| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Type 2 Diabetes Mellitus (T2DM) |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Not possible to specify |
| MedDRA Classification |
| 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 compare the change in A1C, with bolus insulin dosing with Finesse versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy. |
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| E.2.2 | Secondary objectives of the trial |
•To compare the change in other parameters of glycemic control with bolus insulin dosing with Finesse versus pen, from baseline to the completion of 24 weeks and 44 weeks of basal and bolus insulin therapy.
•To demonstrate that patient reported outcomes (PRO) improve with Finesse versus pen following the completion of 24 weeks and 44 weeks of basal and bolus insulin therapy.
•To demonstrate that HCPs prefer Finesse to pen for initiation of bolus insulin therapy following the completion of 24 weeks of basal and bolus insulin therapy by the last patient at their investigative site.
•To demonstrate the durability of effect of using Finesse and pen on maintenance of A1C from week 24 to week 44
of basal and bolus insulin therapy.
•To demonstrate that patients prefer Finesse to pen for bolus insulin therapy following a 4-week crossover from week 44 to week 48.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
a) Patient is willing to provide written informed consent prior to enrollment and agrees to follow the protocol.
b) Age 22 – 75 years.
c) Known clinical diagnosis of type 2 diabetes according to ADA/EASD 31, 32 criteria. d) Treated with basal insulin for ≥ 6 months (e.g., Lantus® [Glargine], Levemir®
[Detemir], Tresiba® [Degludec], and NPH [Neutral Protamine Hagedorn]), with current dose stable for ≥ 6 weeks at ≥ 0.3 U/kg/day not to exceed 100U/day, with/without any combination of AHA, and in whom the HCP feels advancement from basal to basal and bolus therapy is needed for the patient. Note: if basal
insulin dose is < 0.3 U/kg/day at visit 1, and, if clinically indicated (e.g., based on A1C, FPG), the Investigator and/or patient’s HCP is encouraged to adjust basal insulin to doses ≥ 0.3 U/kg and re-screen in ≥ 2months after the first screen.
e) A1C 7.5-11.0% at screening visit 1. Note: To account for A1C assay variability, per investigator discretion, patients are allowed one re-testing of A1C (to be performed in a freshly drawn sample) within 7 days of the first testing if, their basal insulin dose is ≥0.3 U/kg and if the A1C level was as low as 7.2% or as high as 11.3% and and the retested value will be used for determining eligibility.
Patients will also be allowed one A1C re-screening, if their basal insulin dose is ≥
0.3 U/kg and if their A1C level at the first screen was as low as 7.2% or as high
as 11.3%. The re-screen should be performed in ≥ 2 months after the first screen.
f)Patients who already perform SMBG and who are willing to test BG over the course of the study a minimum of 4 times per day as well as 7 times per day for 3
days during baseline and in the week prior to follow-up visit 6C (week 24) and visit 8 (week 44) (for a total of 9 days).
g) In the subset of sites that are participating in CGM: Patients who are willing to wear a CGM for one to two weeks during the baseline period and for one to two
weeks prior to follow-up visit 6C at week 24. Exclude patients who are unable or unwilling to not use acetaminophen/paracetamol for at least 4 hours prior to CGM and during CGM.
h)Negative urine β-HCG pregnancy test at screening and randomization for women
of childbearing age. Women who are capable of pregnancy and who are heterosexually active, must be practicing an effective method of birth control including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm, or cervical cap, with spermicidal foam, cream or gel) or male partner sterilization, and consistent with local regulations regarding use of birth control methods for patients participating in clinical studies, for the duration of their participation in the study. (Note: women who are not heterosexually active at screening must agree to utilize effective method of birth control if they become heterosexually active during their participation in the study).
i)Serum follicle-stimulating hormone (FSH) level for postmenopausal women consistent with postmenopausal status as per the central reference laboratory for
women with amenorrhea for at least 6 months and < 18 months before screening
(unless they are surgically sterile).
j)Body Mass Index of ≤ 40 kg/m2 (Appendix J).
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| E.4 | Principal exclusion criteria |
a. Currently on or have been treated in the past year with insulin regimens that include bolus insulins (e.g. regular insulin, rapid acting analogs, or premixed insulin) or use of Continuous Subcutaneous Insulin Infusion (CSII) (Note: this would not include the need for insulins in the settings of acute illness or hospitalization).
b. Has a history of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis.
c. Known hypersensitivity or allergy to insulin-glargine or its excipients or any other
insulins.
d. Two or more severe hypoglycemic viii episodes within the prior year. e. Hypoglycemia unawareness defined by history.
f.Patients who eat only 1 meal per day.
g. Has a history of proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy in the 6 months before screening or any other unstable (rapidly progressing) retinopathy that may
require surgical treatment (including laser photocoagulation) during the study.
h. Is currently unstable and/or has moderate-to-severe illness, in the Investigator’s judgment including (but not limited to):
1. Cardiovascular disease (including cardiac arrhythmias, myocardial infarction within last year, peripheral vascular disease); New York Heart Association (NYHA) Functional Class III or IV (Appendix K: NYHA Classification of Heart Failure);
2. Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 100 mmHg at screening.
3. Hematological disease, hematocrit outside the range of 20% to 60% at
screening, hemolytic anemia, thalassemia, sickle cell anemia, G6PD deficiency, or any known hemoglobinopathy or known abnormality that would affect measurement of hemoglobin A1C and including taking any medication known to affect red cell survival.
4. Respiratory disease.
5. Hepatic disease: including elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels (greater than 2 fold above the upper limit of normal [ULN]) and bilirubin above the normal range at
screening unless in the opinion of the Investigator and agreed upon by the medical monitor that the findings are consistent with Gilbert's disease.
6. Renal disease: including, serum creatinine > 2.0 mg/dl (176.8 µmol/l) or if currently taking Metformin ≥ 1.5 mg/dl (≥ 132.6 µmol/l) for men or
≥ 1.4 mg/dl (≥ 123.8 µmol/l) for women.
7. Gastrointestinal disease, including history of clinically significant gastroparesis.
8. Endocrine/metabolic disorders (Exception: T2DM, treated dyslipidemia,
treated hypothyroidism).
9. Thyroid stimulating hormone (TSH) > 10 µIU/ml at screening. (Note: patients on medication for hypothyroidism must be on fixed stable doses for at least 3 months prior to screening with no changes anticipated for the duration of the study).
10. Neurologic disease (including any history of seizures; stroke within the past year) or psychiatric disease, including schizophrenia, alcohol or substance abuse within the past 2 years; eating disorders. (Exception:
mood disorders or depression under control with or without stable antidepressant therapy).
11. Diagnosis and/or treatment of malignant neoplasms in the past 5 years. (Exception: adequately treated basal-cell or squamous-cell skin cancers).
12. History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period.
13. History of bariatric surgery at any time.
14. Active chronic infections (e.g., foot ulcer, HIV, etc.).
15. Any other illness that the Investigator considers should exclude the patient.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Change in A1C from baseline to week 24, comparing Finesse
versus Pen.
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
•Proportion of patients with A1C ≤ 7.0% at week 24;
•Change in percent of glucose values of CGM measurements (in a subset of patients) within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from a one or two week period of week -2 to week 0 (baseline) to a one or two week period of week 22 to week 24;
•Change in 3-day average 7-point SMBG from baseline to week 24;
•Change in 3-day coefficient of variation (CV) of 7-point
SMBG from baseline to week 24;
|
|
| 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 | Yes |
| 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 | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 7 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 30 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| 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
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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