Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
研究概览
简要总结
The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present with type 2 diabetes mellitus
- •Have been taking metformin and/or pioglitazone
- •Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
- •Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
- •Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter [mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
- •Not pregnant or breastfeeding
排除标准
- •Have Type 1 Diabetes
- •Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
- •Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
- •Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
- •Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
- •Have cardiac disease with a functional status that is Class III or IV
- •Have a history of renal or liver disease
- •Have had a blood transfusion or have a blood disorder
研究组 & 干预措施
Insulin lispro low mixture (LM)
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25
干预措施: Insulin Lispro Low Mixture (LM) (Drug)
Insulin glargine+insulin lispro
Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro
干预措施: Insulin Glargine (Drug)
Insulin glargine+insulin lispro
Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro
干预措施: Prandial Insulin Lispro (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
时间窗: Baseline, 24 weeks
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)
时间窗: Baseline, 24 weeks
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
次要结局
- Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint(Baseline, 12 weeks)
- Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks(24 weeks)
- Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks(Baseline, 12 weeks, and 24 weeks)
- 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks(12 weeks, 24 weeks)
- Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks(12 weeks, 24 weeks)
- Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks(12 weeks, 24 weeks)
- Change in Weight From Baseline to 12 Weeks and 24 Weeks(Baseline, 12 weeks, 24 weeks)
- The Number of Participants With a Hypoglycemic Episodes (Incidence)(Baseline through 24 weeks)
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks(24 weeks)
- Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks(24 weeks)
- The Rate of Hypoglycemic Episodes(Baseline through 24 weeks)
- The Number of Participants With Severe Hypoglycemic Episodes(Baseline through 24 weeks)