E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053247 |
E.1.2 | Term | Insulin-requiring type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the transition of patients from basal bolus insulin therapy to PaQ
2. To evaluate the effect of basal bolus therapy with PaQ over a 12-week period in patients with T2DM
3. To evaluate the effect of PaQ treatment on the Patient Reported Outcomes (PROs)
4. To track the number of PaQ deficiencies (use errors and device malfunctions) that occur and their association with adverse events
5. To evaluate the safety of PaQ |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
A1c, after 12 weeks of treatment with PaQ in patients with T2D |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
glycemic control (SMBG)
efficacy, safety/tolerability parameters
patient reported outcomes (assessed by 3 validated questionnaires) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |