NCT00664534已完成4 期
Comparison of Premixed Insulin Lispro Low-Mixture and Mid-Mixture Regimens With Separate Basal and Bolus Insulin Injections in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Oral Therapy Who Consume Light Breakfast
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
研究概览
简要总结
This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
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
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus, Type 2
- •have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
- •glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
- •regularly consume a light breakfast (less than 15% of total daily calorie intake)
- •capable and willing to follow the protocol
- •give written consent
排除标准
- •are taking a TZD whose country label does not allow in combination with insulin
- •are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
- •have a body mass index greater than 40 kg/m^2
- •have a history of severe hypoglycemia in past 24 weeks
- •are pregnant or may become pregnant
- •women who are breastfeeding
- •have significant cardiac disease
- •have significant renal or liver disease
- •undergoing therapy for a malignancy
- •contraindications to study medications
- •have an irregular sleep/wake cycle
研究组 & 干预措施
Glargine
Active Comparator
Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)
干预措施: Insulin Glargine (Drug)
Premixed Insulin Lispro
Experimental
Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs
干预措施: Insulin Lispro Premix (mid-mixture and low-mixture) (Drug)
结局指标
主要结局
Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint
时间窗: 48 weeks
Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population.
次要结局
- 7-point Self-monitored Blood Glucose Profiles(16 weeks, 32 weeks and 48 weeks)
- Body Weight Change From Baseline to Endpoint(baseline, 48 weeks)
- Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time(16 weeks, 32 weeks and 48 weeks)
- Incidence of All Self-reported Hypoglycemic Episodes(Baseline to 48 weeks)
- Rate Per 30 Days of All Self-reported Hypoglycemic Episodes(Baseline to 48 weeks)
- Number of Participants With Adverse Events(Baseline to 48 weeks)
- Percentage of Participants Using Each Possible Final Insulin Regimen(48 weeks)
- HbA1c Over Time(16 weeks, 32 weeks, and 48 weeks)
- Mean Postprandial Blood Glucose Values(Baseline, 16 weeks, 32 weeks and 48 weeks)
- Mean Daily Total, Basal and Prandial Insulin Dose(16 weeks, 32 weeks and 48 weeks)
研究者
研究点 (1)
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进行中（未招募）
不适用
Comparison of Premixed Insulin Lispro Low Mixture and Mid Mixture Regimens with Separate Basal and Bolus Insulin Injections in Patients with Type 2 Diabetes with Inadequate Glycemic Control on Oral Therapy who Consume Light BreakfastEUCTR2007-005061-36-PTEli Lilly and Company Ltd.325