Back to resultsPilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin Pump therapy
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 2 Diabetes
Eligibility Criteria
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;
Sites / Locations
- The Regents of the University of California on behalf of its San Diego campus
- AMCR Institute, Inc.
- Atlanta Diabetes Associates, Inc.
- Rocky Mountain Diabetes and Osteoporosis Center, PA
- Kentucky Diabetes Endocrinology Center
- dgd Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
A
B
C
Arm Description
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 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 naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen basal-bolus insulin ± OAs
Outcomes
Primary Outcome Measures
Insulin doses at 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
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
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 Outcome Measures
A1C (Hemoglobin A1c)
To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
7 point profile
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
The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
Body Weight
Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
Hypoglycemia
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.
Change from baseline to week 16 in Patient Reported Outcomes (PROs)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922649
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2008 (Actual)
Primary Completion Date
December 1, 2008 (Actual)
Study Completion Date
January 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Animas Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
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
Arm Title
B
Arm Type
Other
Arm Description
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
Arm Title
C
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Insulin Pump therapy
Intervention Description
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
Primary Outcome Measure Information:
Title
Insulin doses at Week 16
Description
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.
Time Frame
Week 16
Title
Ratio of Basal-to-Bolus Insulin Dose at Week 16
Description
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
Time Frame
16 weeks
Title
Number of daily basal rates at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
A1C (Hemoglobin A1c)
Description
To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
Time Frame
Week 16
Title
7 point profile
Description
Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.
Time Frame
Week 16
Title
CGM Glucose Ranges - Percent of Measurements
Description
The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
Time Frame
End of study
Title
Body Weight
Description
Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
Time Frame
Week 16
Title
Hypoglycemia
Description
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.
Time Frame
Week 16
Title
Change from baseline to week 16 in Patient Reported Outcomes (PROs)
Description
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)
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Bailey, MD
Organizational Affiliation
AMCR Institute, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruce Bode, MD
Organizational Affiliation
Atlanta Diabetes Associates, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Kipnes, MD
Organizational Affiliation
dgd Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Liljenquist, MD
Organizational Affiliation
Rocky Mountain Diabetes and Osteoporosis Center, PA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lyle Myers, M.D
Organizational Affiliation
Kentucky Diabetes Endocrinology Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sunder Mudaliar, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Regents of the University of California on behalf of its San Diego campus
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
AMCR Institute, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Atlanta Diabetes Associates, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Rocky Mountain Diabetes and Osteoporosis Center, PA
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Kentucky Diabetes Endocrinology Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
dgd Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21355725
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.
Results Reference
derived
PubMed Identifier
20879963
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.
Results Reference
derived
Learn more about this trial
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
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