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 SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM) also using insulin glargine |
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E.2.2 | Secondary objectives of the trial |
-To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; -To assess the relationship of anti-insulin antibodies with efficacy and safety. -To assess the efficacy of SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ≤6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. -To assess safety of SAR342434 and Humalog.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the last 6 months prior to the screening visit.
-Signed Written informed consent.
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E.4 | Principal exclusion criteria |
-At screening visit, age under legal age of adulthood. -HbA1c <6.5% or >10.0% at screening. -Diabetes other than T2DM. -Pregnancy and lactation. -Women of childbearing potential not protected by highly effective contraceptive method of birth control. -Use of insulin pump in the 6 months before screening visit. -Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an EU approved insulin lispro and is allowed in those countries where it is marketed. -Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal. -Use of non-injectable peptides (eg, GLP-1-receptor-agonists or other peptides) in the 6 months prior to screening visit. -Body mass index (BMI) ≥40kg/m² at screening visit. -Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. -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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c from baseline |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to 26 weeks |
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E.5.2 | Secondary end point(s) |
1 - Percentage of patients with HbA1c <7.0% and ≤6.5% 2 - Change in FPG from baseline 3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point Self Measured Plasma Glucose profile 4 - Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) 5 - Number of patients with hypoglycemia event 6 - Number of hypoglycemia events per patient 7 - Number of patients with injection site reactions 8 - Number of patients with hypersensitivity reactions 9 - Number of patients with adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 : at 26 weeks 2, 3 and 4: from baseline to 26 weeks 5, 6, 7, 8 and 9: up to 26 weeks |
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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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
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 |
Argentina |
Brazil |
Chile |
Colombia |
Germany |
Hungary |
Italy |
Korea, Republic of |
Mexico |
Romania |
Russian Federation |
Spain |
Turkey |
United States |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 1 |