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 diabetesA six-month double-blind, double-dummy, randomised, active control, parallel-group, multi-centre, multi-national trial

Conditions: Diabetes Mellitus
MedDRA version: 8,0Level: PTClassification code 10012601

Registration Number: EUCTR2005-003414-15-CZ

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1865

Inclusion Criteria

•Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least 3 months
• HbA1c:
? 7.0-11.0 % (both inclusive) in subjects on OAD monotherapy
? 7.0-10.0 % (both inclusive) in subjects on OAD combination therapy
• Age 18-80 years, both inclusive. (as allowed according to local guidelines for glimepiride treatment)
• Body mass index (BMI) = 45.0 kilogram (kg)/square metre (m2)

At Randomisation:
• Daily use of 4 mg glimepiride for at least 2 weeks
• Mean fasting plasma glucose (FPG) of 7.0-12.8 mmol/L both incl. (126-230 mg/dL both inclusive.)

Are the trial subjects under 18?
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

• 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)
• Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (ULN) (one retest analysed at the central laboratory within a week is permitted with the last sample being the conclusive sample)
• Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females (one retest analysed at the central laboratory within a week permitted with the last sample being the conclusive sample)
• 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)
• Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
• Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
• Use of any drug (except for OADs), which, in the Investigator’s opinion, could interfere with the glucose level (e.g. systemic corticosteroids)

• 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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To assess and compare the effect on glycaemic control (HbA1c) of once daily administration of three doses of liraglutide in combination with glimepiride versus glimepiride monotherapy versus rosiglitazone and glimepiride combination therapy in subjects with type 2 diabetes;Secondary Objective: •To assess and compare the effect on body weight<br>•To assess and compare the effect on glycaemic control <br>•To assess and compare ß-cell function <br>•To assess and compare fasting lipid profiles <br>•To assess and compare the effect on blood pressure<br><br>Safety objectives<br>•To assess and compare the incidence of hypoglycaemic episodes<br>•To assess the safety and tolerability of liraglutide in combination with glimepiride<br>•To assess formation of liraglutide antibodies<br><br>Other objectives<br>•To assess and compare parameters for cardiovascular effects <br>•To assess and compare waist and hip circumference and waist-to-hip ratio;Primary end point(s): •HbA1c <br><br><br>

Secondary Outcome Measures