To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together (LEAD-2)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00318461

NN2211-1572

Details and patient eligibility

About

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Enrollment: 1,091 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
• HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
• Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion criteria

• Subjects treated with insulin within the last three months
• Subjects with any serious medical condition
• Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
• Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,091 participants in 5 patient groups

Lira 0.6 + Met

Experimental group

Description:

Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Treatment:

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: placebo

Drug: metformin

Drug: liraglutide

Lira 1.2 + Met

Experimental group

Description:

Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Treatment:

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: placebo

Drug: metformin

Drug: liraglutide

Lira 1.8 + Met

Experimental group

Description:

Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Treatment:

Drug: liraglutide

Drug: placebo

Drug: liraglutide

Drug: placebo

Drug: metformin

Drug: liraglutide

Met Mono

Active Comparator group

Description:

Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo

Treatment:

Drug: placebo

Drug: placebo

Drug: metformin

Met + Glim

Active Comparator group

Description:

Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

Treatment:

Drug: placebo

Drug: glimepiride

Drug: placebo

Drug: metformin