The effect of liraglutide compared to sitagliptin, both in combination with metformin in subjects with type 2 diabetes. A 26-week, randomised, open-label, active comparator, three-armed, parallel-group, multi-centre, multinational trial - ND

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2007-003937-17-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 651

Inclusion Criteria

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]/height2 [m2])
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous treatment with insulin, GLP-1 receptor agonists (including liraglutide or exenatide) or DPP-4 inhibitors (except for short-term treatment with insulin in connection with intercurrent illness at the discretion of the investigator). 2. Treatment with anti-diabetic drugs other than metformin within the last three months prior to the trial 3. Impaired liver function, defined as ALAT ≥ 2.5 times upper normal limit (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being the conclusive) 4. Impaired renal function defined as CrCl < 50mL/min (see section 8.3.4 for definition of Cockcroft-Gault formula), or as allowed according to local contraindications for metformin use (one retest analysed at the central laboratory within a week permitted with the result of the last sample being the conclusive) 5. Known clinically significant active cardiovascular disease, including history of unstable angina, acute coronary event, other significant cardiac events (including history of arrythmias or conduction delays on electrocardiogram (ECG)), or cerebral stroke within the past six months, and/or heart failure (New York Association (NYHA) Class IV (see appendix C), at the discretion of the Investigator 6. Known proliferative retinopathy or maculopathy requiring acute treatment, as judged by the Investigator 7. Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg) 8. 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 9. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator 10. Known or suspected allergy to trial product(s) or related products 11. Use of any drug (except for metformin), which in the Investigator?s opinion could interfere with the glucose level (e.g. systemic corticosteroids)12. Receipt of any other anti-diabetic investigational drug within three months or receipt of any investigational drug not affecting blood glucose within one month prior to screening into this trial 13. Any contraindications or other restrictions to metformin (incl. known acute or chronic acidosis or planned use of radio-contrast agents containing iodine) or sitagliptin according to the local labelling 14. Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anaesthesia, as judged by the Investigator) 15. Previous participation in the randomised phase of this trial. Re-screening is allowed once within the limits of the recruitment period 16. Known or suspected abuse of alcohol or narcotics 17. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice 18. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified