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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • La Jolla, California, United States, 92093
        • The Regents of the University of California on behalf of its San Diego campus
      • San Diego, California, United States, 92026
        • AMCR Institute, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Associates, Inc.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center, PA
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Kentucky Diabetes Endocrinology Center
    • Texas
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: 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.
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
Device: 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.
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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Animas Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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