NCT01512108|CompletedPhase 3Results

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN2211-3924U1111-1121-3457JapicCTI-121744

Study Type

interventional

Target

363

Locations

1 country

Sites

Timeline

RegisteredJan 2012

StartedJan 2012

CompletionApr 2013

Brief Summary

This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.

Trial Health

On Track

Trial Health Score

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

Enrollment

363

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jan 2012

Geographic Reach

1 country

36 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

1.3 years study duration

First Submitted

Initial submission to the registry

January 10, 2012

Completed

Same day until next milestone

Study Start

First participant enrolled

January 10, 2012

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

May 28, 2014

Completed

Last Updated

December 18, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

January 10, 2012

Results QC Date

April 25, 2014

Last Update Submit

November 8, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Incidence of Treatment Emergent Adverse Events (AEs)
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
Week 0 to Week 52 + 7 days

Secondary Outcomes (3)

Number of Confirmed Hypoglycaemic Episodes
Week 0 to Week 52
Change in HbA1c From Baseline to Week 52
Week 0, week 52
Change in FPG From Baseline to Week 52
Week 0, week 52

Study Arms (2)

Liraglutide + an OAD therapy

EXPERIMENTAL

Drug: liraglutide

Two OADs combination therapy

ACTIVE COMPARATOR

Drug: oral anti-diabetic drug

Interventions

liraglutideDRUG

0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).

Liraglutide + an OAD therapy

oral anti-diabetic drugDRUG

An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.

Two OADs combination therapy

Eligibility Criteria

Age20 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 would not have been performed during normal management of the subject.)
Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
HbA1c between 7.0-10.0% (both inclusive)
Body Mass Index (BMI) below 40.0 kg/m\^2
Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)

You may not qualify if:

Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
Calcitonin above or equal to 160 pg/mL
Personal history of non-familial medullary thyroid carcinoma
Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
History of chronic pancreatitis or idiopathic acute pancreatitis
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)

Contact the study team to confirm eligibility.