Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
详细描述
Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL [neutral protamine Hagedorn]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for one year or more
- •Age 18 years or older
- •Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
- •Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
- •As determined by the investigator, are capable and willing to do the following:
- •perform self monitoring of blood glucose (SMBG),
- •complete patient diaries as required for this protocol,
- •use the insulin injection device(s) according to the instructions provided,
- •are receptive to diabetes education,
- •comply with the required study visits.
排除标准
- •Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit
- •Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
- •Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
研究组 & 干预措施
Insulin Lispro Protamine Suspension
Insulin Lispro Protamine Suspension twice daily
干预措施: Insulin Lispro Protamine Suspension (Drug)
Detemir
Insulin Levemir (detemir) subcutaneous (SC) twice daily.
干预措施: Insulin Levemir (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
时间窗: baseline and 32 weeks
次要结局
- Glycemic Variability at Endpoint(32 Weeks)
- Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values(Baseline, 8,16, 24, 32 Weeks)
- Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint(Baseline to 32 Weeks)
- Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%(32 Weeks)
- 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint(baseline to 32 weeks)
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint(baseline to 32 weeks)
- Change From Baseline in Absolute Body Weight at 32 Week Endpoint(Baseline, 32 Weeks)
- Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])(32 Weeks)
- Insulin Dose (Total and By Component [Basal and Bolus])(32 weeks)
- 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint(32 Weeks)