E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type 2 |
Diabetes mellitus Typ 2 |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 Diabetes |
Typ 2 Diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 the efficacy of the GlucoTab system for glycemic management using insulin glargine U300 in non-critically ill patients with type 2 diabetes at the general ward |
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E.2.2 | Secondary objectives of the trial |
To investigate safety, usability and further efficacy parameters of the GlucoTab system using insulin glargine U300 Hypoglycemia rates Time in target (100-140mg/dl) Glucose variability as assessed by continuous glucose monitoring Insulin doses (total, basal, bolus)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent obtained after being advised of the nature of the study Male or female aged ≥18 years Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c. insulin therapy
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E.4 | Principal exclusion criteria |
• Type 1 diabetes, gestational diabetes Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient Pregnancy Any mental condition rendering the patient incapable of giving his consent Known or suspected allergy to insulin glargine or insulin glulisine Continuous parenteral nutrition Participation in another trial which can influence the software algorithm
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Lenght of GlucoTab treatment |
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E.5.2 | Secondary end point(s) |
Safety: • Number of hypoglycemic episodes requiring third party help • Number of blood glucose measurements per day • Number of missed blood glucose measurements per day • Number of additionally required blood glucose measurements • Insulin dose - basal, bolus and corrective insulin dose per day • Number of insulin injections per day • Number and reasons for non-performance of insulin injections per day • Relevant concomitant medication (corticosteroids, parenteral nutrition, oral hypoglycemic agents)
Usability: • Adherence to the insulin dose suggestion of the GlucoTab system Efficacy: • Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose • Mean pre-enrolment blood glucose • Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl. • Time of glucose measurements (CGM) in the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Length of GlucoTab treatment |
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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 | No |
E.8.1.1 | Randomised | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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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LPLV: last patient last visit |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | |