Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment. The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

Trial Health

On Track

Trial Health Score

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

Enrollment

279

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jun 2012

Geographic Reach

6 countries

97 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

June 13, 2012

Completed

1 day until next milestone

Study Start

First participant enrolled

June 14, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2013

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 30, 2014

Completed

Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

June 13, 2012

Results QC Date

August 20, 2014

Last Update Submit

March 6, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.
Week 0, Week 26

Secondary Outcomes (5)

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
At week 26
Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment
At week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles
Week 0, week 26
Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)
Week 0, week 26
Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)
Week 0, week 26

Study Arms (2)

Lira 1.8 mg

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Lira 1.8 mg

placeboDRUG

Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.

Placebo

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects diagnosed with type 2 diabetes with stable diabetes treatment (unchanged medication and unchanged dose) for 90 days prior to the screening visit including: Monotherapy or any duo-combinations of metformin and/or SUs and/or pioglitazone. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Or Monotherapy or any combinations of metformin and/or pioglitazone and/or basal or premix insulin. Insulin adjustments (total daily dose) below or equal to 10% within 90 days prior to the screening visit as confirmed by the investigator are acceptable. Metformin should be used with caution in subjects with moderate renal failure and must be used in accordance with local metformin labelling or guidelines. Combination of pioglitazone and insulin should be used with caution and according to local labelling or guidelines
HbA1c 7-10% (both inclusive)
Moderate renal impairment diagnosed more than 90 days prior to the screening visit and confirmed by an eGFR (glomerular filtration rate) of 30-59 mL/min/1.73 m2 per MDRD (modification of diet in renal disease) formula at the screening visit
Body Mass Index (BMI) 20-45 kg/m\^2 (both inclusive)

You may not qualify if:

Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal limit
History of chronic pancreatitis or idiopathic acute pancreatitis
Within the past 180 days any of the following: Episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event (including e.g. arrhythmias or conduction delays on ECG (electrocardiogram))
Heart failure defined as New York Heart Association (NYHA) class IV
A systolic blood pressure above or equal to 180 mmHg or a diastolic blood pressure above or equal to 100 mmHg
Rapidly progressing renal disease (e.g., acute glomerulonephritis) at the discretion of the investigator
Use of immunosuppressive treatment within 90 days prior to screening
Diagnosis or treatment for cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator

Contact the study team to confirm eligibility.