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 |
Diabetes Mellitus, type 2 |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012601 |
E.1.2 | Term | 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 compare the effect of once-weekly 1.5 mg LY2189265, to that of insulin glargine (treated-to-target) on HbA1c at 26 weeks (change from baseline) in patients with type 2 diabetes who are treated in combination with prandial insulin lispro, using a non-inferiority analysis. |
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E.2.2 | Secondary objectives of the trial |
The following key secondary objectives will compare glycemic control (change from baseline) between LY2189265 (1.5 mg and 0.75 mg) and insulin glargine:
• To demonstrate that 0.75 mg LY2189265 is noninferior to insulin glargine
at 26 weeks.
• To demonstrate that 1.5 mg LY2189265 is superior to insulin glargine at
26 weeks.
• To demonstrate that 0.75 mg LY2189265 is superior to insulin glargine at
26 weeks.
See protocol for additional secondary objectives. |
|
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 |
Continuous Glucose Monitoring:
The purpose of this sub-study is to evaluate the 24-hour glucose profile for LY2189265 versus insulin glargine when either is used in combination with insulin lispro prior to meals.
The objective is to compare the 2 therapeutic interventions for percentage of time in the optimum target range for blood glucose control, to determine the percentage of time in the hyper- and hypoglycemia range, and to evaluate the glucose variability in response to therapy.
The sub-study will be offered to a subgroup of patients at selected sites. |
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E.3 | Principal inclusion criteria |
See protocol for details. |
|
E.4 | Principal exclusion criteria |
See protocol for details. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy measurement in this study is HbA1c change from baseline at 26 weeks. |
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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 from baseline to 52 weeks endpoint in glycosylated hemoglobin (HbA1c)
• Change from baseline to 26 and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose(SMBG) profiles
• Percentage of patients attaining HbA1c less than 7% and less than or equal to 6.5% at weeks 26 and 52
• Change from baseline to 26, 52 weeks, and 4 weeks after last dose for body weight
• Change from baseline to 26 and 52 weeks in total daily insulin lispro dose
• Change from baseline to 26 and 52 weeks in the EuroQoL5
• Change from baseline to 26 and 52 weeks in the Impact of Weight on Activities of Daily Living (IW-ADL)
• Change from baseline to 26 and 52 weeks in the Impact of Weight on Self-Perception (IW-SP)
• Change from baseline to 26 and 52 weeks in the Low Blood Sugar Survey (LBSS)
• Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on blood pressure
• Number of events of pancreatitis at 26 and 52 weeks, and 4 weeks after last dose
• Change from baseline to 26 and 52 weeks, and 4 weeks after last dose on pancreatic enzymes
• Change from baseline to 26 weeks and 52 weeks, and 4 weeks after last dose on serum calcitonin
• Number of self-reported hypoglycemic events at 26 weeks and 52 weeks, and 4 weeks after last dose
• Presence of LY2189265 antibodies at 26 weeks and 52 weeks and 4 weeks after last dose
• Change from baseline to 26 , 52, and 4 weeks after last dose in Body Mass Index (BMI)
• Change from baseline to 26 weeks and 52 weeks in fasting blood glucose
• Change from baseline to 26 and 52 weeks in the percentage of patients achieving HbA1c <7% without nocturnal hypoglycemia
|
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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 | 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) | 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 | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 |
Argentina |
Australia |
Belgium |
Brazil |
Canada |
Denmark |
Greece |
Hungary |
Mexico |
Poland |
Russian Federation |
South Africa |
Spain |
Sweden |
Taiwan |
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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Last Visit of Last Subject |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |