Efficacy of Exenatide-LAR Alone and in Combination With Dapagliflozin in Overweight/Obese, Insulin Treated Patients With Uncontrolled Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The purpose of this study is to see what the effects of using one or two additional diabetes drugs (dapagliflozin and exenatide-LAR) are on blood sugar levels in patients who are taking insulin. This research study is being done to investigate which of these commonly-used medications, medication combinations or increasing insulin dose is better.
详细描述
This is a single center prospective, randomized, placebo-controlled trial in overweight/obese patients with insulin treated uncontrolled type 2 diabetes
Eligible subjects willing to participate in the study will be randomized to one of 3 treatment groups:
Group 1: Insulin titration + behavioral therapy Basal insulin titration upto 12 weeks with 2 U increment every 3 days (Fasting glucose goal <110) based on self-monitored blood glucose.
After 12 weeks, patients with HbA1c >8% will switch to a basal bolus regimen.
Group 2: Exenatide-LAR 2mg q week x 24 weeks + Dapagliflozin placebo x 52 weeks + titrated basal insulin +behavioral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- •History of type 1 diabetes
- •fasting c-peptide <.8 ng/ml
- •eGFR <60 ml/min/1.73 m^2
- •urine albumin-to-creatinine ratio greater or equal to 300 mg/g
- •AST/ALT greater or equal to 2.5 upper limits of normal
- •history of infectious liver disease (HBV, HCV)
- •creatine kinase greater or equal to 3 times the upper limits of normal
- •unstable or serious cardiovascular, renal, or hepatic disease
- •symptoms of severely uncontrolled diabetes
- •history of more than 1 episode of severe/major hypoglycemia within 6 months, active/history of bladder cancer
- •female patients who are pregnant or intending to become pregnant
- •women who are breastfeeding
- •personal/family history of medullary thyroid cancer or MEN2
- •fasting triglyceride levels > 500 mg/dl
- •history of confirmed pancreatitis
- •known hypersensitivity or allergy to exenatide or dapagliflozin
- •are currently enrolled in or discontinued within last 30 days from another study
- •have any other condition that precludes the patient from following and completing the protocol
- •history of diabetic ketoacidosis
- •anti-diabetes medication other than those listed in the inclusion criteria within 8 weeks of screening
- •history of previous bariatric surgery or planned bariatric surgery during the course of the study
- •clinically significant abnormal free T4/TSH requiring initiation or adjustment of thyroid treatment
研究组 & 干预措施
Group 1
Insulin titration and behavioral therapy.
干预措施: Insulin Titration (Drug)
Group 1
Insulin titration and behavioral therapy.
干预措施: Behavioral Therapy (Behavioral)
Group 2
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
干预措施: Exenatide-LAR plus Dapagliflozin placebo (Drug)
Group 2
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
干预措施: Insulin Titration (Drug)
Group 2
Exenatide-LAR plus Dapagliflozin placebo, basal insulin titration, and behavioral therapy.
干预措施: Behavioral Therapy (Behavioral)
Group 3
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
干预措施: Exenatide-LAR plus Dapagliflozin (Drug)
Group 3
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
干预措施: Insulin Titration (Drug)
Group 3
Exenatide-LAR plus Dapagliflozin, basal insulin titration, and behavioral therapy.
干预措施: Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: baseline, 24 weeks
To determine the efficacy of Exenatide-LAR and Exenatide-LAR plus dapagliflozin in lowering HbA1c compared with insulin titration in obese, insulin treated subjects with uncontrolled Type 2 Diabetes Mellitus at 24 weeks
次要结局
- Change in total dose insulin(baseline, 24 weeks)
- Change in fasting lipids(baseline, 24 weeks)
- Change in Body Weight(baseline, 24 weeks)
- Change in waist circumference(baseline, 24 weeks)
- Change in fasting glucose(baseline, 24 weeks)
- Change in blood pressure(baseline, 24 weeks)