E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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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 examine the efficacy of LY2409021 administered once-daily as monotherapy or in combination with metformin by comparing against placebo the mean change in HbA1c from baseline to the end of the 24-week active treatment period. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of oral doses of LY2409021 given once-daily for 24 weeks To evaluate and compare the effects of LY2409021 and placebo on blood glucose, insulin, glucagon, and glucagon-like peptide 1 (GLP-1) and safety parameters. To characterize the population pharmacokinetic and pharmacodynamic properties of LY2409021 and exploration of covariate correlations. To evaluate and compare the effect of LY2409021 and placebo on pancreatic islet beta-cell function To investigate and compare the effects of LY2409021 and placebo on markers of insulin sensitivity To evaluate and compare the effects of LY2409021 and placebo on blood lipids To evaluate if clinical and serum biomarkers are predictive of the efficacy and safety of LY2409021. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patients not of child-bearing potential with type 2 diabetes mellitus (T2DM) between 18 and 70 years old, inclusive, treated with diet and exercise alone or in combination with metformin (at least 1000 mg/day stable and unchanged for at least 3 months prior to screening) are eligible for this study. HbA1c value between 7.0% and 10.5%, inclusive and body mass index (BMI) between 25 to 45 kg/m2, inclusive. |
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E.4 | Principal exclusion criteria |
Clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening
Current or previous diagnosis of Gilbert’s disease
Nonfasting triglycerides >600 mg/dL
Use of insulin or GLP-1 agonist for more than 5 days within the 3-month period prior to screening, or any oral antihyperglycemic medication other than metformin within the 3-month period prior to screening
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline of HbA1c. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 | Information not present in EudraCT |
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 |
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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
|
The trial will end at the last visit of the last subject in 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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |