trends in improving glycemic profile structure: an increase in the period of normoglycemia, decrease hyperglycemiatime; without hypoglycemic state.

Keywords:type 2 diabetes mellitus, sitagliptin, variability of glycemia

All articles in our journal are distributed under the Creative Commons Attribution 4.0 International License (CC BY 4.0 license)