DelfaGLP-1 Atlas

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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

97

Recruiting sites

—

Enrollment

279

actual

Study population

Renal impairment, Type 2 diabetes

Key I/E criteria

•BMI 20-45•HbA1c 7-10%•eGFR 30-59

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Renal impairmentType 2 diabetes

Eligibility

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
8
Weight & body composition
2
Renal / kidney
2

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

GroupValue (mean), kg/m^295% 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

GroupValue (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

GroupValue (number), percentage of patients95% CI
Lira 1.8 mg46.03—
Placebo15.99—
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

GroupValue (number), percentage of patients95% CI
Lira 1.8 mg33.23—
Placebo11.23—
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

GroupValue (mean), mmol/L95% 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

GroupValue (geometric_mean), mL/min/1.73m˄295% CI
Lira 1.8 mg0.99—
Placebo1.01—
Estimated treatment ratio0.9895% CI0.94 – 1.02p= 0.3575Mixed Models Analysis
Secondary/protocol endpoint

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

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.