Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922649
• Other study ID #: ANM002
• Status: Completed
• Phase: N/A
• First received: March 13, 2008
• Last updated: September 20, 2017
• Start date: February 1, 2008
• Est. completion date: January 1, 2009

Study information

• Verified date: September 2017
• Source: Animas Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 1, 2009
• Est. primary completion date: December 1, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates, Inc.	Atlanta	Georgia
United States	Rocky Mountain Diabetes and Osteoporosis Center, PA	Idaho Falls	Idaho
United States	The Regents of the University of California on behalf of its San Diego campus	La Jolla	California
United States	Kentucky Diabetes Endocrinology Center	Lexington	Kentucky
United States	dgd Research, Inc.	San Antonio	Texas
United States	AMCR Institute, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Animas Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	A1C (Hemoglobin A1c)	To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome	Week 16
Secondary	7 point profile	Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.	Week 16
Secondary	CGM Glucose Ranges - Percent of Measurements	The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM	End of study
Secondary	Body Weight	Weight change was evaluated at Week 16 for each cohort and all cohorts combined.	Week 16
Secondary	Hypoglycemia	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
Secondary	Change from baseline to week 16 in Patient Reported Outcomes (PROs)	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