Clinical trial NCT00922649: Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Official title: Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Animas Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Insulin doses at Week 16
timeFrame: Week 16
measure: Ratio of Basal-to-Bolus Insulin Dose at Week 16
timeFrame: 16 weeks
measure: Number of daily basal rates at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: A1C (Hemoglobin A1c)
timeFrame: Week 16
measure: 7 point profile
timeFrame: Week 16
measure: CGM Glucose Ranges - Percent of Measurements
timeFrame: End of study
measure: Body Weight
timeFrame: Week 16
measure: Hypoglycemia
timeFrame: Week 16
measure: Change from baseline to week 16 in Patient Reported Outcomes (PROs)
timeFrame: Week 16
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Regents of the University of California on behalf of its San Diego campus
state: California
city: San Diego
country: United States
facility: AMCR Institute, Inc.
state: California
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates, Inc.
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center, PA
state: Idaho
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: San Antonio
country: United States
facility: dgd Research, Inc.
state: Texas
Study officials:
affiliation: AMCR Institute, Inc.
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Diabetes Associates, Inc.
name: Bruce Bode, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: dgd Research, Inc.
name: Mark Kipnes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rocky Mountain Diabetes and Osteoporosis Center, PA
name: John Liljenquist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kentucky Diabetes Endocrinology Center
name: Lyle Myers, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Sunder Mudaliar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.