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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020193-42-GB

Enrollment

Registered

2010-06-22

Start date

2010-09-06

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type-2 Diabetes Mellitus

Interventions

Trade Name: Victoza Product Name: Victoza (Liraglutide) Product Code: Victoza (Liraglutide) Pharmaceutical Form: Injection* INN or Proposed INN: Liraglutide Other descriptive name: Victoza Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026