Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Insulin Pump therapy
- Registration Number
- NCT00922649
- Lead Sponsor
- Animas Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Insulin Pump therapy Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of ≥ 2 OAs C Insulin Pump therapy Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen basal-bolus insulin ± OAs B Insulin Pump therapy Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of basal insulin ± OAs
- Primary Outcome Measures
Name Time Method Insulin doses at Week 16 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 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 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.
- Secondary Outcome Measures
Name Time Method Change from baseline to week 16 in Patient Reported Outcomes (PROs) Week 16 PROs were assessed at Baseline, Wk 8 (except for EQ-5D) and Wk 16, including EuroQol-5 Dimensions (EQ-5D) (Generic health-related QoL), Diabetes Symptom Checklist-Revised (DSC-R) (Diabetes-specific QoL), and Insulin Delivery System Rating Questionnaire (IDSRQ) (Treatment Satisfaction with insulin delivery system)
CGM Glucose Ranges - Percent of Measurements End of study The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
A1C (Hemoglobin A1c) Week 16 To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
7 point profile Week 16 Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.
Body Weight Week 16 Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
Hypoglycemia Week 16 The incidence (percent of patients with at least one episode of hypoglycemia) of minor hypoglycemia was evaluated respectively. Minor hypoglycemia was defined as symptoms consistent with hypoglycemia that either resolved spontaneously or upon self-treatment with oral carbohydrate. Severe hypoglycemia referred to symptoms consistent with hypoglycemia during which the patient required the assistance of another individual and was associated with a documented glucose concentration less than 56 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon.
Trial Locations
- Locations (6)
Atlanta Diabetes Associates, Inc.
🇺🇸Atlanta, Georgia, United States
Kentucky Diabetes Endocrinology Center
🇺🇸Lexington, Kentucky, United States
dgd Research, Inc.
🇺🇸San Antonio, Texas, United States
The Regents of the University of California on behalf of its San Diego campus
🇺🇸La Jolla, California, United States
AMCR Institute, Inc.
🇺🇸San Diego, California, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
🇺🇸Idaho Falls, Idaho, United States