Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Animas Corporation
- Enrollment
- 58
- Locations
- 6
- Primary Endpoint
- Insulin doses at Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Arms & Interventions
A
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
Intervention: Insulin Pump therapy (Device)
B
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
Intervention: Insulin Pump therapy (Device)
C
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
Intervention: Insulin Pump therapy (Device)
Outcomes
Primary Outcomes
Insulin doses at Week 16
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- A1C (Hemoglobin A1c)(Week 16)
- Change from baseline to week 16 in Patient Reported Outcomes (PROs)(Week 16)
- CGM Glucose Ranges - Percent of Measurements(End of study)
- 7 point profile(Week 16)
- Body Weight(Week 16)
- Hypoglycemia(Week 16)