Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01620489Other idNN2211-3916Other id2011-002968-24Other idU1111-1122-3303

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 279 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 6 countries
United States, France, Poland, Russia, Ukraine, United Kingdom
Start: 14 Jun 2012
Primary completion: 20 Aug 2013
Completion: 20 Aug 2013
First posted: 15 Jun 2012 (estimated)
Last update posted: 19 Mar 2019
Conditions: Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201220132014

Ph 3
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
NCT01620489
14 Jun 2012 to 20 Aug 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

liraglutideDrug
placeboDrug

Arms2

Experimental
Lira 1.8 mg
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.

Secondary outcomes(5)

Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment
Time frame · At week 26
Registry description
Calculated as estimated percentage of subjects achieving HbA1c \<7.0% and no weight gain after 26 weeks of treatment based on the statistical model.
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
Registry description
Calculated as estimated percentage of subjects achieving HbA1c \<7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.
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
Registry description
SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.
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
Registry description
Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.
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
Registry description
Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, Week 26

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

Group	Value (percentage (%))	Spread
Lira 1.8 mg	-1.05	0.8944
Placebo	-0.38	0.8797

Secondary and other outcome results(5)

Secondary outcomeNumber· At week 26

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

Group	Value (percentage of patients)
Lira 1.8 mg	46.03
Placebo	15.99

Secondary outcomeNumber· At week 26

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

Group	Value (percentage of patients)
Lira 1.8 mg	33.23
Placebo	11.23

Secondary outcomeMean· Week 0, 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

Group	Value (mmol/L)	Spread
Lira 1.8 mg	-1.59	2.480
Placebo	-0.51	2.391

Secondary outcomeMean· 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)

Group	Value (kg/m^2)	Spread
Lira 1.8 mg	-0.88	1.3214
Placebo	-0.38	1.1679

Secondary outcomeGeometric mean· 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)

Group	Value (mL/min/1.73m˄2)	Spread
Lira 1.8 mg	0.99	0.17
Placebo	1.01	0.19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lira 1.8 mgSubjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).	–	14 / 140	73 / 140
PlaceboSubjects received s.c placebo 1.8 mg once daily, applying a 3-4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject's stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).	–	15 / 137	49 / 137

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Source link See results (15)

Indexing hint: Randomized controlled trial · 2019

3 results

Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment.

Zobel et al. 2019Diabetes, obesity & metabolismcited by 11

PMID 30663196PMC6593738DOI 10.1111/dom.13638PUB-30663196

Free to read · publisher termsCC BY-NC3 results

Read at source See results (3)

Indexing hint: Randomized controlled trial · 2016

7 results

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.

Davies et al. 2016Diabetes carecited by 171

PMID 26681713DOI 10.2337/dc14-2883PUB-26681713

Rights unknown7 results

Source link See results (7)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedKim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. 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. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3. PMID 29729957

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.