Status:
COMPLETED
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Lead Sponsor:
Animas Corporation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
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) ≥ ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00922649
Start Date
February 1 2008
End Date
January 1 2009
Last Update
September 21 2017
Active Locations (6)
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1
The Regents of the University of California on behalf of its San Diego campus
La Jolla, California, United States, 92093
2
AMCR Institute, Inc.
San Diego, California, United States, 92026
3
Atlanta Diabetes Associates, Inc.
Atlanta, Georgia, United States, 30309
4
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States, 83404