A comparative study 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.
| ISRCTN | ISRCTN47355247 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47355247 |
| EudraCT/CTIS number | 2010-020193-42 |
| Secondary identifying numbers | 2010-020193-42 |
- Submission date
- 17/08/2010
- Registration date
- 31/08/2010
- Last edited
- 23/06/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Atir Khan
Scientific
Scientific
Diabetes Centre
West Wales Hospital
Carmarthen
SA31 2AF
United Kingdom
| Phone | +44 (0)7729 691018 |
|---|---|
| atirsultanali.khan@wales.nhs.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | Lirabose1 |
| Study objectives | 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(s) | The Research Ethics Committee for Wales, 06/09/2010, ref: 10/MREC09/20 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Liraglutide, acarbose |
| Primary outcome measure | 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 study start date | 01/08/2010 |
| Completion date | 01/12/2012 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Total 66 (22 x 3 groups) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/08/2010 |
| Date of final enrolment | 01/12/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
West Wales Hospital
Carmarthen
SA31 2AF
United Kingdom
SA31 2AF
United Kingdom
Sponsor information
West Wales Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Diabetes Centre
Carmarthen
SA31 2AF
Wales
United Kingdom
| Phone | +44 (0)7729 691018 |
|---|---|
| atirsultanali.khan@wales.nhs.uk | |
"ROR" |
https://ror.org/01cs14q41 |
Funders
Funder type
Hospital/treatment centre
West Wales Hospital Diabetes Centre (UK) - research fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
