Brief Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.

Trial Health

On Track

Trial Health Score

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

Enrollment

407

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Dec 2013

Geographic Reach

7 countries

106 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

1.5 years study duration

First Submitted

Initial submission to the registry

July 22, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed

4 months until next milestone

Study Start

First participant enrolled

December 2, 2013

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2015

Completed

1 year until next milestone

Results Posted

Study results publicly available

July 1, 2016

Completed

Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

July 22, 2013

Results QC Date

May 23, 2016

Last Update Submit

September 3, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
From baseline to week 26

Secondary Outcomes (6)

Change in Body Weight
From baseline to week 26
Change in Fasting Plasma Glucose
From baseline to week 26
Change in Fasting Blood Lipids
From baseline to week 26
Change in Systolic Blood Pressure and Diastolic Blood Pressure
From baseline to week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
After 26 weeks of treatment
+1 more secondary outcomes

Study Arms (2)

Liraglutide + metformin + sitagliptin placebo

EXPERIMENTAL

Drug: liraglutideDrug: placebo

Sitagliptin + metformin + liraglutide placebo

EXPERIMENTAL

Drug: sitagliptinDrug: placebo

Interventions

liraglutideDRUG

Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)

Liraglutide + metformin + sitagliptin placebo

sitagliptinDRUG

100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)

Sitagliptin + metformin + liraglutide placebo

placeboDRUG

Sitagliptin placebo tablets once-daily

Liraglutide + metformin + sitagliptin placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

\- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
\- Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
\- HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
\- Body mass index equal to or above 20 kg/m\^2

You may not qualify if:

\- Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
\- Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
\- History of chronic pancreatitis or idiopathic acute pancreatitis
\- Screening calcitonin value equal to or above 50 ng/L
\- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
\- Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
\- Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
\- Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m\^2 per modification of diet in renal disease formula
\- Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
\- Heart failure, New York Heart Association class IV
\- Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)

Contact the study team to confirm eligibility.