insulin--isophane and Birth-Weight

A randomized, open-label, parallel study was conducted to assess the efficacy and safety of premixed insulin aspart 30 (biphasic insulin aspart [BIAsp] 30) in managing gestational diabetes mellitus (GDM). A total of 323 women with GDM registered at a single center in India were randomly assigned to receive 6 U of either BIAsp 30 (Group A) or premixed human insulin (biphasic human insulin [BHI] 30; Group B) in a 1:1 ratio. Subjects performed home glucose monitoring and visited their care provider twice a month. The primary outcome was the degree of neonatal macrosomia (neonatal birth weight >90th percentile). Groups A and B were demographically comparable at study entry. Before labor onset, Groups A and B achieved similar degrees of fasting plasma glucose and postprandial plasma glucose control (92.97 ± 14.44 vs. 95.43 ± 18.96 and 127.59 ± 28.99 vs. 126.98 ± 29.89, respectively; both p = NS). Neonatal macrosomia frequency was 6.3% in Group A and 6.9% in Group B; however, this difference was not statistically significant. By last visit, the required insulin dose was significantly lower for Group A than Group B (19.83 ± 15.75 IU vs. 26.34 ± 23.15 IU, respectively; p = 0.006). BIAsp 30 was noninferior to BHI 30, producing comparable fetal outcomes when administered during pregnancy. Based on final doses, BIAsp 30 may offer greater treat-to-target potential for pregnant women.

Topics: Biphasic Insulins; Birth Weight; Blood Glucose; Cohort Studies; Diabetes, Gestational; Drug Combinations; Female; Fetal Macrosomia; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; India; Infant, Newborn; Insulin Aspart; Insulin, Isophane; Intention to Treat Analysis; Male; Pregnancy

To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM).. This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications.. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P<0.001). Two groups were comparable according to neonatal and obstetric complications (P>0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia.. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin.

Topics: Adult; Birth Weight; Blood Glucose; Diabetes, Gestational; Drug Therapy, Combination; Female; Fetal Macrosomia; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin, Isophane; Lost to Follow-Up; Metformin; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Single-Blind Method; Weight Gain

The objective of the study was to compare premixed insulin aspart 30 (BIAsp 30) vs premixed human insulin 30 (BHI 30) on efficacy, safety, fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [GDM]. This was the first randomized study to use pre mixed insulin analogue [BIAsp] in GDM.. The study population consisted of 76 GDM women assigned to BIAsp 30 (group A) and an equal number to BHI 30 (group B).. There was no statistically significant difference between the age, BMI, gestational weeks and glycemic level at entry between the group A and group B women (p > 0.05). There was no statistical difference between the two groups in glycemic control or insulin dose (p > 0.05) before confinement. The frequency of birth weight of new born above 90 percentile was 6.8% in Group 1 and 9.2% in Group 2. The proportion of macrosomia was higher in Group 2 when compared to Group 1, however the difference was not statistically significant (P = 0.819).. BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing. Fetal outcome using BIAsp was also comparable with BHI 30.

Topics: Adult; Biphasic Insulins; Birth Weight; Blood Glucose; Body Mass Index; Chromatography, High Pressure Liquid; Diabetes, Gestational; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Injections, Subcutaneous; Insulin; Insulin Aspart; Insulin, Isophane; Pilot Projects; Pregnancy; Pregnancy Outcome; Treatment Outcome; Young Adult

We compared maternal and neonatal outcomes in diabetic pregnancies treated with either insulin glargine or neutral protamine Hagedorn (NPH) insulin. We performed a retrospective chart review of diabetic pregnant patients using the Diabetes Care Center of Wake Forest University during the years 2000 to 2005. Outcomes of interest included maternal hemoglobin A1C, average fasting and 2-hour postprandial blood sugars, mode of delivery, birth weight, 5-minute Apgar score < 7, umbilical artery pH < 7.20, incidence of neonatal hypoglycemia, and pregnancy complications. A total of 52 diabetic pregnant patients were included in this study. Twenty-seven women used insulin glargine. A total of 13 women used insulin glargine during the first trimester. Glycemic control was similar in women who used NPH insulin and insulin glargine, as determined by hemoglobin A1C levels and mean blood sugar values. There were no differences in mode of delivery, average birth weight, or neonatal outcomes. Maternal and fetal/neonatal outcomes appear similar in pregnant diabetic women who use either NPH insulin or insulin glargine in combination with a short-acting insulin analogue to achieve adequate glycemic control during pregnancy. Insulin glargine appears to be an effective insulin analogue for use in women whose pregnancies are complicated by diabetes.

Topics: Adult; Apgar Score; Birth Weight; Blood Glucose; Carbon Dioxide; Delivery, Obstetric; Diabetes, Gestational; Eating; Fasting; Female; Gestational Age; Glycated Hemoglobin; Humans; Hydrogen-Ion Concentration; Hypoglycemia; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Oxygen; Pregnancy; Pregnancy Complications; Pregnancy in Diabetics; Pregnancy Outcome; Retrospective Studies; Umbilical Arteries; Young Adult

Permanent neonatal diabetes mellitus is a rare disorder known to be caused by activating mutations in KCNJ11 or ABCC8, inactivating mutations in INS, or very rarely in GCK or insulin promotor factor-1 (IPF-1) genes. We report a patient with permanent neonatal diabetes mellitus and severe exocrine pancreatic insufficiency. Ultrasound examination revealed pancreatic agenesis with a suggestion of a small amount of tissue in the head of the pancreas. Genetic testing revealed that the neonate had a homozygous Pro63fsX60 IPF-1 mutation. This is the second reported case of neonatal diabetes mellitus secondary to a homozygous mutation in the IPF-1 gene and supports the previously proposed biological role of IPF-1 in the pancreatic development in human.

Topics: Birth Weight; Blood Glucose; Body Height; Body Weight; Cesarean Section; Chromosomes, Human, Pair 6; Diabetes Mellitus; Diabetes, Gestational; Female; Homeodomain Proteins; Homozygote; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin, Isophane; Male; Mothers; Mutation; Pancreas; Pregnancy; Trans-Activators; Young Adult

Fifty insulin-dependent pregnant diabetic women were treated from presentation at the antenatal clinic with a regimen of either porcine or biosynthetic human soluble and isophane insulins. Blood glucose values, glycosylated haemoglobin, insulin requirements and outcome of pregnancy were compared in the two groups of patients. No difference was noted in blood glucose control, birth weight or neonatal complications. In the group treated with human insulin, fasting blood glucose could only be controlled by significantly greater doses of human isophane insulin injected before the evening meal. Furthermore, in two cases adequate glycaemic control required the injection of the evening human isophane insulin to be delayed until bedtime.

Topics: Adult; Animals; Birth Weight; Blood Glucose; Female; Humans; Infant, Newborn; Insulin; Insulin, Isophane; Pregnancy; Pregnancy in Diabetics; Swine