A Study to Assess Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).

Detailed Description
-----------------
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (T2DM) who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of three phases: screening/baseline evaluation, transition to PaQ use and optimization, and PaQ treatment period. The use of these phases will allow an orderly transition to PaQ treatment as well as a reliable construct from which to interpret the final data.

Official Title
-----------------
A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: PaQ® Insulin Delivery Device
* Drug: Insulin, Asp(B28)-


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years of age; Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage; Has an A1C ≥ 7.0% and ≤ 11.0%; Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or GLP-1 agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks, (See Section 7.4 for definition of baseline basal bolus therapy); Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device; If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female); If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator; Is clinically euthyroid as judged by the Investigator; Is able to understand and sign the required study documents and comply with the CIP requirements; Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose. Exclusion Criteria: Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator; Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator; Is currently taking or has taken sulfonylureas within the last 2 months; Has a BMI greater than 40 kg/m2; Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months; Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator; Has known clinically significant hypersensitivity to skin adhesives; Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant; Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted); 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 received any investigational drug within 1 month; Has donated blood within 30 days; Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being; Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PaQ® Insulin Delivery Device<br>The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments. | Device: PaQ® Insulin Delivery Device<br>* PaQ is a 3 day insulin delivery device which delivers U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.<br>Drug: Insulin, Asp(B28)-<br>* a fast-acting analog of human insulin<br>* Other names: NovoRapid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) |  | Change from Baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood) |  | Change from Baseline at 8 weeks | 
| Fasting plasma glucose |  | Change from Baseline at 12 weeks | 
| 7-point blood glucose profiles |  | Change from Baseline at 12 weeks | 
| Total daily dose of insulin |  | Change from Baseline at 12 weeks | 
| Body weight |  | Change from Baseline at 12 weeks | 
| Barriers to Insulin Treatment questionnaire | Measures aspects of psychological obstacles to insulin treatment in people with type 2 diabetes. | Change from Baseline at 12 weeks | 
| Diabetes Treatment Satisfaction Questionnaire | Designed to make the initial assessment of total diabetes treatment satisfaction, treatment satisfaction in specific areas, and perceived frequencies of hyperglycemia and hypoglycemia. | Change from Baseline at 12 weeks | 
| Short form 36 Health Survey | It is a generic measure, as opposed to disease specific, which assesses the relative burden of diseases, and differentiates the health benefits produced by a wide range of different treatments. | Change from Baseline at 12 weeks | 
| Adverse events |  | Collected throughout the study, average 14 weeks | 
| Hypoglycemic events |  | Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Insulin, Continuous subcutaneous insulin infusion (CSII), Insulin pumps