Study to investigate the performance of a newly developed patch insulin pump in patients with type 2 diabetes

Phase 1

• Conditions: MedDRA version: 17.1Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Type 2 diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004078-40-AT
• Lead Sponsor: CeQur Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-22
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Is at least 18 years of age;
2.Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage;
3.Has an A1C = 7.0% and ? 11.0%;
4.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);
5.Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device;
6.If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female);
7.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;
8.Is clinically euthyroid as judged by the Investigator;
9.Is able to understand and sign the required study documents and comply with the CIP requirements;
10.Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator;
2.Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator;
3.Is currently taking or has taken sulfonylureas within the last 2 months;
4.Has a BMI greater than 40 kg/m2;
5.Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
6.Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator;
7.Has known clinically significant hypersensitivity to skin adhesives;
8.Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant;
9.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);
10.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;
11.Has received any investigational drug within 1 month;
12.Has donated blood within 30 days;
13.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;
14.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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the performance of PaQ, as measured by A1C, after 12 weeks of treatment in patients with T2DM who are currently on basal bolus insulin therapy taking at least 2 insulin injections per day;Secondary Objective: 1.To evaluate the transition of patients from basal bolus insulin therapy to PaQ<br>2.To evaluate the effect of basal bolus therapy with PaQ over a 12-week period in patients with T2DM <br>3.To evaluate the effect of PaQ treatment on the Patient Reported Outcomes (PROs) <br>4.To track the number of PaQ deficiencies (use errors and device malfunctions) that occur and their association with adverse events<br>5.To evaluate the safety of PaQ;Primary end point(s): A1c, after 12 weeks of treatment with PaQ in patients with T2D;Timepoint(s) of evaluation of this end point: Baseline and week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): glycemic control (SMBG)<br>efficacy, safety/tolerability parameters<br>patient reported outcomes (assessed by 3 validated questionnaires);Timepoint(s) of evaluation of this end point: Baseline and week 12