Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/08/2010
Date assigned
31/08/2010
Last edited
23/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes