E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
postprandial hyperglycaemia in type 2 diabetes |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10045242 |
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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 and compare the efficacy of three different doses of nasal GLP-1 versus placebo on glycaemic control during a day including three meals. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess and compare three doses of nasal GLP-1 versus placebo on: • Safety and tolerability (using the Gastrointestinal System Rating Scale (GRSR) on the four treatment days with three different doses. • Suppression of glucagon and free fatty acid • Beta-cell sensitivity to changes in glucose during the meal • Hypoglycaemic events
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Age between 30 and 70 years old • Type 2 diabetes in accordance to WHO • Duration of diet or diet and metformin treatment > 3 months • HbA1c > 7.5 % and < 9.0 % • Fasting blood glucose between 7 and 10 mmol/l • Stable glyceamic control and metformin dose for at least one month before randomisation • Fasting C-peptide > 0.3 nmol/l • Negative for ICA and GAD 65 • BMI between 25 and 35 kg/m2
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E.4 | Principal exclusion criteria |
• Subjects treated with the following medications during the last month: corticosteroids, hormones (except oestrogens) • Proliferative retinopathy • Known or suspected abuse of alcohol or narcotics • Subjects with hypoglycaemic unawareness • Recurrent major hypoglycaemia more than one time during the last one year. • Impaired hepatic function (ASAT or ALP > 2 times normal range) • Impaired renal function (Serum-creatinine > 150 micromol/l (1.7 mg/dl)) • Cardiac problems defined as: - Decompensated heart failure (NYHA class III or IV) - Unstable angina pectoris - Myocardial infarction within the last 12 months • Uncontrolled hypertension (systolic pressure > 180 mm Hg and/or diastolic pressure > 100 mm Hg) • Abnormal findings in the nasal cavity • Any condition that the investigator feels would interfere with trial participation. • Pregnancy, breastfeeding or intention of becoming pregnant or judge to be using an inadequate contraceptive measure. • Receiving any investigational drug within the last 3 months
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E.5 End points |
E.5.1 | Primary end point(s) |
• Changes in glucose control and in GLP-1 concentrations |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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This is described in the protocol |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |