The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide; Drug: sitagliptin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00700817

2007-003937-17 (EudraCT Number)

NN2211-1860

Details and patient eligibility

About

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

1. Week 27-52 after randomisation

   • All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen.

2. Week 53-78 after randomisation

   • Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.
   • Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

Enrollment: 665 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Treatment with metformin alone for at least three months
• HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
• Body Mass Index (BMI) less than or equal to 45.0

Exclusion criteria

• Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
• Treatment with anti-diabetic drugs other than metformin within the last three months
• Any serious medical condition
• Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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665 participants in 5 patient groups

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

Experimental group

Description:

Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: metformin

Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

Experimental group

Description:

Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Treatment:

Drug: liraglutide

Drug: liraglutide

Drug: metformin

Sita -> Sita

Active Comparator group

Description:

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52).

Treatment:

Drug: sitagliptin

Drug: metformin

Sita -> Sita -> Lira 1.2 mg

Experimental group

Description:

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.

Treatment:

Drug: liraglutide

Drug: sitagliptin

Drug: liraglutide

Drug: metformin

Sita -> Sita -> Lira 1.8 mg

Experimental group

Description:

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.8 mg + metformin.

Treatment:

Drug: liraglutide

Drug: sitagliptin

Drug: liraglutide

Drug: metformin