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

Hywel DdA Health Borad0 sites66 target enrollmentJune 22, 2010

Overview

No summary available.

Registry

who.int

Start Date

June 22, 2010

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Hywel DdA Health Borad

•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

•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.