E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes |
Type 2 diabetes |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Type 2 diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• History of type 2 diabetes for at least 6 months • Age 18 – 90 years • Pre-meal plasma glucose in the range 10 – 22,2 mmol/L prior to inclusion • Expected hospital stay longer than 4 days (after inclusion into the trial) • Signed informed consent
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E.4 | Principal exclusion criteria |
• Hyperglycemia without known history of type 2 diabetes • Type 1 diabetes mellitus • Severely impaired renal function (eGFR ≤ 30 mL/min/1,73 m2) • Severe hepatic disease • Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months • Pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year) • Planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12 hours • Treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding) • Treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (≥ 25 mg) • History or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years • Presence of alcohol or drug abuse • Inability to understand the written information or incapability to provide informed consent • Known or suspected hypersensitivity to trial product(s) or related products. • Other concomitant medical or psychological conditions that according to the investigator´s assessment makes the patient unsuitable for study participation • Previous participation in this trial
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in mean daily plasma glucose between the two groups, calculated by using the four daily pre-meal and bedside PG values per patient. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Mean number and rates of hypoglycemic events (PG ≤ 3.9 mmol/L) per patient during hospital stay, based on bedside PG measures. • Mean number and rates of hypoglycemic events during hospital stay based on Continuous glucose monitor (CGM) data • Number of bedside PG values during hospital stay in o glucose target range (PG 5.0 - 10.0 mmol/L) o hypoglycemic ranges (PG ≤ 3.9 mmol/L and PG ≤ 2.8 mmol/L) o hyperglycemic range (PG > 10.1 mmol/L) • Percentage of time spent in the hypoglycemic range ≤ 3.9 mmol/l and ≤ 2.8 mmol/L during hospital stay (based on CGM data). • Percentage of time spent in the glycemic range between 4.0-8.0 mmol/l and time spent in range 4.0-10 mmol/l during hospital stay (based on CGM data). • Percentage of time spent in the hyperglycemic range above 8.0 mmol/l and above 10.0 mmol/l during hospital stay (based on CGM data). • Length of hospital stay • Difference in insulin dose between groups • Number of hospital acquired infections during admission • Number of post-discharge infections or re-admissions 1 month after discharge
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned days | |