E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
The primary objective of this study is to demonstrate the non-inferiority, in terms of glycemic control, of a patient-managed (nurse assisted) versus a physician-managed algorithm for titrating Insulin glargine 300U/ml (HOE901-U300) in insulin naïve type 2 diabetes mellitus (T2DM) patients inadequately controlled with oral antidiabetic agents. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to compare the two titration approaches in terms of:
• Frequency of occurrence of hypoglycemia.
• Changes in Fasting Plasma Glucose (FPG), mean 24-hour self-monitored plasma glucose (SMPG) (mmol/L; based on 7-point SMPG).
• Changes in insulin dose.
• Changes in body weight.
• Percentage of patients at glycated hemoglobin (HbA1c) target.
• Percentage of patients at HbA1c target without hypoglycemia.
• Percentage of patients at HbA1c target without hypoglycemia and weight increase.
• Patient/physician adherence to titration algorithm and correlation with glycemic control.
• Diabetes related distress.
• Diabetes Empowerment.
• Treatment satisfaction.
• Safety and tolerability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients with type 2 diabetes mellitus (for at least 1 year).
• Willingness/ability to self-manage titration algorithm.
• HbA1c ≥ 7.5 and ≤ 10.0%.
• Insulin naïve, treated with Oral Anti-Diabetics (OADs). Patients must be willing to interrupt treatment with sulfonylurea/glinides at randomization.
• Signed written informed consent |
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E.4 | Principal exclusion criteria |
• Type 1 diabetes.
• Age <18 years.
• Treated with insulin.
• Not willing to stop sulfonylurea or glinides.
• Known hypersensitivity / intolerance to insulin glargine or any of its excipients.
• Pregnant and breastfeeding women.
• Women of childbearing potential not using highly-effective birth control methods or not willing to be tested for pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the change in HbA1c from baseline to endpoint (Week 24) (delta HbA1c 0.3% non-inferiority margin). |
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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) |
The principal secondary endpoint is the incidence (%) of participants with at least one confirmed (≤3.9 mmol/L [70 mg/dL]) and/or severe nocturnal (00.00 to 05.59) hypoglycemic |
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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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
algorithm managed by physician compared to algorithm managed by patient |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 60 |
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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |