To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c (LEAD-3)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294723

NN2211-1573

Details and patient eligibility

About

This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

Enrollment: 746 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months
• Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive
• OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive
• Body Mass Index (BMI) less than or equal to 45 kg/m^2

Exclusion criteria

• Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness
• Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
• Any serious medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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746 participants in 4 patient groups

Lira 1.8

Experimental group

Description:

Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195).

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Lira 1.2

Experimental group

Description:

Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195).

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

Drug: liraglutide

Drug: liraglutide

Glimepiride - 1

Active Comparator group

Description:

Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Treatment:

Drug: placebo

Drug: glimepiride

Drug: placebo

Drug: placebo

Glimepiride - 2

Active Comparator group

Description:

Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

Treatment:

Drug: placebo

Drug: glimepiride

Drug: placebo

Drug: placebo