Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 12
- 主要终点
- Insulin doses at Week 16
研究概览
简要总结
16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3) basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Is 18 to 75 years of age, inclusive;
- •Has a clinical diagnosis of type 2 diabetes mellitus;
- •Is anti-glutamic acid decarboxylase (GAD) antibody negative;
- •Has an A1C ≥ 7.0% and ≤ 10.5%;
- •Has a body mass index (BMI) ≥ 25 kg/m2 and ≤ 40 kg/m2;
- •Is treated with either ≥ 2 oral antidiabetic agents (OA) or basal insulin ± OA(s) or basal-bolus insulin ± OA(s) for at least 3 months (Subjects may also be treated with exenatide [Byetta] or pramlintide [Symlin].
- •If on concomitant metformin, has serum creatinine < 1.5 mg/dL (male) or <1.4 mg/dL (female);
- •If female, has a negative urine pregnancy test
排除标准
- •Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
- •Has clinical cardiovascular disease (CVD) as evidenced by prior myocardial infarction, stroke, arterial revascularization and/or angina with ischemic changes on ECG at rest, changes on graded exercise test, or positive cardiac imaging test results;
- •Has abnormalities on the screening (Visit 1) 12-lead ECG that are deemed by the investigator to be clinically significant;
- •Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route or potent inhaled,intrapulmonary, intranasal, or topical steroids that are known to have a high rate of systemic absorption;
- •Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be non-compliant;
- •Has any significant medical condition, laboratory findings, or medical history that in the investigator's opinion may affect successful completion of the study and/or personal well-being;
结局指标
主要结局
Insulin doses at Week 16
时间窗: Week 16
To evaluate insulin doses after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.This included the total daily insulin dose, basal and bolus insulin doses.
Ratio of Basal-to-Bolus Insulin Dose at Week 16
时间窗: 16 weeks
Evaluate insulin dosing patterns after 16 weeks of insulin pump therapy aimed at safely achieving normal or near-normal glycemic control in patients with type 2 diabetes
Number of daily basal rates at Week 16
时间窗: Week 16
To evaluate insulin dosing patterns, i.e., number of daily basal rates, after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.
次要结局
- Change from baseline to week 16 in Patient Reported Outcomes (PROs)(Week 16)
- CGM Glucose Ranges - Percent of Measurements(End of study)
- A1C (Hemoglobin A1c)(Week 16)
- 7 point profile(Week 16)
- Body Weight(Week 16)
- Hypoglycemia(Week 16)