The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Mean Change From Randomization in A1c at Week 26
研究概览
简要总结
The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).
详细描述
The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. The investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching A1c levels <7.0%, while more patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c levels <7.0% without severe hypoglycemia or significant weight gain.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes with confirmed HbA1c level >10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis.
排除标准
- •Age <18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed;
- •Type 1 diabetes as purposefully withholding meal-time insulin is contraindicated;
- •Clinical state requiring inpatient admission/treatment;
- •Contraindication or strong cautions to any of the study medications:
- •Creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label)
- •History of lactic acidosis (per metformin label)
- •Advanced hepatic or cardiac disease (per metformin label)
- •Age >80 years (per metformin label)
- •Chronic alcohol use (>14 drinks/week)
- •History of pancreatitis (per liraglutide label)
- •Personal or family history of medullary thyroid cancer or MEN syndrome (per liraglutide label)
- •Pregnancy and lactation (per liraglutide label)
- •Any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement;
- •Any scheduled elective procedures/surgeries;
- •Active infections, including osteomyelitis;
- •Not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to Randomization (visit 1)and the week prior to visit 6
- •Non English speaking.
研究组 & 干预措施
Control: Metformin, Insulin Detemir, Insulin Aspart
Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician
干预措施: Metformin (Drug)
Control: Metformin, Insulin Detemir, Insulin Aspart
Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician
干预措施: Detemir (Drug)
Control: Metformin, Insulin Detemir, Insulin Aspart
Metformin titrated to max tolerated dose (at least 1000 mg/day); Insulin detemir titrated based on the study protocol; Insulin Aspart titrated by the physician
干预措施: Insulin Aspart (Drug)
Metformin, insulin determir, Liraglutide
Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)
干预措施: Metformin (Drug)
Metformin, insulin determir, Liraglutide
Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)
干预措施: Detemir (Drug)
Metformin, insulin determir, Liraglutide
Metformin titrated to max tolerated dose (at least 1000mg/day); Insulin detemir titrated based on the study protocol"; Liraglutide titrated to max tolerated dose (at least 1.2 mg/day)
干预措施: Liraglutide (Drug)
结局指标
主要结局
Mean Change From Randomization in A1c at Week 26
时间窗: Baseline and Week 26
Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy
次要结局
- Composite End-point(Week 0 (Randomization) , Week 26)
- Percentage of Participants Reaching Target A1c of <7% at Week 26(Week 26)
- Mean Change From Randomization in Body Weight(Week 0 (Randomization) , Week 26)
- Change in Short Form-36 (SF-36) Questionnaire Score(Week 0 (Randomization) , Week 26)
- Percentage of Participants Reaching Pre-specified "Treatment Failure" Outcome(week 13)
- Hypoglycemic Episodes(Week 0 (Randomization) , Week 2, week 4, week 13, Week 26)
- Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means(Week 0 (Randomization) , Week 26)
研究者
Ildiko Lingvay
MD
University of Texas Southwestern Medical Center