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 Hypoglycemic Agents (OHA's)+ high doses of insulin. - Liraglutide & Acarbose effect on HbA1c, Wt and HRQOL in type2 Diabetes

Phase 1

• Conditions: Type-2 Diabetes Mellitus

• Registration Number: EUCTR2010-020193-42-GB
• Lead Sponsor: Hywel DdA Health Borad

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-22
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Age > 18 years. Male or Female. In addition, patients should fulfil all the following criteria at the randomization visit (visit 0):
1.Type – 2 Diabetic patients with suboptimal glycaemic control despite on high doses (1 unit/kg/day OR 100units/day) of insulin.
2.(HbA1c = 7.5%).
3.BMI = 29
4.On, at least: Metformin (= 1.5G/day) + SU (Gliclazide = 240mg/day or Glimepride = 4mg/day).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous H/O: M.I. (in last 12months),
Congestive Cardiac Failure (NYHA class III or IV),
Stage II, III & IV Chronic kidney disease,
Abnormal ALT (> 3fold at baseline).
Hypoglycaemia unawareness OR recurrent hypos requiring 3rd party assistance.
Uncontrolled Hypertension (BP > 180/100mmHg).
Pregnant OR likelihood of pregnancy during the study.
Patients currently on OR treated in the last 12-months with a glitazone, DPP-IV, GLP analogue, Acarbose, steroides.
History of inflammatory bowel disease, previous abdominal surgery, history or presence of intestinal obstruction / Hernia.
History of Diabetic ketoacidosis, gasteroparesis and pancreatitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improvement in glycaemic control (measured by HbA1c) as result of addition of Liraglutide (a GLP analogue) or Acarbose (an oral anti-Diabetic drug) when compared with standard treatment.;Secondary Objective: Improvement in weight, health related quality of life, blood pressure and hypoglycaemic episodes.;Primary end point(s): 1% change in HbA1c at 52 weeks from baseline.