Type 2 diabetes mellitus MedDRA version: 17.0 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
CeQur Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and week 12;Secondary Objective: To evaluate the method used to transition patients to PaQ: •number of preset basal doses tried to achieve the desired fasting BG •number of days taken to identify the preset PaQ basal dose that achieves the desired fasting BG To evaluate the effect of PaQ therapy over a 12-week period in T2D patients on: •SMBG taken by the patient before and 2 hours after each meal and at bedtime •to compare TDD used on injectable insulin therapy and PaQ •to compare the patient’s body weight measurement at baseline and follow-up. To evaluate the effect of PaQ treatment on Patient Reported Outcomes: •SF-36 Health Survey •BIT questionnaire •DTSQs questionnaire Number of PaQ deficiencies that occur and their association with adverse events To evaluate the safety of PaQ: •occurrence and severity of adverse events •number and severity of hypoglycemic episodes •presence and severity of dermal irritation at application site, presence and severity of cannula insertion site infections ;Main Objective: To evaluate the level of glycemic control achieved with 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.;Primary end point(s): A1C, after 12 weeks of treatment with PaQ in patients with T2D | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): glycemic control (SMBG) efficacy, safety/tolerability parameters patient reported outcomes (assessed by 3 validated questionnaires) ;Timepoint(s) of evaluation of this end point: Baseline and week 12 | — |
Countries
Austria
Contacts
Public ContactInvestigator
Medizinische Universität Graz/Endokrinologie und Stoffwechsel
Outcome results
None listed