insulin-detemir and Diabetes--Gestational

Diabetes during pregnancy causes both fetal and maternal complications. Insulin is the most effective pharmacological treatment for controlling hyperglycemia during gestation and can limit adverse outcomes. Insulin detemir (IDet), a novel basal insulin, has already been used for this indication for several years. It was reclassified in 2012 by the FDA from category C to category B for the treatment of pregnant women with diabetes.. This article reviews published data regarding the use of IDet during pregnancy. We discuss pharmacokinetic and pharmacodynamic qualities of IDet and potential advantages for its use during pregnancy.. IDet is a viable option for the management of diabetes during pregnancy. Though data is limited, its safety and efficacy is probably comparable to human insulin, and in some aspects superior to it. More data, specifically for IDet in pregnancies complicated by gestational diabetes (GDM) or type 2 diabetes, is needed.

Topics: Animals; Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Pregnancy

The objective of this study was to assess the safety of four insulin analogs (aspart, lispro, glargine, and detemir) for the treatment of diabetes in pregnancy.. We searched Embase, Pubmed, and the Cochrane Central Register for Controlled Trials database through May 31, 2014. All articles were reviewed by two independent researchers, and if a discrepancy was noted, a third researcher was consulted. Results data were summarized by RevMan 5.2 software.. Our search resulted in the retrieval and screening of 3519 studies. Of those, 24 studies met the eligibility criteria; the studies reported on a total of 3734 women with pre-gestational or gestational diabetes during pregnancy. The use of lispro was associated with lower rates of neonatal jaundice (RR = 0.63) and severe maternal hypoglycemia (RR = 0.33) than regular insulin. Lispro use was also associated with higher birth weight (WMD = 116.44) and an increased incidence of large for gestational age (LGA) births (RR = 1.42) compared with regular insulin. Rates of cesarean section and macrosomia were similar in pregnant women treated with aspart and regular insulin. Birth weights and rates of severe maternal hypoglycemia, respiratory dysfunction syndrome, and neonatal intensive care unit admission were similar after pregnant women were treated with glargine and NPH insulin. Rates of LGA, macrosomia, and neonatal hypoglycemia were similar after pregnant women were treated with detemir and NPH insulin.. Aspart, glargine, and detemir are safe treatment options for diabetes during pregnancy; these insulin analogs did not increase complications for the mothers or fetuses in our study. However, lispro was related to higher birth weight and increased rate of LGA in neonates. More high-quality randomized controlled trials are needed to clarify the best treatment options for diabetes during pregnancy.

Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Infant, Newborn, Diseases; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome

Excellent glycaemic control is essential in pregnancy to optimise maternal and foetal outcomes. The aim of this review is to assess the efficacy and safety of insulin analogues in pregnancy. Insulin lispro and insulin aspart are safe in pregnancy and may improve post-prandial glycaemic control in women with type 1 diabetes. However, a lack of data indicating improved foetal outcomes would suggest that there is no imperative to switch to a short-acting analogue where the woman's diabetes is well controlled with human insulin. There are no reports of the use of insulin glulisine in pregnancy and so its use cannot be recommended. Most studies of insulin glargine in pregnancy are small, retrospective and include women with pre-existing diabetes and gestational diabetes. There appear to be no major safety concerns and so it seems reasonable to continue insulin glargine if required to achieve excellent glycaemic control. A head-to-head comparison between insulin detemir and NPH insulin in women with type 1 diabetes showed that while foetal outcomes did not differ, fasting plasma glucose improved with insulin detemir without an increased incidence of hypoglycaemia. The greater evidence base supports the use of insulin detemir as the first line long-acting analogue in pregnancy but the lack of definitive foetal benefits means that there is no strong need to switch a woman who is well controlled on NPH insulin. There seems little justification in using long acting insulin analogues in women with gestational diabetes or type 2 diabetes where the risk of hypoglycaemia is low.

Topics: Blood Glucose; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Dose-Response Relationship, Drug; Female; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Detemir; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Randomized Controlled Trials as Topic; Treatment Outcome

It is well known that good metabolic control maintained throughout pregnancy reduces maternal and fetal complications in diabetes. Before conception and throughout pregnancy, insulin therapy needs to be optimized and, in this context, the insulin analogs currently available in the market may help to achieve good metabolic control. We therefore review here what is known about the potential benefits and risks related to the use of these new insulins in pregnancy. Clinical and experimental data on insulin aspart and lispro strongly suggest that they have no adverse maternal or fetal effects during pregnancy in women with pregestational and gestational diabetes, and that their use results in improved glycemic control, fewer hypoglycemic episodes, and improved patient satisfaction. At present there are no published data on the use of glulisine in pregnancy. Insulin glargine during pregnancy is not recommended but, in the last years, larger surveys (retrospective and case-control studies) have been published on this field and, to date, results of about 335 pregnancies with type 1 diabetes are available showing an incidence of congenital malformation similar to that obtained with human insulin. There are no published data concerning the use of detemir in pregnancy but the results of a prospective study are expected in 2010.

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy

This review reports the literature on the safety and efficacy of insulin analogues in pregnancy and thereby enables the clinician to choose the optimal insulin treatment protocol to achieve and maintain normoglycemia throughout pregnancies complicated by diabetes. This article also reviews the literature on the insulin analog during pregnancy and presents the authors' opinion as to the safety and efficacy of insulin analog treatment for the pregnant diabetic woman.

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Receptor, IGF Type 1

Gestational diabetes mellitus (GDM) is one of the prevalent adverse conditions among pregnant women which needs delicate monitoring and control. GDM is a state in which the pregnant women's blood glucose level exceeds the normal range. Our goal was to determine the best therapeutic method to control the blood glucose level among GDM patients by comparing of the efficacy between two Insulin consisting, Novo-rapid + Levemir Insulin and Regular + NPH Insulin.. In this double-blind, randomized clinical trial study, we enrolled 100 women with GDM as an inpatient. In group A, patients underwent treating with Regular + NPH Insulin, and in group B, patients underwent treating with Novo-rapid + Levemir Insulin. Patient's demographic and clinical information gathered by specified several times during the study and analysis performed by SPSS21.. Despite significant changes in the two groups patient's blood glucose levels; we could not find any remarkable differences between the two groups. In the case of patient and health care system satisfaction and the length of the hospitalization group, B was better than group A.. Altogether, The Novo-rapid and Levemir Insulin in comparing with the Regular and NPH Insulin were practically advantageous due to the simple using method and short hospitalization period of the patient. Thus, we prefer and suggest this beneficial method (using Novo-rapid and Levemir Insulin) to reach therapeutic goals.

Topics: Adult; Blood Glucose; Diabetes, Gestational; Double-Blind Method; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Pregnancy; Young Adult

We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy.. We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed.. In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group.. IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.

Topics: Adolescent; Adult; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Administration Schedule; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Intention to Treat Analysis; Pregnancy; Pregnancy in Diabetics; Treatment Outcome; Young Adult

Treatment of gestational diabetes mellitus (GDM) has been shown to improve both maternal and neonatal outcomes. For women with GDM who require glucose-lowering medication, insulin is regarded as the drug of choice by most medical societies. Oral therapy, with metformin or glibenclamide, is a reasonable alternative in certain medical circumstances.. To compare the efficacy and safety of insulin detemir (IDet) vs. glibenclamide for GDM when glycemic control cannot be achieved through lifestyle modification and diet.. We conducted a retrospective cohort analysis of 115 women with singleton pregnancy and GDM treated with IDet or glibenclamide. GDM was diagnosed via the two-step oral glucose tolerance test (OGTT) of 50 grams glucose, followed by 100 grams. Maternal characteristics and outcomes (preeclampsia and weight gain) and neonatal outcomes (birth weight and percentile, hypoglycemia, jaundice, and respiratory morbidity) were compared between groups.. In total, 67 women received IDet and 48 glibenclamide. Maternal characteristics, weight gain, and the incidence of preeclampsia were similar in both groups. Neonatal outcomes were also similar. The proportion of large for gestational age (LGA) infants was 20.8% in the glibenclamide group compared to 14.9% in the IDet group (P = 0.04).. In pregnant women with GDM, glucose control on IDet yielded comparable results as on glibenclamide, except for a significantly lower rate of LGA neonates.

Topics: Birth Weight; Diabetes, Gestational; Female; Glucose; Glyburide; Humans; Infant; Infant, Newborn; Insulin Detemir; Pre-Eclampsia; Pregnancy; Retrospective Studies

The objective of this retrospective study was to compare glycemic control, pregnancy outcomes, and neonatal outcomes in women with gestational diabetes mellitus (GDM) treated with (a) insulin detemir and (b) insulin neutral protamine Hagedorn (NPH).. A total of 192 women with GDM were included in the analysis. Ninety-eight women received detemir, while 94 women received NPH. Data regarding medical history, glycemic control, and time and mode of delivery, as well as neonatal outcomes, were recorded.. Baseline characteristics were comparable between the two groups. There were no differences with respect to the week of insulin initiation, total insulin dose, duration of insulin therapy, daily insulin dose/weight in early and late pregnancy, or the number of insulin injections per day. Maternal overall weight gain during pregnancy and weight gain per week did not differ either. The detemir group had slightly lower HbA1c levels at the end of gestation [median: det 5.2% (33 mmol/mol) vs NPH 5.4% (36 mmol/mol), p=0.035). There were no cases of hypoglycemia or allergic reactions in the two groups. There were also no differences regarding neonatal outcomes according to the available data, given that data in some cases were missing.. The use of insulin detemir was found to be equally effective and safe compared to NPH in women with GDM.

Topics: Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Glycemic Control; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy Outcome; Retrospective Studies; Weight Gain

To evaluate the effectiveness of the different insulin therapies on obstetrics-fetal outcomes in women with pregestational diabetes mellitus. We enrolled 147 pregnant women with pre-existing type 1 or 2 diabetes mellitus. Clinical and biochemical parameters were analysed in relation to obstetric and fetal outcomes. 14.2% received treatment with Neutral Protamine Hagedorn insulin and short-acting insulin analogues; 19% with premixed human insulin; 40.1% with insulin glargine and lispro, 6.2% with detemir and aspart and 20% with continuous subcutaneous insulin infusion. All 5 types of treatment achieved a reduction of the mean HbA1c during pregnancy (p = 0.01). Pre-pregnancy care was carried out for 48% of patients. We found no statistically significant differences between the different insulin therapies and the obstetric-fetal outcomes. In conclusión, the different insulin therapies used in patients with pregestational diabetes mellitus does not seem to affect obstetric-fetal outcomes.

Topics: Adult; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Combinations; Female; Glycated Hemoglobin; Humans; Insulin; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy; Pregnancy Outcome

Gestational diabetes mellitus (GDM) occurs in 2-9% of all pregnancies. Evidence suggests that the use of insulin in treating hyperglycemia in GDM patients reduces the risk of perinatal morbidity. Pregnancy is an exciting time in a woman's life. However, once patient is diagnosed with GDM, she will be managed more intensively. GDM is managed using diet and exercise but one in six women with GDM requires insulin. A 35-year-old woman at the 14th gestational week of her tenth pregnancy was seen for routine prenatal care. She had the history of nine consecutive spontaneous abortions. Patient was hospitalized and based on the revealed glucose values insulin therapy was initiated with long-acting insulin analogue - Levemir and rapid-acting insulin analogue - NovoRapid. Patient's diabetes was compensated on insulin therapy. Follow-ups were planned at intervals of 1-2 weeks depending on the glucose levels. This is the case report of a GDM in a high-risk patient. She's at the 21st gestational weeks and has passed "delicate weeks". At her 21st week of gestation patient's glucose levels are compensated on insulin therapy and she is feeling well. In this unusual case report, no insulin therapy had been started during previous pregnancies, so we managed to achieve a good glycemic control with insulin treatment. This could be one of the factors that could help a normal pregnancy and delivery. The discussion should be focusing on early screening and proper treatment for GDM.

Topics: Abortion, Spontaneous; Adult; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Therapy, Combination; Female; Humans; Hypoglycemic Agents; Insulin Aspart; Insulin Detemir; Mutation; Pregnancy; Risk Factors

To evaluate the safety, efficacy and pregnancy outcomes of insulin detemir (IDet) versus glyburide treatment in women with gestational diabetes mellitus (GDM).. We conducted a retrospective cohort study of women with GDM who were treated with either glyburide or IDet for GDM in a university-affiliated tertiary hospital.. Ninety-one patients with GDM were enrolled, 62 were administered glyburide and 29 IDet. Maternal age, pregestational body mass index (BMI) and rate of abnormal oral glucose tolerance test (OGTT) blood glucose values were not significantly different between groups. Good glycemic control rates were comparable. Hypoglycemic episodes were reported only in the glyburide group (19.4% versus 0%, p = 0.01). Maternal weight gain during pregnancy was significantly higher among women in the glyburide group (8.8 ± 5.1 kg, p < 0.001) compared to those in the IDet group (2.1 ± 19.9 kg, p = 0.71).. To the best of our knowledge, this is the first study on IDet treatment in patients with GDM. By our preliminary results, IDet is a viable treatment option in women with GDM. Further large prospective studies are needed to determine the efficacy and safety of IDet in GDM patients.

Topics: Adult; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemic Agents; Insulin Detemir; Outcome Assessment, Health Care; Pregnancy; Pregnancy Outcome; Retrospective Studies

Topics: Adult; Diabetes, Gestational; Disease Management; Female; Humans; Hypersensitivity; Insulin Detemir; Pregnancy

Topics: Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Insulin, Long-Acting; Placenta; Pregnancy; Pregnancy in Diabetics