Effect on glycaemic control of liraglutide or exenatide added to metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes A 26-week randomised, open-label, active comparator, 2-armed, parallel-group, multi-centre, multi-national trial with a 14 week non-randomised extension period

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2006-006092-21-PL
• Date of registration: 22/05/2007
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk a/s
• Public title: Effect on glycaemic control of liraglutide or exenatide added to metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes A 26-week randomised, open-label, active comparator, 2-armed, parallel-group, multi-centre, multi-national trial with a 14 week non-randomised extension period
• Scientific title: Effect on glycaemic control of liraglutide or exenatide added to metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes A 26-week randomised, open-label, active comparator, 2-armed, parallel-group, multi-centre, multi-national trial with a 14 week non-randomised extension period
• Date of first enrolment: 14/06/2007
• Target sample size: 723
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006092-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Denmark, Finland, France, Germany, Ireland, Poland, Slovenia, Spain, Sweden

Key inclusion & exclusion criteria

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 either metformin, sulphonylurea or a combination of both, in a stable treatment regimen for at least 3 months prior to screening on maximally tolerated doses of these therapies, at the discretion of the Investigator (short-term change of metformin or sulphonylurea dose in connection with intercurrent illness within 3 months prior to screening is allowed, at the discretion of the Investigator)
3.HbA1c 7.0-11.0% (both inclusive)
4.Age 18-80 years, both inclusive (or as allowed according to local labelling for metformin, exenatide and sulphonylurea treatment)
5.Body Mass Index (BMI) = 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:
1.Previous treatment with insulin (except for short-term treatment with insulin in connection with intercurrent illness, at the discretion of the Investigator)
2.Previous treatment with exenatide
3.Treatment with oral hypoglycaemic agent(s) other than metformin or sulphonylurea in a period of 3 months prior to screening
4.Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper normal limit (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
5.Impaired renal function defined as serum-creatinine = 135 µmol/L (= 1.5 mg/dL) for males and = 115 =mol/L (= 1.3 mg/dL) for females, or as allowed according to local guidelines for metformin or sulphonylurea use (one retest analysed at the central laboratory within a week from receiving laboratory results is permitted with the result of the last sample being the conclusive)
6.Unstable angina, acute coronary event, other significant cardiac event (including history of arrhythmias or conduction delays on ECG), or cerebral stroke within the past 6 months
7.History of heart failure (NYHA class IV)
8.Known retinopathy or maculopathy requiring acute treatment as judged by the Investigator
9.Uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 100 mmHg)
10.Cancer (except basal cell skin cancer or squamous cell skin cancer) or any 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
11.Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
12.Known or suspected hypersensitivity to any components of the trial products
13.Use of any drug (except for metformin or sulphonylurea), which in the Investigator’s opinion could interfere with the glucose level (e.g. systemic corticosteroids)
14.Receipt of any other anti-diabetic investigational drug within 3 months prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 1 month prior to screening for this trial
15.Any contraindications to the relevant background treatment or to exenatide according to the local labelling
16.Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anaesthesia, as judged by the Investigator)
17.Previous participation in the randomised phase of this trial. Re-screening is allowed once within the recruitment period
18.Known or suspected abuse of alcohol or narcotics
19.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 as required by local law or practice [for Germany adequate contraceptive measures are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner]).
20.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation



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

Health Condition(s) or Problem(s) studied

type 2 diabetes
MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

Product Name: Liraglutide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: liraglutide
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.0-

Trade Name: Byetta
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Exenatide
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Trade Name: Byetta
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Exenatide
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Main Objective: To assess and compare the efficacy (as measured by HbA1c) of adding liraglutide versus exenatide in subjects with type 2 diabetes, inadequately controlled on metformin, sulphonylurea or a combination of both, after 26 weeks.

Primary end point(s): HbA1c

Secondary Objective: •To assess and compare the effect on other parameters of glycaemic control: FPG, self-measured 7-point plasma glucose profiles and fraction of subjects reaching target HbA1c of < 7.0% or = 6.5% at week 26
•To assess and compare the effect on body weight
•To assess and compare the incidence of hypoglycaemic episodes
•To assess the safety and tolerability
•To assess the formation of liraglutide and exenatide antibodies

Secondary ID(s)

2006-006092-21-SE

NN2211-1797