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.

Phase 4

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN47355247
• Lead Sponsor: West Wales Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified