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

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• liraglutide — DRUG
  1.2 mg once daily, subcutaneous (under the skin) injection
• sitagliptin — DRUG
  Tablets, 100 mg daily
• metformin — DRUG
  Tablets, minimum 1500 mg daily
• liraglutide — DRUG
  1.8 mg once daily, subcutaneous (under the skin) injection

Study Details

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.

Key Dates

Start date

Jun 30, 2008

Status verified

Jan 2017

Primary completion

Jun 30, 2009

Completion

Jun 30, 2010

Study Design

Enrollment

665 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg
  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).
• Experimental: Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg
  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).
• Active Comparator: Sita -> Sita
  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).
• Experimental: Sita -> Sita -> Lira 1.2 mg
  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.
• Experimental: Sita -> Sita -> Lira 1.8 mg
  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.

Primary Outcome Measure

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26 [ Time Frame: Week 0, Week 26 ]

Locations (60)

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