Liraglutide & Acarbose effect on HbA1c, Wt and HRQOL in type2 Diabetes

• Research type

  Research Study

• Full 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 Hypoglycemic Agents (OHA's)+ high doses of insulin.

• IRAS ID

  47224

• Contact name

  Atir Khan

• Sponsor organisation

  Hywel Dda Health Board

• Eudract number

  2010-020193-42

• ISRCTN Number

  2010-020193-42

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Most patients with type-2 Diabetes require insulin in combination with oral hypoglycaemic agents. Sub-optimal glucose control increases the risk of both micro (e.g. Diabetic retinopathy) and macro-vascular complications (e.g. heart attack). However, it is a common to see in clinical practice that insulin treated type-2 Diabetic patients despite on high doses of insulin and oral hypoglycaemic agents have suboptimal control and insulin doses are gradually increased to achieve a better control. Increments in insulin doses are related to problem of weight gain. Weight gain in turn results in increase in blood pressure and increased incidence of cardiovascular problems. It is also commonly noted that these patients gradually lose their interest in the management of their Diabetes and it affects their quality of life. Depression is common in patients with Diabetes and the Zodiac-4 study published in Journal ??Diabetes Care? has concluded that quality of life is directly related to morbidity and mortality in patients with Diabetes. Despite the above, there is lack of evidence about management of type-2 Diabetic patients failing to achieve glycaemic control despite being on high doses of insulin and oral hypoglycaemic agents. The recent introduction of GLP analogues in management of type-2 Diabetes has opened new possibilities to address challenging clinical problems. In this study we would like to compare the effect of adding Liraglutide (a GLP analogue injection) OR Acarbose (an oral anti-Diabetic drug) in patients treated with high doses of insulin (at least 1 unit/kg/day) and oral anti-Diabetic agents (metformin and Gliclazide/Glimepride). The liraglutide arm and the Acarbose arm of the study will be compared with current treatment (i.e. insulin metformin gliclazide/glimepride). We will use RAND-36 quality of life questionnaire to compare the quality of life in each arm of the study at baseline and at 12 months.

• REC name

  Wales REC 3

• REC reference

  10/MRE09/20

• Date of REC Opinion

  6 Sep 2010

• REC opinion

  Further Information Favourable Opinion