E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nutritional and metabolic diseases |
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E.1.1.1 | Medical condition in easily understood language |
Patients with Type 2 Diabetes |
|
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 | 21.1 |
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 |
|
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 effect of Suliqua® once-daily on glycemic control as evaluated by Continuous Glucose Monitoring (CGM) in participants with T2DM uncontrolled on their previous basal insulin |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of Suliqua® on
• glycemic variability and postprandial glucose excursions
• the achievement of glycemic targets with a low risk of hypoglycemia and side effects
• the improvement of treatment satisfaction of participants |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants with type 2 diabetes mellitus diagnosed at least 3 years before screening visit
- Basal insulin treatment for at least 6 months
- Metformin with or without another Oral Antihyperglycemic Drug (OAD) both at stable dose for at least 3 months
- HbA1c at screening visit ≥7.5% or ≤10% |
|
E.4 | Principal exclusion criteria |
- BMI ≤20 or >40 kg/m²
- History of Type 1 Diabetes mellitus
- Any contraindication that excludes the administration of lixisenatide or insulin glargine
- History of discontinuation of a previous treatment with a GLP-1 RA for safety/tolerability reasons or lack of efficacy
- Current Glucocorticoid therapy; comorbidity with expected intermittent Glucocorticoid therapy during next 18 weeks |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in time in glucose range:
Mean change in percentage of time (%) in the target glucose range (TIR: 3,9–10 mmol/L; 70–180 mg/dL) from baseline, as measured by using CGM during the last week of an initial 18-week treatment period with Suliqua®. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Last week of an initial 18-week treatment period |
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E.5.2 | Secondary end point(s) |
1) Mean % of time in target glucose range of 3.9 to 10 mmol/L (70 to 180 mg/dL), as measured by using CGM during the last week of an initial 18-week treatment period with Suliqua®.
2) Mean change in % of time in the hyperglycemia range target with glucose > 10 mmol/L (> 180 mg/dL) and > 13.9 mmol/L( > 250mg/dL) from baseline to Week 18, as measured by CGM
3) Mean change in glucose SD from baseline to week 18 as measured by CGM
4) Mean change in glucose CV from baseline to week 18 as measured by CGM
5) Mean change in MAGE from baseline to week 18 as measured by CGM
6) Mean change in HbA1C from baseline to week 18
7) % of participants with HbA1C < 7.5%, < 7%,≤ 6,5%
8) Mean change in FPG from baseline to week 18
9) Mean change in body weight from baseline to week 18
10) Mean change in DTSQ score from baseline to week 18
11) Number of participants with at least one symptomatic hypoglycemic event
12) Number of participants with Adverse Events |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
All: from Baseline to Week 18, except of 1st and 7th points.
1st: Last week of an initial 18-week treatment period
7th: at Week 18 |
|
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
|
|
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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |