- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922649
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
September 20, 2017 updated by: Animas Corporation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- The Regents of the University of California on behalf of its San Diego campus
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San Diego, California, United States, 92026
- AMCR Institute, Inc.
-
-
Georgia
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Atlanta, Georgia, United States, 30309
- Atlanta Diabetes Associates, Inc.
-
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes and Osteoporosis Center, PA
-
-
Kentucky
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Lexington, Kentucky, United States, 40503
- Kentucky Diabetes Endocrinology Center
-
-
Texas
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San Antonio, Texas, United States, 78229
- Dgd Research, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
Other: 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
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
Other: 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
|
Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin doses at Week 16
Time Frame: 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.
|
Week 16
|
Ratio of Basal-to-Bolus Insulin Dose at Week 16
Time Frame: 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
|
16 weeks
|
Number of daily basal rates at Week 16
Time Frame: 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.
|
Week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A1C (Hemoglobin A1c)
Time Frame: Week 16
|
To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
|
Week 16
|
7 point profile
Time Frame: Week 16
|
Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.
|
Week 16
|
CGM Glucose Ranges - Percent of Measurements
Time Frame: End of study
|
The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
|
End of study
|
Body Weight
Time Frame: Week 16
|
Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
|
Week 16
|
Hypoglycemia
Time Frame: 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.
|
Week 16
|
Change from baseline to week 16 in Patient Reported Outcomes (PROs)
Time Frame: 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)
|
Week 16
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sunder Mudaliar, MD, University of California, San Diego
- Principal Investigator: Timothy Bailey, MD, AMCR Institute, Inc.
- Principal Investigator: Bruce Bode, MD, Atlanta Diabetes Associates, Inc.
- Principal Investigator: Mark Kipnes, MD, Dgd Research, Inc.
- Principal Investigator: John Liljenquist, MD, Rocky Mountain Diabetes and Osteoporosis Center, PA
- Principal Investigator: Lyle Myers, M.D, Kentucky Diabetes Endocrinology Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
March 13, 2008
First Submitted That Met QC Criteria
June 16, 2009
First Posted (Estimate)
June 17, 2009
Study Record Updates
Last Update Posted (Actual)
September 21, 2017
Last Update Submitted That Met QC Criteria
September 20, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANM002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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