Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-6)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: exenatide; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518882

2006-006092-21 (EudraCT Number)

NN2211-1797

Details and patient eligibility

About

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

Enrollment: 467 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator
• HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%
• Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

Exclusion criteria

• Previous treatment with insulin
• Treatment with any anti-diabetic drug other than metformin and sulphonylurea
• Any previous exposure to exenatide or liraglutide
• Impaired liver or/and renal function
• History of any significant cardiac events
• Known retinopathy or maculopathy requiring acute treatment
• Recurrent major hypoglycaemia or hypoglycaemic unawareness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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467 participants in 2 patient groups

Liraglutide

Experimental group

Description:

Liraglutide 1.8 mg once daily + subject's own OAD treatment

Treatment:

Drug: liraglutide

Exenatide

Active Comparator group

Description:

Exenatide 10 mcg twice daily + subject's own OAD treatment

Treatment:

Drug: exenatide