E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type II Diabetes Mellitus |
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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 | 14.0 |
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 compare insulin glargine/ lixisenatide fixed ratio combination
versus insulin glargine on glycemic control over 24 weeks, as
evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2
diabetic patients treated with metformin |
|
E.2.2 | Secondary objectives of the trial |
To compare insulin glargine/lixisenatide fixed ratio combination
versus insulin glargine over 24 weeks on:
- Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and lucose excursions during a standardized meal test
- Percentage of patients reaching HbA1c <7% or ≤6.5%
- 7-point Self-Monitored Plasma Glucose (SMPG) profile
- Body weight
- Insulin glargine dose
- Fasting Plasma Glucose (FPG)
- Percentage of patients requiring rescue therapy during the 24-week open label treatment period
- To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient with type 2 diabetes mellitus diagnosed for at least 1 year.
- Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening |
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E.4 | Principal exclusion criteria |
- Age < legal age of adulthood
- Screening HbA1c < 7% or > 10%
- Screening FPG > 250 mg/dL (> 13.9 mmol/L)
- Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
- Type 1 diabetes mellitus
- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening
- Use of insulin within the last 6 months
- Previous use of insulin, except for episode(s) of short-term treatment (≤ 15 consecutive days) due to intercurrent illness
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) at screening
- Calcitonin ≥ 20 pg/ml (5.9 pmol/l) at screening
- Alanine Transferase (ALT)> 3ULN at screening
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g multiple endocrine neoplasia syndromes)
- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively
- Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures
- Body Mass Index (BMI) ≤ 20 or > 40 kg/m²
- Any previous treatment with lixisenatide |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
- Change in post-prandial glucose during meal test
- Change in blood excursion during meal test
- Percentage of patients reaching HbA1c ≤6.5 % or <7 %
- Change in 7-point SMPG profiles
- Change in body weight
- Insulin glargine dose
- Change in FPG
- Percentage of patients requiring rescue therapy during the 24-week openlabel treatment period |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Change in post-prandial glucose during meal test, Change in blood excursion during meal test, Change in 7-point SMPG profiles, Change in body weight, Change in FPG : from baseline to week 24
- Percentage of patients reaching HbA1c ≤6.5 % or <7 %, Insulin glargine dose : at week 24
- Percentage of patients requiring rescue therapy during the 24-week openlabel treatment period : over the 24-week treatment
period |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 47 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Chile |
Mexico |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |