E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes mellitus below 70 years of age and without a history of cardiovascular disease. |
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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 | 10045242 |
E.1.2 | Term | Type II 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 evaluate if platelet activation following a carbohydrate rich meal is related to the post-prandial hyperglycemia, and thus can be attenuated by premeal insulin treatment in patients with T2DM. |
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E.2.2 | Secondary objectives of the trial |
To elucidate if reduction of postprandial glucose levels by insulin aspart treatment reduces platelet activation and platelet-leukocyte conjugation, as assessed by other platelet-related parameters (see below), in patients with T2DM.
To elucidate if short-term lowering of blood glucose by insulin infusion (pretreatment standardization of blood glucose) reduces platelet activity in patients with T2DM.
To elucidate relationships between inflammatory activity and postprandial platelet activation and treatment effects. Possibilities of evaluating oxidative stress in a similar manner will be considered.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with T2DM below 70 years of age and with T2DM without a history of cardiovascular disease. The patients may be treated with metformin and/or insulin. Metformin treatment should be kept constant during the study. Glitazone or sulphonylurea treatment is not allowed during the study. Previous insulin treatment may be ”basal” insulin and/or meal insulin from any manufacturer.
HbA1c 7-9 % (Mono-S method).
Antecubital forearm veins allowing technically good sampling for platelet studies. |
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E.4 | Principal exclusion criteria |
Acute or chronic kidney disease (S-creatinine should be within the reference interval)
Acute or chronic liver disease (PK should be within the reference interval and ASAT and/or ALAT ≤2 times the upper reference value).
Contraindication(s) to insulin treatment.
Need for treatment with anticoagulants or acetylsalicylic acid.
Thrombocytopenia (platelet count <150 x 109/L)
Anticipated need for alteration of concomitant drug therapy during the course of the study.
Enrollment in another clinical study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Treatment effect on postprandial platelet activation. Co-primary response variables are: the thromboxane A2 analogue U46619 stimulated platelet P-selectin expression; U46619 stimulated platelet-leukocyte aggregation; circulating platelet-platelet aggregates; and circulating platelet-monocyte aggregates. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To investigate the importance of postprandial hyperglycemia for platelet activation |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | 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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When the biomedical analyses are completed and the data have been entered into the trial database. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |