Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).

Trial Health

On Track

Trial Health Score

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

Enrollment

404

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Oct 2013

Geographic Reach

9 countries

61 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

1.1 years study duration

Study Start

First participant enrolled

October 1, 2013

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2015

Completed

Last Updated

February 9, 2017

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

October 23, 2013

Results QC Date

November 18, 2015

Last Update Submit

December 15, 2016

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Haemoglobin (HbA1c) From Baseline
Change from baseline in HbA1c after 26 weeks of treatment.
Week 0, week 26

Secondary Outcomes (6)

Change in Fasting Plasma Glucose (FPG) From Baseline
Week 0, week 26
Change in Body Weight From Baseline
Week 0, week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)
After 26 weeks of treatment
Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)
After 26 weeks of treatment
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)
After 26 weeks of treatment
+1 more secondary outcomes

Study Arms (2)

Metformin + liraglutide 1.8 mg

EXPERIMENTAL

Drug: liraglutide

Metformin + lixisenatide 20 microg

ACTIVE COMPARATOR

Drug: lixisenatide

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 s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).

Metformin + liraglutide 1.8 mg

lixisenatideDRUG

Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

Metformin + lixisenatide 20 microg

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 T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
Body Mass Index (BMI) equal to or above 20 kg/m\^2

You may not qualify if:

Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law 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 (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m\^2 per Modification of Diet in Renal Disease (MDRD) formula
Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
Heart failure, New York Heart Association (NYHA) class IV
Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Contact the study team to confirm eligibility.