NCT00510952已完成3 期
The PERSISTENT Trial: A Prospective Randomized Trial Comparing Insulin Lispro Protamine Suspension to Insulin Glargine in Patients With Type 2 Diabetes on Anti-hyperglycemic Medications
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.
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
- •Have type 2 diabetes mellitus for at least 1 year.
- •Are greater than or equal to 18 years old.
- •Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1: Metformin- Sulfonylureas-Dipeptidyl peptidase-IV (DPP-IV) inhibitors-Thiazolidinediones (TZDs)
- •Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit
- •Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kg/meter squared.
排除标准
- •Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
- •Have taken any glucose-lowering medications not included in Inclusion Criterion #3; (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit
- •Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
- •Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- •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.
研究组 & 干预措施
Lispro
Experimental
Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
干预措施: Insulin Lispro Protamine Suspension (Drug)
Glargine
Active Comparator
Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
干预措施: Insulin Glargine (Drug)
结局指标
主要结局
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
时间窗: Baseline, 24 Weeks
次要结局
- Percentage of Patients With HbAlc Less Than 7.0 Percent and HbAlc Less Than or Equal to 6.5 Percent at Endpoint(24 weeks)
- 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall(Baseline to 24 Weeks)
- 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe) Overall(Baseline to 24 weeks)
- Glycemic Variability at Endpoint(24 weeks)
- Number of Participants With Self-Reported Hypoglycemic Episodes (Including All, Nocturnal, and Severe Hypoglycemia) Overall(Baseline to 24 weeks)
- Change in Absolute Body Weight (kg) From Baseline to 24 Week Endpoint(Baseline, 24 weeks)
- Total Daily Insulin Dose (Units) at Endpoint(24 weeks)
- Actual and Change From Baseline to 12 Week and 24 Week Endpoint in HbAlc Value(Baseline, 12 Weeks, 24 Weeks)
- 7-Point Self-Monitored Blood Glucose (SMBG) Profile at Endpoint(24 weeks)
- Total Daily Insulin Dose Per Body Weight (Units/Kilograms) at Endpoint(24 Weeks)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise CapacityMyocardial DiseasesCoronary Artery DiseaseCongestive Heart FailureIschemic CardiomyopathyNCT00326690BioVentrix
已完成
3 期
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)Opioid-induced Bowel DysfunctionNCT01298219Sucampo Pharma Americas, LLC439
已完成
不适用
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on GingivitisGingivitisNCT01811316Sunstar Americas62
已完成
3 期
A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar DisorderBipolar DisorderNCT00246246Janssen-Ortho Inc., Canada48
已完成
3 期
Opioid-induced Bowel Dysfunction Pivotal Assessment of LubiprostoneOpioid-Induced Bowel DysfunctionNCT00597428Sucampo Pharma Americas, LLC437