E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 evaluate the long term safety and tolerability of vildagliptin 50 mg qd versus placebo in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
Exploratory objective(s) : To explore the long term efficacy of vildagliptin 50 mg qd versus placebo in patients with T2DM and moderate or severe renal insufficiency by assessing the hemoglobin A1c (HbA1c)and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent to participate in the extension study 2. Age in the range of 18-85 years inclusive at visit 1 3. Patients with T2DM either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to visit 1) or treated with anti-diabetic therapy defined as sulfonylurea, alpha-glucosidase inhibitors (AGIs), thiazolidinediones (TZDs), insulin, and metiglinides as monotherapy or combination therapy for at least 8 weeks prior to visit 1 Patients treated with an AGI can only enter the study if their GFR is ≥30 mL/min; in addition, each country should comply with its local label for the use of AGIs in patients with renal impairment 4. Patients treated with anti-diabetic therapy must be on a stable dose for the past 4 weeks prior to visit 1 (stable insulin therapy is defined as ± 20% of total daily units) 5. GFR estimated by the Cockcroft-Gault formula < 50 mL/min at visit 1 6. HbA1c of ≥ 6.5 and ≤ 10 % at visit 1 7. Body weight < 120 kg and body mass index (BMI) 18-42 kg/m2 at visit 1
For the detailed list, see full protocol.
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E.4 | Principal exclusion criteria |
1. Premature discontinuation from the core study 2. Concomitant medical conditions that interfere with the interpretation of the study results as defined in the core protocol. 3. Failure to comply with the core study protocol per the judgment of the investigator 4. Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The variables for the primary objectives include treatment emergent adverse events (including hypoglycemia events and events of special interest) and serious adverse events. Biochemistry and hematology laboratory test results, ECG findings and vital signs/body weight will also be assessed.
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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 | No |
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) | 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 | 19 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 61 |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |