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 | 10067585 |
E.1.2 | Term | 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 |
1) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on A1C compared with the addition of placebo; 2) To assess the safety and tolerability of the addition of sitagliptin compared with the addition of placebo. |
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E.2.2 | Secondary objectives of the trial |
1) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on 2-hour post-meal glucose (PMG) (following a standard meal) compared with the addition of placebo; 2) After 24 weeks, to assess the effect of the addition of treatment with sitagliptin on fasting plasma glucose (FPG) compared with the addition of placebo; 3) After 24 weeks to assess the proportion of patients requiring rescue therapy with the addition of treatment with sitagliptin compared with the addition of placebo; 4) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on A1C; 5) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on 2-hour PMG; 6) After 54 weeks, to assess the effect of the addition of treatment with sitagliptin on FPG. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Visit 1 - Patient has T2DM and is ≥18 and ≤78 years of age. - Patient is a male, female who is not of reproductive potential, or patient is female of reproductive potential and agrees to remain abstinent or use an acceptable method of birth control during the study. - Patient is currently taking a stable dose for ≥10 weeks prior to Visit 1/Screening Visit of either glimepiride (≥2mg q.d.) or gliclazide (≥50% of the maximum registered dose) AND metformin (≥1500mg/day). - Patient has a Visit 1/Screening Visit site-fingerstick A1C ≥7.0% and ≤11.0%. Visit 2 - Patient has a central laboratory A1C ≥7.5% and ≤10.5%. Visit 4 - Patient has ≥85% compliance with placebo treatment during single-blind run-in period. |
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E.4 | Principal exclusion criteria |
Visit 1 - Patient has a history of type 1 diabetes mellitus, ketoacidosis, or is assessed as having type 1 diabetes. Visit 2 - Patient has ever been treatment with a DPP-4 inhibitor or a GLP-1 mimetic OR has required insulin therapy within 12 weeks of signing the informed consent. - Patient is likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. - Patient has a history of active liver disease. - Patient is HIV positive. - Patient has NYHA Class I-IV congestive heart failure, new or worsening symptoms of coronary heart disease or congestive heart failure with the past 3 months. - Patient has poorly controlled hypertension (systolic ≥160 mm Hg or diastolic ≥90 mm Hg) - Patient has active peripheral vascular disease. - Patient has history of malignancy or clinically important haematological disorder. - Patient has an exclusionary laboratory value (as listed in protocol Table 2-1). - Patient has a positive urine pregnancy test. Visit 3 - Patient has a clinically significant laboratory or ECG abnormality. Visit 4 - Patient has a positive urine pregnancy test. - Patient has a site-fasting-fingerstick glucose (FFSG) <130 mg/dL or >270 mg/dL. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A1C – change from baseline at Week 24 |
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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 | 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 | 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) | Yes |
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 | No |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 11 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 11 |