A Trial Comparing the Effect and Safety of Insulin Degludec Versus Insulin Detemir, Both in Combination With Insulin Aspart, in the Treatment of Pregnant Women With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
研究概览
简要总结
The investigators are doing this study to see the effect of insulin degludec in pregnant women with type 1 diabetes, and if it is safe to use. In this study the medicine insulin degludec is compared to another medicine called insulin detemir. Participants will either get insulin degludec or insulin detemir and take it together with a medicine called insulin aspart - which treatment participants get is decided by chance. Participants will get pre-filled insulin pens. Participants will need to take blood sugar measurements several times a day. The study will last between 10 and 25 months depending on whether participants are already pregnant when they join the study. The number of visits and the tests ( for example blood and urine samples and ultrasound scans) the participants will have also depends on whether they are pregnant at study start.
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
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, age at least 18 years at the time of signing informed consent - Diagnosed with type 1 diabetes mellitus for at least 1 year prior to the day of screening - Treated with multiple daily subcutaneous insulin injections or continuous subcutaneous insulin infusion (CSII) or inhaled insulin for at least 90 days prior to the day of screening - The subject is planning to become pregnant within 12 months from randomisation and willing to undertake pre-pregnancy counselling or the subject is pregnant with an intrauterine singleton living foetus (gestational week 8 to 13 (+6 days)) without any observed anomalies at randomisation, confirmed by an ultrasound scan - HbA1c at screening below or equal to 8.0% (64 mmol/mol) by central laboratory
排除标准
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening - Pregnant and having proteinuria as evaluated by urine protein-to-creatinine ratio above or equal to 300 mg/g in urine sample measured at screening - Subject being treated or became pregnant with assistance of in vitro fertilisation or other medical infertility treatment - Receipt of any concomitant medication contraindicated in pregnancy according to local label within 28 days before screening and between screening and randomisation for non-pregnant subjects and 28 days before conception and between conception and randomisation for pregnant subjects - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or pharmacologically dilated fundoscopy performed within the past 90 days prior to randomisation for non-pregnant subjects or within 28 days prior to randomisation for pregnant subjects. - History of severe hyperemesis gravidarum (requiring hospitalisation)
研究组 & 干预措施
Insulin Degludec
Insulin Degludec once daily and Insulin Aspart 2-4 times daily
干预措施: Insulin degludec (Drug)
Insulin Degludec
Insulin Degludec once daily and Insulin Aspart 2-4 times daily
干预措施: Insulin Aspart (Drug)
Insulin Determir
Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily
干预措施: Insulin Aspart (Drug)
Insulin Determir
Insulin Determir once daily or twice daily and Insulin Aspart 2-4 times daily
干预措施: Insulin detemir (Drug)
结局指标
主要结局
Last Planned Glycosylated Haemoglobin (HbA1c) Prior to Delivery
时间窗: From GW 16 to GW 36
Mean of the HbA1c data collected at gestational week (GW) corresponding to last planned visit prior to delivery is presented. This could be either GW 16, 20, 24, 28, 32, 36. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period started at randomization and ended at the date of trial completion, up to 24 months. The date of trial completion was the date of the final scheduled follow-up visit (delivery + 58 days). For participants who had not attended the follow-up visit, the date of trial completion was the date of the last participant-investigator contact. On-treatment observation period started at the date of first dose of trial product and ended at the date of the last day on trial product, up to 22 months.
次要结局
- Number of Live Born Infants With Birth Weight < 10th Percentile for Gestational Age and Sex (Local References) (Yes/no)(At birth)
- Number of Participants With Pre-eclampsia Defined as New-onset Hypertension Occurring From Gestational Week 20 to Delivery and Simultaneous Proteinuria or Presence of Eclampsia, HELLP Syndrome, or Other Severe Organ Involvement (Yes/no)(From GW 20 to delivery)
- Number of Live Born Infants With Birth Weight > 90th Percentile for Gestational Age and Sex (Local References) [Yes/no](At birth)
- Number of Adverse Events in the Infant(From delivery to final follow-up 30 days after delivery)
- Number of Participants With HbA1c Below or Equal to 6.0% [42 Millimoles Per Mole (mmol/Mol)] From Last Planned HbA1c Prior to Delivery (Yes/no)(From GW 16 to GW 36)
- Number of Participants With HbA1c Below or Equal to 6.5% (48 mmol/Mol) From Last Planned HbA1c Prior to Delivery (Yes/no)(From GW 16 to GW 36)
- Last Planned Fasting Plasma Glucose Prior to Delivery(From GW 16 to GW 36)
- Number of Hypoglycaemic Episodes During the Pregnancy Period(From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months))
- Last Planned Average Post-prandial Glucose Prior to Delivery (Average of Three Main Meals)(From GW 16 to GW 36)
- Number of Adverse Events During Pregnancy Period(From the first day of pregnancy (date of conception) or randomisation to delivery (maximum 23 months))
- Number of Participants With Different Modes of Delivery e.g. Vaginal, Operative Vaginal, Planned Caesarean Section or Unplanned Caesarean Section Delivery(At birth)
- Change in Body Weight From Pregnancy Baseline to Last Planned Visit Prior to Delivery(From pregnancy baseline (corresponding to gestational week 8-13) to last planned visit before delivery (last weight recording before given birth))
- Birth Weight for Live Birth Infants(At birth)
- Birth Weight Standard Deviation (SD) Score for Live Birth Infants(At birth)
- Number of Participants With Pre-term Delivery(At birth)
- Number of Participants Who Developed Sight-threatening Retinopathy (Defined as Proliferative Retinopathy or Maculopathy) From Pregnancy Baseline to the End of Treatment (Yes/no)(From pregnancy baseline (corresponding to GW 8-13) to end of treatment (28 days after delivery))
- Number of Participants Who Developed Sight-threatening Retinopathy Defined as Proliferative Retinopathy or Maculopathy From Treatment Baseline to the End of Treatment (Yes/no)(From treatment baseline (week 0) to end of treatment (28 days after delivery))
- Number of Participants Who Had Perinatal Mortality (Death of Foetus/Infant ) (Yes/no)(Between at least 20 completed GWs before delivery and before 7 completed days after delivery)
- Number of Participants Who Had Neonatal Mortality (Death of Infant) (Yes/no)(Between at least 7 completed days after delivery and before 28 completed days after delivery)
- Number of Participants With Presence of Major Abnormalities (Classified According to European Concerted Action on Congenital Anomalies and Twins (EUROCAT)) in Their Foetus/Infants(At birth)
- Number of Participants With Live Born Infants (Yes/no)(At birth)
- Neonatal Hypoglycaemic Episodes Defined as Plasma Glucose Below or Equal to 1.7 mmol/L (31 mg/dL) or Below or Equal to 2.5 mmol/L (45 mg/dl) (Yes/no)(During between 24 and 48 hours after birth)
- Number of Participants With Early Foetal Death (Delivery Before 20 Completed GWs) (Yes/no)(At birth)