Type 2 Diabetes
Conditions
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.
Interventions
DEVICEInsulin Pump therapy
Initiation of Insulin pump therapy in patients on \>2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
Sponsors
Animas Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is 18 to 75 years of age, inclusive; 2. Has a clinical diagnosis of type 2 diabetes mellitus; 3. Is anti-glutamic acid decarboxylase (GAD) antibody negative; 4. Has an A1C ≥ 7.0% and ≤ 10.5%; 5. Has a body mass index (BMI) ≥ 25 kg/m2 and ≤ 40 kg/m2; 6. 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 \[Symlin\]. 7. If on concomitant metformin, has serum creatinine \< 1.5 mg/dL (male) or \<1.4 mg/dL (female); 8. If female, has a negative urine pregnancy test
Exclusion criteria
1. Has experienced recurrent severe hypoglycemia (\> 2 episodes) requiring assistance during the past 6 months; 2. 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; 3. Has abnormalities on the screening (Visit 1) 12-lead ECG that are deemed by the investigator to be clinically significant; 4. 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; 5. 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; 6. 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Week 16 | Weight change was evaluated at Week 16 for each cohort and all cohorts combined. |
| 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 |
| 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) |
| 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. |
| 7 point profile | Week 16 | Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined. |
| 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 |
Countries
United States
Outcome results
None listed