NCT00922649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

September 21, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

March 13, 2008

Last Update Submit

September 20, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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.

    Week 16

  • 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

    16 weeks

  • 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.

    Week 16

Secondary Outcomes (6)

  • A1C (Hemoglobin A1c)

    Week 16

  • 7 point profile

    Week 16

  • CGM Glucose Ranges - Percent of Measurements

    End of study

  • Body Weight

    Week 16

  • Hypoglycemia

    Week 16

  • +1 more secondary outcomes

Study Arms (3)

A

OTHER

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

B

OTHER

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

C

OTHER

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

Interventions

Insulin Pump therapyDEVICE

Initiation of Insulin pump therapy in patients on \>2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.

ABC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Regents of the University of California on behalf of its San Diego campus

La Jolla, California, 92093, United States

Location

AMCR Institute, Inc.

San Diego, California, 92026, United States

Location

Atlanta Diabetes Associates, Inc.

Atlanta, Georgia, 30309, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center, PA

Idaho Falls, Idaho, 83404, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

  • 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.

    PMID: 21355725DERIVED

  • 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.

    PMID: 20879963DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2008

First Posted

June 17, 2009

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

September 21, 2017

Record last verified: 2017-09

Locations

US(6)