Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study

Abstract

ObjectiveTo compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin used in pregnant women with diabetes.Research design and methodsA randomized study was conducted in diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes). All patients were randomly divided into two groups: IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR–IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR–NPH plan). Patients were enrolled during 12–28 gestation weeks and followed up until delivery.ResultsBasal characteristics, such as age, enrollment gestational weeks, average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT) were similar between two groups. After 1 week of treatment, the FPG of IDet group were significantly lower than NPH group (p<0.05) and the time required to reach the targeted blood glucose level was significantly shorter (p<0.001). After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level. Maternal and neonatal outcomes were comparable between the two therapeutic approaches; however, the incidence of hypoglycemia in IDet group was remarkably lower than that of NPH group (p<0.05). The adverse drug reactions were rare and similar between the two groups.ConclusionsFor the treatment of gestational diabetes, both RRR–IDet plan and RRR–NPH plan were reported to control blood glucose effectively. Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes. Therefore, for pregnant women with gestational diabetes, who require insulin therapy, IDet would be an ideal basal insulin being worthy of promotion in clinical settings.

The association of energy and macronutrient intake at dinner vs breakfast with the incidence of type 2 diabetes mellitus in a cohort study: The China Health and Nutrition Survey, 1997‐2011

“…The prevalence of gout is increasing and can be exacerbated due to T2DM as well 43 . We are going to investigate the relationship between breakfast and dinner energy or macronutrient intake and the risk of T2DM in people with gout and other vulnerable groups including pregnant women 4 …”

“…An epidemiological survey confirmed that China had the largest number of T2DM patients and the prevalence of T2DM in China had reached 10.9% 3 . The prevalence of gestational diabetes and prepregnancy diabetes mellitus is increasing year by year, especially for gestational diabetes 4 . A scientific and appropriate diet, as an important modifiable behavior, plays a critical role in the prevention and management of T2DM 5,6 .…”

Single site pilot clinical investigation of a novel app-assisted self-management programme for gestational diabetes

“…Insulin determir demonstrates non-inferiority to NPH in achieving glycaemic control for patients with GDM and Type 2 Diabetes Mellitus and reaches this goal with fewer episodes of hypoglycaemia [106]. Insulin determir has also been found to reach glycaemic targets quicker than NPH thus necessitating fewer daily injections, an important patient acceptability metric [107]. Short acting insulin analogs formulated through amino acid substitution on the beta chain, include insulin lispro and aspart.…”

Insulin therapy in diabetic kidney disease

“…An Endocrine Society Clinical Practice Guideline recommends that diabetic women who receive insulin therapy and want to conceive should be treated with insulin lispro or insulin aspart instead of regular insulin, and those who successfully used long-acting insulin analogs before pregnancy can continue to use this treatment during pregnancy [144]. Studies have shown that the use of insulin detemir can improve fasting blood glucose levels and reduce the incidence of hypoglycemia without increasing the incidence of adverse pregnancy and drug reactions in pregnant women with diabetes [145][146][147][148][149]. A randomized controlled study reported no nocturnal hypoglycemia in the detemir group, and hypoglycemia occurred before lunch; however in the NPH group, hypoglycemia was irregular, and nocturnal hypoglycemia threatened the safety of the fetus [147].…”

“…Studies have shown that the use of insulin detemir can improve fasting blood glucose levels and reduce the incidence of hypoglycemia without increasing the incidence of adverse pregnancy and drug reactions in pregnant women with diabetes [145][146][147][148][149]. A randomized controlled study reported no nocturnal hypoglycemia in the detemir group, and hypoglycemia occurred before lunch; however in the NPH group, hypoglycemia was irregular, and nocturnal hypoglycemia threatened the safety of the fetus [147].…”