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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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. |
| 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 |
| Serial number at source | 2010-020193-42 |
| 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 |
| Lay summary | Not provided at time of registration |
| Ethics approval | The Research Ethics Committee for Wales approved on the 6th of September 2010 (ref: 10/MREC09/20) |
| Study design | Single centre open label 3 arm randomised active controlled parallel group comparative trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Type 2 Diabetes |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/08/2010 |
| Anticipated end date | 01/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | Total 66 (22 x 3 groups) |
| Interventions |
1. Group 1 Lirglutide
2. Group 2 Acarbose 3. Group 3 no intervention (standard treatment group for control) |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | West Wales Hospital Diabetes Centre (UK) - research fund |
| Trial website | |
| Publications | |
| Contact name | Dr Atir Khan |
| Address |
Diabetes Centre
West Wales Hospital |
| City/town | Carmarthen |
| Zip/Postcode | SA31 2AF |
| Country | United Kingdom |
| Tel | +44 (0)7729 691018 |
| Fax | +44 (0)1267 231339 |
| atirsultanali.khan@wales.nhs.uk | |
| Sponsor | West Wales Hospital (UK) |
| Address | Diabetes Centre |
| City/town | Carmarthen |
| Zip/Postcode | SA31 2AF |
| Country | United Kingdom |
| Tel | +44 (0)7729 691018 |
| Fax | +44 (0)1267 231339 |
| atirsultanali.khan@wales.nhs.uk | |
| Date applied | 17/08/2010 |
| Last edited | 30/08/2011 |
| Date ISRCTN assigned | 31/08/2010 |
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