E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus tipo 2 Type 2 diabetes mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053247 |
E.1.2 | Term | Insulin-requiring type 2 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 assess the 24-hour weighted mean glucose (WMG)-lowering efficacy, safety and tolerability of MK-3577 |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of morning and/or evening administration of MK-3577 on fasting glucose levels, 2-hour postprandial glucose levels after the morning meal and LDL-C |
|
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 |
Hoja de Información Genética Doble Codigo Objetivo: Investigación genética futura. |
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E.3 | Principal inclusion criteria |
Patient has type 2 diabetes and is at least 18 years of age and no older than 78 years of age --Patient is male or is a female who is unlikely to conceive children --Patient is on stable doses of a PPARg agonist and metformin OR metformin and a sulfonylurea agent |
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E.4 | Principal exclusion criteria |
Patient has Type 1 diabetes --Patient has taken a DPP-4 inhibitor or a GLP-1 analogue --Patient is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening --Patient has had surgery within 30 days of screening or has major surgery planned during the study --Patient is on or is likely to require treatment with corticosteroids for more than 2 weeks --Patient has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease --Patient is HIV positive --Patient has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening --Patient has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening --Patient has severe active peripheral vascular disease --Patient has a history of cancer or blood disorder --Patient is pregnant or breast feeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: A1C Safety and tolerability: Assessed by a review of all safety parameters including adverse experiences, laboratory safety parameters, body weight, and vital signs. |
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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 | No |
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
|
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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |