Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: glimepiride; Drug: metformin; Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00614120

NN2211-1796

Details and patient eligibility

About

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Enrollment: 929 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
• HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
• HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
• BMI less than 45.0 kg/m^2

Exclusion criteria

• Treatment with insulin within the last 3 months prior to the trial
• Impaired liver or/and renal function
• Significant cardiovascular disease over the last 6 months
• Known retinopathy or maculopathy
• Recurrent major hypoglycaemia or hypoglycaemic unawareness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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929 participants in 4 patient groups

Lira 0.6 + Met

Experimental group

Description:

Liraglutide 0.6 mg + metformin + glimepiride placebo

Treatment:

Drug: metformin

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Lira 1.2 + Met

Experimental group

Description:

Liraglutide 1.2 mg + metformin + glimepiride placebo

Treatment:

Drug: metformin

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Lira 1.8 + Met

Experimental group

Description:

Liraglutide + metformin + glimepiride placebo

Treatment:

Drug: metformin

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Drug: placebo

Glim + Met

Experimental group

Description:

Glimepiride 4.0 mg + metformin + liraglutide placebo

Treatment:

Drug: glimepiride

Drug: metformin

Drug: placebo

Drug: placebo