Phase 4 Humalog® Mix50/50(tm) for the Treatment of Insulin Requiring Gestational Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in terms of glucose control for women with Gestational Diabetes.
详细描述
Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes.
Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over combination rapid-acting plus NPH insulin because it involves fewer injections, and those injections are associated with mealtime. The potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and at least 13 weeks gestation
- •Diagnosed with gestational diabetes mellitus
- •Failed diet therapy
排除标准
- •<18 years old or over 45 years old
- •urine dipstick >2+ protein
- •blood pressure >140/80 mmHg
- •hematocrit <30%
- •refusal to take insulin
- •inability to understand instructions or to consent to participate.
研究组 & 干预措施
Mix 50/50
Insulin LISPRO: 3 doses of Humalog® Mix50/50™ at mealtime.
干预措施: Insulin LISPRO (Drug)
Usual insulin regimen
Usual insulin regimen of insulin, Long-Acting and Insulin: 3 injections of Humalog(r) daily with meals; 3 injections of Humulin N (r) daily on rising, mid-afternoon, and at bedtime
干预措施: Insulin, Long-Acting and Insulin (Drug)
结局指标
主要结局
Hemoglobin A1C
时间窗: During Pregnancy (at approximately 28 weeks gestation)
Compare the efficacy and safety of three daily injections of Humalog® Mix50/50TM to six daily injections of Humalog® and Humulin N® insulin, by hemoglobin A1C.
次要结局
- Birthweight of Infant(End of pregnancy)
研究者
Kristin Castorino, DO
Research Physician
Sansum Diabetes Research Institute