Brief Summary

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

303

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Mar 2017

Geographic Reach

7 countries

82 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

1.2 years study duration

First Submitted

Initial submission to the registry

November 11, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed

4 months until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed

4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 10, 2019

Completed

Last Updated

November 17, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

November 11, 2016

Results QC Date

May 7, 2019

Last Update Submit

October 26, 2020

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) to week 26 in glycosylated haemoglobin was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication" observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications.
Week 0, Week 26

Secondary Outcomes (25)

Change in Body Weight
Week 0, Week 26
Change in Fasting Plasma Glucose
Week 0, Week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target
Week 26
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target
Week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.
Week 26
+20 more secondary outcomes

Study Arms (2)

liraglutide + SGLT2i ± metformin

EXPERIMENTAL

Drug: liraglutide

liraglutide placebo + SGLT2i ± metformin

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

liraglutide + SGLT2i ± metformin

placeboDRUG

Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

liraglutide placebo + SGLT2i ± metformin

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.
Male or female, age 18 years or older at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus.
HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label.
Body mass index of 20 kg/m\^2 or above.

You may not qualify if:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 60 mL/min/1.73m\^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.
Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.
History or presence of pancreatitis (acute or chronic).
Impaired liver function, defined as ALT 2.5 or more times upper normal limit at screening.
Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

Contact the study team to confirm eligibility.