E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 18.1 |
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 |
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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 non-inferiority of Toujeo versus “standard of care” basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change. |
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E.2.2 | Secondary objectives of the trial |
• To demonstrate superiority of Toujeo versus “standard of care” basal insulin if non-inferiority is met, measured as HbA1c change,
• To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification,
• Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events (as defined by the American Diabetes Association Workgroup on Hypoglycemia,
• Change in fasting plasma glucose (FPG),
• Change in body weight,
• Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction
Questionnaire Status and Change Versions (DTSQs and DTSQc),
• Change in hypoglycemic control subscale (HSC),
• Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with type 2 diabetes (T2DM) insufficiently controlled (HbA1c >7%) with current (≥ 6 months) standard of care with oral agents (metformin, sulfonylurea, thiazolidinedione, dipeptidyl peptidase-4 [DPP-4] inhibitor, sodium-glucose cotransporter 2 [SGLT-2] inhibitor, glinides, alpha glucosidase inhibitors) and with or without glucagon-like peptide-1 (GLP-1) receptor agonist, and eligible to basal insulin treatment, per investigator's judgment. |
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E.4 | Principal exclusion criteria |
• HbA1c ≤7%, no upper bound,
• Age <18 years,
• Type 1 diabetes mellitus,
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study,
• Use of any product containing insulin since the time of diagnosis with T2DM other than temporary use during a pregnancy or hospitalization,
• Use of any product containing insulin occurring within 3 months prior to the time of screening,
• Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening,
.• All contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products,
• Hypersensitivity to insulin glargine or Toujeo excipients,
• Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, studycoordinator, other staff or relative thereof directly involved in the conduct of the protocol,
• Pregnancy or lactation,
• Women of childbearing potential with no effective contraceptive method. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change in HbA1c (expressed in percent) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy)
2- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not
3- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%)
4- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (blood glucose [BG] ≤ 70 mg/dl [3.9 mmol/L]) symptomatic or severe hypoglycemia
5- Proportion of patients with HbA1c target (thresholds listed above; attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia
6- Percent change in HbA1c (expressed in percent)
7- Percentage of patients whose HbA1c decreased at least 1%
8- Percentage of patients whose HbA1c decreased at least 1%
9- Percentage of patients requiring intensification and time to intensification
10- Change in fasting plasma glucose |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 4, 5 : at Month 6 and Month 12
6: Baseline to Month 12
7: at Month 6 and Month 12
8: at Month 6 and maintained at Month 12
9: at Month 6 and Month 12
10: Baseline to Month 6 and Month 12 |
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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 | No |
E.6.4 | Safety | Yes |
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 | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 156 |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 6 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 6 |