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 |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 noninferiority of LY3209590 compared to insulin degludec for the treatment of T2D in adults |
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E.2.2 | Secondary objectives of the trial |
Demonstrate noninferiority of LY3209590 compared to insulin degludec for participants using, or not using GLP-1 receptor agonists, and demonstrate superiority of LY3209590 compared to insulin degludec in selected parameters of glycemic control |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must be at least 18 years of age at screening (or older per local regulations) Have a diagnosis of T2D according to the World Health Organization criteria Have an HbA1c of 7.0%-10.5%, inclusive, as determined by central laboratory at screening. To be on a stable treatment with 1 to 3 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study. Therapies must be used in accordance with the corresponding local product label. These antihyperglycemic medications are accepted in the study - DPP-4 inhibitors - SGLT2 inhibitors - biguanides, such as metformin - alpha-glucosidase inhibitors - GLP-1 receptor agonists, oral or injectable - sulfonylureas, or - thiazolidinediones To be insulin naïve |
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E.4 | Principal exclusion criteria |
Have a diagnosis of T1D, latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening Have had severe hypoglycemia episodes within 6 months prior to screening Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate <20 mL/min/1.73 m2 as calculated by the Chronic Kidney Disease-Epidemiology equation, determined by central laboratory at screening Have had a blood transfusion or severe blood loss within 90 days prior to screening. Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening - acute myocardial infarction - cerebrovascular accident (stroke), or - coronary bypass surgery
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
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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) |
- Change in HbA1c from baseline to Week 52 - Time in glucose range between 70 and 180 mg/dL, (3.9 and 10.0 mmol/L), inclusive, collected during the CGM session prior to Week 52 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 |
Brazil |
Canada |
China |
Japan |
Korea, Republic of |
Mexico |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 11 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 7 |