E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes diagnosed according to the criteria from WHO |
|
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 |
Assess the effects of 3 months DPP-IV inhibitor treatment (Januvia®) on meal-induced secretion and insulinotropic effect of the incretin hormones, GLP-1 and GIP, on insulin sensitivity and on the β-cell secretory capacity. |
|
E.2.2 | Secondary objectives of the trial |
Examine the effects of 3 months DPP-IV inhibitor treatment on the potential DPP-IV substrates glucagon-like peptide 2 (GLP-2) and peptide-YY, on somatostatin and a further clarification of their role in the impaired incretin effect. Examine the effects of 3 months DPP-IV inhibitor treatment on glycaemic control parameters (HbA1c and fasting plasma glucose)
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Type 2 diabetes diagnosed according to and in accordance with the WHO criteria • Metformin treatment of ≥ 1 gram • 7,0 % ≤ HbA1c ≤ 10% • Age > 18 • BMI ≥ 25 kg/m2 • Informed consent • Contraception, if appropriate
|
|
E.4 | Principal exclusion criteria |
• Proliferating retinopathy • Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria (>300 mg/day) • Liver disease with ALAT and/or ASAT > 2 x normal value • Complicated coronary artery disease, NYHA group III and IV • Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies • Occurrence of type 1 diabetes in first degree relatives • Anaemia • Pregnancy and/or breast feeding • Treatment with medication affecting insulin secretion • non-compliance
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia® treatment in patients with type 2 diabetes. The primary secondary efficacy end points are an improvement in insulin sensitivity and β-cell secretory capacity.
In part two, the primary efficacy end point is the restoration of the insulinotropic effect of GIP, measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose, after 12 weeks of Januvia® treatment.
In both part one and part two of the trial, secondary objectives will be an investigation of the treatment effect on the hormones glucagon, somatostatin and the potential DPP-IV substrates GLP-2 and peptide YY, as well as two glycaemic control parameters (HbA1c and fasting plasma glucose).
|
|
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 | No |
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) | Yes |
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 | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The trial will be closed when 24 patients in each trial part have completed 3 months of Januvia® or placebo treatment and the associated investigations. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |