Brief Summary

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:

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

665

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jun 2008

Typical duration for phase_3 diabetes

Geographic Reach

14 countries

163 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

2 months until next milestone

Results Posted

Study results publicly available

August 4, 2010

Completed

Last Updated

March 8, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

June 18, 2008

Results QC Date

June 11, 2010

Last Update Submit

January 25, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Week 0, Week 26
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.
Week 0, Week 52
Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78
Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.
Week 0, Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78
Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78
Week 52, Week 78

Secondary Outcomes (71)

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26
Week 0, Week 26
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52
Week 0, Week 52
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78
Week 0, Week 78
Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26
Week 0, Week 26
+66 more secondary outcomes

Study Arms (5)

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

EXPERIMENTAL

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).

Drug: liraglutideDrug: metformin

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

EXPERIMENTAL

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).

Drug: metforminDrug: liraglutide

Sita -> Sita

ACTIVE COMPARATOR

Drug: sitagliptinDrug: metformin

Sita -> Sita -> Lira 1.2 mg

EXPERIMENTAL

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.

Drug: liraglutideDrug: sitagliptinDrug: metformin

Sita -> Sita -> Lira 1.8 mg

EXPERIMENTAL

Drug: sitagliptinDrug: metforminDrug: liraglutide

Interventions

liraglutideDRUG

1.2 mg once daily, subcutaneous (under the skin) injection

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgSita -> Sita -> Lira 1.2 mg

sitagliptinDRUG

Tablets, 100 mg daily

Sita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg

metforminDRUG

Tablets, minimum 1500 mg daily

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mgLira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mgSita -> SitaSita -> Sita -> Lira 1.2 mgSita -> Sita -> Lira 1.8 mg

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.