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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2005-003415-71-IT
Date of registration:	15/03/2006
Prospective Registration:	No
Primary sponsor:	NOVO NORDISK
Public title:	Liraglutide Effectand Action in Diabetes LEAD-5 Effects on glycaemic control after once daily administration of liraglutide in combination with glimepiride and metformin versus glimepiride and metformin combination therapy,and versus insulin glargine added to glimepiride and metformin combination therapy in subjects with type 2 diabetes.A six-month randomised,double-blind, parallel-group, multi-centre,multi-national trial with an open-label treat-to-target insulin glargine control arm - ND
Scientific title:	Liraglutide Effectand Action in Diabetes LEAD-5 Effects on glycaemic control after once daily administration of liraglutide in combination with glimepiride and metformin versus glimepiride and metformin combination therapy,and versus insulin glargine added to glimepiride and metformin combination therapy in subjects with type 2 diabetes.A six-month randomised,double-blind, parallel-group, multi-centre,multi-national trial with an open-label treat-to-target insulin glargine control arm - ND
Date of first enrolment:	13/02/2006
Target sample size:	1036
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003415-71
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no
Phase:

Countries of recruitment
Austria	Denmark	Finland	Italy	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
6.2 Inclusion Criteria 1. Informed consent obtained before any trial-related activities trial-related activities are any procedure 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 three months. 3. HbA1c 61485; 7.5-10.0 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 metformin and glimepiride treatment . 5. BMI 61603; 45.0 kg/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:
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 normal one retest analysed at the central laboratory within a week is permitted with the result of the last sample being the conclusive . 3. Subjects known to be Hepatitis B antigen or Hepatitis C antibody positive. 4. Impaired renal function defined as serum-creatinine 61619; 135 61549;mol/L 61619; 1.5 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 the 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 III and IV see Appendix C at the discretion of the Investigator. 6. Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator. 7. Uncontrolled treated/untreated hypertension systolic blood pressure 61619; 180 millimetre mm mercury Hg and/or diastolic blood pressure 61619; 100 mmHg . 8. Cancer except basal cell skin cancer or sqaumous 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 product s 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 intention of becoming pregnant or not using adequate contraceptive methods adequate contraceptive measures as required by local law or practice . 17. Any contraindications to metformin, glimepiride or insulin glargine according to local requirements . 6.4 Randomisation Criteria 1. Daily use of 4 mg glimepiride and 2000 mg metformin for at least 3 weeks. 2. Mean fasting plasma glucose FPG of 7.5-12.8 mmol/L both inclusive 135-230 mg/dL both inclusive measured by the Investigator at the clinic by the 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 visit window between Visit 2 and Visit 3 5 days .

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 6.1 Level: PT Classification code 10012601

Intervention(s)

Product Name: Liraglutide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
CAS Number: 204656-20-2
Current Sponsor code: NN2211
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: AMARYL 30 CPR 2 MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Glimepiride
CAS Number: 93479-97-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: GLUCOPHAGE 30 CPR RIV. 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
CAS Number: 1115-70-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: LANTUS SC 1FL 10ML 100UI/ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glargine
CAS Number: 1115-70-4
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: To assess and compare the effect on body weight To assess and compare the effect on glycaemic control fasting plasma glucose FPG and 8-point plasma glucose profiles self-measured To assess and compare cell function fasting insulin, fasting C-peptide, fasting pro-insulin and fasting glucagon. The homeostasis model assessment HOMA 1 will be used To assess and compare lipid profiles total cholesterol TC , low density lipoprotein cholesterol LDL-C , very low density lipoprotein cholesterol VLDL-C , high density lipoprotein cholesterol HDL-C , triglyceride TG , free fatty acid FFA , apolipoprotein B ApoB To assess and compare the effect on blood pressure Safety objectives To assess and compare the incidence of hypoglycaemic episodes To assess the safety and tolerability of liraglutide in combination with glimepiride and metformin To assess formation of liraglutide antibodies Other objectives To assess and compare card

Main Objective: Primary objective To assess and compare the effect on glycaemic control as measured by HbA1c of once daily administration of liraglutide in combination with glimepiride and metformin versus glimepiride and metformin combination therapy, and versus insulin glargine added to glimepiride and metformin combination therapy in subjects with type 2 diabetes.

Primary end point(s): Primary Efficacy Endpoint HbA1c

Secondary Outcome(s)

Secondary ID(s)

2005-003415-71-AT

NN2211-1697

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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