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Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDNA

Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

NCT00922649•Animas Corporation

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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;

Locations (6)

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

Key Dates

Start Date

February 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

January 1, 2009

Last Updated

September 21, 2017

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Insulin Pump therapy

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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High Intensity Interval Training and Insulin Sensitivity in Type 2 Diabetes

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