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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | 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 demonstrate the ease of use of the U300 pen injector in pen-naïve
and insulin-naïve type 2 diabetes mellitus (T2DM) patients in a 4-week
once-daily dosing regimen with HOE901-U300. |
|
E.2.2 | Secondary objectives of the trial |
To assess in a 4-week once-daily dosing regimen with HOE901-U300 in pen-naïve and insulin-naïve T2DM patients.
The safety and usability of the U300 pen injector.
The glycemic control with the U300 pen injector.
The safety of HOE901-U300 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with T2DM inadequately controlled with non-insulin, noninjectable antihyperglycemic drug(s) and for whom the
Investigator/treating physicians has decided that basal insulin is appropriate.
Signed written informed consent. |
|
E.4 | Principal exclusion criteria |
Glycated hemoglobin A1c (HbA1c) <7.0% (<53 mmol/mol) or >11% (97 mmol/mol) at screening.
Age <18 years at the time of screening.
Body Mass Index (BMI) >40 kg/m2.
Diabetes other than T2DM.
History of T2DM for less than 1 year before screening.
Less than 6 months anti-hyperglycemic treatment before screening.
Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonist.
Patients receiving only non-insulin anti-hyperglycemic drugs not approved for combination with insulin according to local labeling/local treatment guidelines and/or sulfonylurea or glinides.
Current or previous insulin use except for a maximum of 8 consecutive days and a total of 14 days (eg, acute illness, surgery) during the last year prior to screening.
Any contraindication to insulin glargine (Lantus) according to the National Product labeling or any excipients.
Any contraindication to the mandatory background non-insulin antihyperglycemic medication according to the respective National Product labeling.
Latest eye examination by an ophthalmologist >12 months prior to inclusion.
More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months.
Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Ease-of-use / ease of learning questionnaire |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
2) Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4
3) Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4
4) Number of participants with Product Technical Complaints (PTC)
5) Number of participants with adverse events and hypoglycemic events related to PTC
6) Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary)
7) Number of participants with adverse events
8) Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association
9) Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG)
10) Number of participants with site injection site reactions / hypersensitivity reactions |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 2) 3) 6) Baseline, week 4
4) 5) Baseline to week 4
7) 8) 10) screening to week 6
9) screening, baseline, week 4 |
|
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 | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
To demonstrate the ease of use of the HOE901 - new formulation in pen-naïve patients with T2DM |
|
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |