Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
NCT ID: NCT00922649
Last Updated: 2017-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2008-02-01
2009-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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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
Insulin 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.
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
Insulin 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.
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
Insulin 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.
Interventions
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Insulin 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.
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
Yes
Sponsors
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Animas Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Bailey, MD
Role: PRINCIPAL_INVESTIGATOR
AMCR Institute, Inc.
Bruce Bode, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Diabetes Associates, Inc.
Mark Kipnes, MD
Role: PRINCIPAL_INVESTIGATOR
dgd Research, Inc.
John Liljenquist, MD
Role: PRINCIPAL_INVESTIGATOR
Rocky Mountain Diabetes and Osteoporosis Center, PA
Lyle Myers, M.D
Role: PRINCIPAL_INVESTIGATOR
Kentucky Diabetes Endocrinology Center
Sunder Mudaliar, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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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
Atlanta Diabetes Associates, Inc.
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
dgd Research, Inc.
San Antonio, Texas, United States
Countries
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References
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Peyrot M, Rubin RR, Chen X, Frias JP. Associations between improved glucose control and patient-reported outcomes after initiation of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011 Apr;13(4):471-6. doi: 10.1089/dia.2010.0167. Epub 2011 Feb 28.
Rubin RR, Peyrot M, Chen X, Frias JP. Patient-reported outcomes from a 16-week open-label, multicenter study of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2010 Nov;12(11):901-6. doi: 10.1089/dia.2010.0075. Epub 2010 Sep 30.
Other Identifiers
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ANM002
Identifier Type: -
Identifier Source: org_study_id