CompletedPhase 3Results posted

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

279

Study population

Renal impairment, Type 2 diabetes

Eligibility highlights

•BMI 20-45•HbA1c 7-10%•eGFR 30-59

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01620489

Org study IDNN2211-3916

Secondary ID2011-002968-24

Secondary IDU1111-1122-3303WHO

Timeline

Milestones

Study start2012-06-14actual

Study first posted2012-06-15estimated

Primary completion2013-08-20actual

Study completion2013-08-20actual

Results first posted2014-10-30estimated

Last update posted2019-03-19actual

Assets

Investigational agents

Liraglutide

Who this study enrolls

Renal impairmentType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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)

Exclusion criteria

•Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator

•Treatment with antidiabetic medication(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Previous short-term (below or equal to 7 days in total) treatment with rapid-or short-acting insulin in connection with intercurrent illness is allowed at the discretion of 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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Renal / kidney

Weight & body composition

2 endpoints

Secondary/registry result

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)

Time frame:Week 0, week 26

BMI, change

change from baseline, improvement

Posted result

Group	Mean · kg/m^2	95% CI
Lira 1.8 mg	-0.88	-
Placebo	-0.38	-

Estimated treatment difference-0.5195% CI-0.83 - -0.18p= 0.0022Mixed Models Analysis

Secondary/protocol endpoint

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)

Time frame:Week 0, week 26

BMI, change

change from baseline, improvement

Glycemic / diabetes

8 endpoints

Primary/registry result

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · percentage (%)	95% CI
Lira 1.8 mg	-1.05	-
Placebo	-0.38	-

Estimated treatment difference-0.6695% CI-0.90 - -0.43p<0.0001Mixed Models Analysis

Primary/protocol endpoint

Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Number · percentage of patients	95% CI
Lira 1.8 mg	46.03	-
Placebo	15.99	-

Estimated odds ratio4.4895% CI2.46 - 8.18p<0.0001Regression, Logistic

Secondary/registry result

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Number · percentage of patients	95% CI
Lira 1.8 mg	33.23	-
Placebo	11.23	-

Estimated odds ratio3.9495% CI2.12 - 7.30p<0.0001Regression, Logistic

Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.

Secondary/registry result

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

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Mean · mmol/L	95% CI
Lira 1.8 mg	-1.59	-
Placebo	-0.51	-

Estimated treatment difference-1.0895% CI-1.58 - -0.58p<0.0001Mixed Models Analysis

Secondary/protocol endpoint

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment

Time frame:At week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Renal / kidney

2 endpoints

Secondary/registry result

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)

Time frame:Week 0, week 26

eGFR, change

ratio, improvement

Posted result

Group	Geometric mean · mL/min/1.73m˄2	95% CI
Lira 1.8 mg	0.99	-
Placebo	1.01	-

Estimated treatment ratio0.9895% CI0.94 - 1.02p= 0.3575Mixed Models Analysis

Secondary/protocol endpoint

Time frame:Week 0, week 26

eGFR, change

ratio, improvement

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
The Cochrane database of systematic reviews2025 Feb 18PMID39963952doi:10.1002/14651858.CD015849.pub2via clinicaltrials gov reference derived + pubmed nct search
Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment.
Diabetes, obesity & metabolism2019 May (month)PMID30663196doi:10.1111/dom.13638via CT.gov reference
Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes.
Clinical therapeutics2018 May (month)PMID29729957doi:10.1016/j.clinthera.2018.04.002via clinicaltrials gov reference derived + pubmed nct search
Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial.
Diabetes care2016 Feb (month)PMID26681713doi:10.2337/dc14-2883via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.