E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
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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 assess and compare the efficacy (as assessed by change from baseline in HbA1c) after 26 weeks of adding liraglutide versus sitagliptin to the pre-trial metformin treatment in subjects with type 2 diabetes inadequately controlled on metformin. |
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E.2.2 | Secondary objectives of the trial |
To assess and compare the effect of two dose levels of open label liraglutide versus open label sitagliptin after 26 weeks of treatment on other parameters of glycaemic control, ß-cell function, lipid profiles, cardiovascular biomarkers (CB), body weight, blood pressure, waist circumference and waist to hip ratio. Extension To assess the effect of two dose levels of open label liraglutide versus open label sitagliptin after 52 weeks of treatment on HbA1c and the same parameters as after 26 weeks (except CB). After 78 weeks to assess the effect of changing therapy from sitagliptin to liraglutide on HbA1c and the same parameters as after 26 weeks (except CB). To assess the sustainability of glycaemic control with liraglutide in combination with metformin over a period of 78 weeks. After all three periods of treatment: In a subset of subjects: Patient Reported Outcomes (PRO) assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject) 2.Subjects (male or female) diagnosed with type 2 diabetes 3.Stable metformin monotherapy of ≥1500 mg daily for at least three months prior to screening. Short-term change of metformin dose in connection with intercurrent illness within three months prior to enrolment into the trial is allowed, at the discretion of the Investigator 4.HbA1c 7.5-10.0% (both inclusive) 5.Age 18-80 years, both inclusive (or as allowed according to local guidelines for metformin treatment) 6.BMI ≤ 45.0 (weight [kg]/height^2 [m^2])
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E.4 | Principal exclusion criteria |
•Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator) or glucagon like peptide-1 (GLP-1) receptor agonists (including liraglutide or exenatide) or dipeptidyl peptidase 4 (DPP-4) inhibitors •Treatment with hypoglycaemic agent(s) other than metformin within the last three months prior to the trial •Impaired liver and renal function •Known clinically significant active cardiovascular disease or uncontrolled treated/untreated hypertension •Known proliferative retinopathy or maculopathy requiring acute treatment •Recurrent major hypoglycaemia or hypoglycaemic unawareness •Present or anticipated use of any drug which could interfere with glucose levels (e.g. systemic corticosteroids) •Any contraindications or other restrictions to metformin or sitagliptin according to the local labelling •Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner).” •Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the Investigator’s opinion could interfere with the results of the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
effect of changing therapy from sitagliptin to liraglutide |
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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) | Yes |
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.8.3 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 150 |
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 | Information not present in EudraCT |
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 |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 15 |