iraglutide Effect and Action in Diabetes LEAD-1 Effect on glycaemic control after once daily administration of liraglutide in combination with glimepiride versus glimepiride monotherapy versus glimepiride and rosiglitazone combination therapy in subjects with type 2 diabetes A six-month double-blind, double-dummy, randomised, active control, parallel-group, multi-centre, multi-national trial - LEAD-1

Conditions: Diabetes Mellitus
MedDRA version: 6.1Level: PTClassification code 10012601

Registration Number: EUCTR2005-003414-15-IT

Lead Sponsor: OVO NORDISK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1865

Inclusion Criteria

6.2 Inclusion Criteria 1. Informed consent IC 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 diagnosed with type 2 diabetes and treated with OAD s for at least 3 months. 3. HbA1c 61485; 7.0-11.0 both inclusive in subjects on OAD monotherapy 61485; 7.0-10.0 both inclusive in subjects on OAD combination therapy 4. Age 18 80 years, both inclusive, as allowed according to local guidelines for glimepiride and rosiglitazone treatment . 5. Body mass index BMI 61603; 45.0 kg/m2. 6.4 Randomisation Criteria 1. Daily use of 4 mg glimepiride for at least two weeks. 2. Mean FPG of 7.0-12.8 mmol/L both incl. 126-230 mg/dL both incl. measured by the Investigator, at the clinic, by use of a glucose meter. A mean of two consecutive measurements using two strips should be used. If FPG at the day of randomisation is outside the above limits, randomisation may be postponed once within the limits of the visit window between Visit 2 and Visit 3.
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

6.3 Exclusion Criteria 1. Treatment with insulin within the last three months prior to the trial except for short-term treatment with insulin in connection with intercurrent illness at the discretion of the Investigator . 2. Impaired liver function, defined as ALAT 61619; 2.5 times upper limit of normal ULN one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive . 3. Subjects known to be Hepatitis B antigen or Hepatitis C antibody positive. 4. Impaired renal function defined as serum-creatinine 61619; 125 61549;mol/L 61619; 1.4 mg/dL for males and 61619; 110 61549;mol/L 61619; 1.3 mg/dL for females one retest analysed at the central laboratory within a week permitted with the result of the last sample being conclusive . 5. Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure New York Heart Association NYHA class I-IV at the discretion of the Investigator see Appendix C . 6. Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator. 7. Uncontrolled treated/untreated hypertension systolic blood pressure 61619; 180 mmHg and/or diastolic blood pressure 61619; 100 mmHg . 8. Cancer except basal cell skin cancer or squamous cell skin cancer or any clinically significant disease or disorder, except for conditions associated to type 2 diabetes, 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 products or related products. 11. Use of any drug except for OADs , which in the Investigator s opinion, could interfere with the glucose level e.g. systemic corticosteroids . 12. The receipt of any investigational drug within four weeks prior to this trial. 13. Previous participation in the randomised phase of this trial. Re-screening is allowed once within the limits of the recruitment period. 14. Known or suspected abuse of alcohol or narcotics. 15. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation. 16. Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods adequate contraceptive measures as required by local law or practise . 17. Any contraindications to glimepiride or rosiglitazone according to local requirements .