This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Animas Corporation
ClinicalTrials.gov Identifier:
NCT00922649
First received: March 13, 2008
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Type 2 Diabetes Drug: Insulin Pump therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Animas Corporation:

Primary Outcome Measures:
  • 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.

  • 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

  • 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.


Secondary Outcome Measures:
  • 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

  • 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.

  • 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

  • Body Weight [ Time Frame: Week 16 ]
    Weight change was evaluated at Week 16 for each cohort and all cohorts combined.

  • 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.

  • 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)


Enrollment: 58
Actual Study Start Date: February 1, 2008
Study Completion Date: January 1, 2009
Primary Completion Date: December 1, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: 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.
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
Drug: 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.
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
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922649

Locations
United States, California
The Regents of the University of California on behalf of its San Diego campus
La Jolla, California, United States, 92093
AMCR Institute, Inc.
San Diego, California, United States, 92026
United States, Georgia
Atlanta Diabetes Associates, Inc.
Atlanta, Georgia, United States, 30309
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States, 83404
United States, Kentucky
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States, 40503
United States, Texas
dgd Research, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Animas Corporation
Investigators
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
Principal Investigator: Sunder Mudaliar, MD University of California, San Diego
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Animas Corporation
ClinicalTrials.gov Identifier: NCT00922649     History of Changes
Other Study ID Numbers: ANM002
Study First Received: March 13, 2008
Last Updated: July 28, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017