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 |
Type 2 diabetes mellitus is a situation within one's body does not use insulin well |
|
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 | 16.1 |
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 |
|
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 |
The primary objective of this study is to demonstrate that the change from baseline in mean 24 hour systolic blood pressure of LY2409021 20 mg is noninferior to placebo at 6 weeks, as measured by ABPM, in subjects with T2DM. |
|
E.2.2 | Secondary objectives of the trial |
To assess the difference between LY2409021 and placebo for additional measures of blood pressure and pulse rate and glycaemic control.
To assess the effect of LY2409021 on safety measures
To characterise the PK of LY2409021 |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic Evaluation (22-Nov-13)
Where local regulations and ERBs allow, a blood sample will be collected for pharmacogenetic analysis for genetic variants that may be related to safety and/or efficacy features of the drug. |
|
E.3 | Principal inclusion criteria |
Men and women (not of child-bearing potential) aged at least 18 years with T2DM, treated with diet and exercise alone or in combination with stable doses of MET, HbA1c greater than or equal to 6.5% and less than or equal to 8.5% (assessed by the central laboratory at screening), BPs greater than 90/60 mm Hg and less than 140/90 mm Hg, if being treated for hypertension are taking 3 or fewer antihypertensive medications and have been taking the same medication regimens for at least 1 month before screening, and with stable body weights and body mass indexes great than or equal to 20 kg/m² and less than 40kg/m² will be enrolled. |
|
E.4 | Principal exclusion criteria |
Have severe gastrointestinal (GI) disease that may significantly affect gastric emptying or motility
Previous histories or active diagnoses of pancreatitis.
Acute or chronic hepatitis, signs or symptoms of any other liver disease, or ALT level greater than 2.5 times the upper limit of normal (ULN)
Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
Mean resting PRs less than 60 bpm or greater than 100 bpm
Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in mean ABPM 24-hour SBP |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Change from baseline over 6 weeks |
|
E.5.2 | Secondary end point(s) |
Change from baseline in mean ABPM 24-hour DBP.
Mean daytime and nighttime SBP and DBP as measured by ABPM
24-hour, daytime, and nighttime peripheral PRs, pulse pressures, and MAPs, as measured by ABPM
Glycemic control (HbA1c, FBG, and 4-point SMBG profiles)
Safety measures: vital signs, TEAEs, body weight, laboratory analytes, and hypoglycemic events |
|
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 | No |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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
|
|
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 | |
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 |