Contact information
Type
Scientific
Primary contact
Dr Atir Khan
ORCID ID
Contact details
Diabetes Centre
West Wales Hospital
Carmarthen
SA31 2AF
United Kingdom
+44 (0)7729 691018
atirsultanali.khan@wales.nhs.uk
Additional identifiers
EudraCT number
2010-020193-42
ClinicalTrials.gov number
Protocol/serial number
2010-020193-42
Study information
Scientific title
An open label, randomised controlled trial of the effects of Liraglutide and Acarbose on glycaemic control, weight and Health Related Quality Of Life (HRQOL) in Overweight type 2 Diabetic patients on Oral Hypoglycaemic Agents (OHAs) and high doses of insulin
Acronym
Lirabose1
Study hypothesis
To evaluate the effectiveness of Liraglutide Versus Acarbose and standard treatment in type-2 Diabetic patients failing to achieve glycemic control on high dose insulin and oral hypoglcemic agents
Ethics approval
The Research Ethics Committee for Wales, 06/09/2010, ref: 10/MREC09/20
Study design
Single-centre open-label three-arm randomised active-controlled parallel-group comparative trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Type 2 diabetes
Intervention
1. Group 1 Lirglutide
2. Group 2 Acarbose
3. Group 3 no intervention (standard treatment group for control)
Updated 23/06/2015: This trial has been discontinued due to poor recruitment.
Intervention type
Drug
Phase
Phase IV
Drug names
Liraglutide, acarbose
Primary outcome measures
1. Improvement in glycaemic control (assessed by measurement of HbA1c) as a result of addition of Liraglutide (a GLP analogue) or Acarbose (an oral anti-Diabetic drug), when compared with standard treatment.
Secondary outcome measures
Improvement in:
1. Weight
2. Health related quality of life, assessed by RAND-36 questionnaire at baseline and 52 weeks
3. Blood pressure
4. Total daily insulin dose
5. Hypoglycaemic episodes
Overall trial start date
01/08/2010
Overall trial end date
01/12/2012
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. Age > 18 years
2. Male or female
In addition, patients should fulfil all the following criteria at the randomization visit (visit 0):
3. Type II Diabetic patients with suboptimal glycaemic control despite on high doses (1 unit/kg/day OR 100units/day) of insulin
4. Glycated Haemoglobin (HbA1c) ≥ 7.5%
5. Body Mass Index (BMI) ≥ 29
6. On, at least: Metformin ( ≥ 1.5G/day) and Sulfonylureas (SU) (Gliclazide ≥ 240mg/day or Glimepride ≥ 4mg/day)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total 66 (22 x 3 groups)
Participant exclusion criteria
1. Previous history of: Myocardial infarction (MI) (in last 12 months)
2. Congestive Cardiac Failure (New York Heart Association [NYHA] class III or IV)
3. Stage II, III & IV Chronic kidney disease
4. Abnormal Alanine Aminotransferase (ALT) (> 3fold Upper Limit of Normal [ULN] at baseline)
5. Hypoglycaemia unawareness OR recurrent hypos requiring 3rd party assistance
6. Uncontrolled Hypertension (Blood Pressure [BP] > 180/100mmHg)
7. Pregnant OR likelihood of pregnancy during the study
8. Patients currently on OR treated in the last 12-months with a glitazone, Dipeptidyl Peptidase IV (DPP-IV), Glucagon-Like Peptide (GLP) analogue, acarbose or steroids
9. History of inflammatory bowel disease, colonic ulceration, previous abdominal surgery, history or presence of intestinal obstruction / hernia
10. Predisposition to intestinal obstruction
11. History of Diabetic ketoacidosis, gasteroparesis and pancreatitis
12. Females lactating or breastfeeding
13. History of allergic reaction or hypersensitivity to Liraglutide, Acarbose or insulin
14. Age more than 75 years
15. Type-1 Diabetes mellitus
16. History of thyroid cancer
17. Patients currently on Warfarin
18. Patients on sulphonylureas other than Gliclazide or Glimepride
Recruitment start date
01/08/2010
Recruitment end date
01/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Wales Hospital
Carmarthen
SA31 2AF
United Kingdom
Sponsor information
Organisation
West Wales Hospital (UK)
Sponsor details
Diabetes Centre
Carmarthen
SA31 2AF
United Kingdom
+44 (0)7729 691018
atirsultanali.khan@wales.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
West Wales Hospital Diabetes Centre (UK) - research fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary