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 MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syrén A, Umpierrez GE

Diabetes care17 Dec 2015Cited by 171 (Europe PMC)

PMID26681713DOI10.2337/dc14-2883PepBankPUB-26681713

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and moderate renal impairment, liraglutide 1.8 mg lowered HbA1c more than placebo at week 26 (estimated treatment difference -0.66%).
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, liraglutide lowered HbA1c more than placebo over 26 weeks.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change from baseline to week 26
Study
n = 279
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
HbA1c treatment difference
−0.66%
liraglutide 1.8 mg vs placebo
Source sentences
Summary
The estimated treatment difference in HbA1c from baseline to week 26 was -0.66% (-7.25 mmol/mol) (95% CI -0.90 to -0.43 [-9.82 to -4.69]), P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171301
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and moderate renal impairment, fasting plasma glucose decreased more with liraglutide than with placebo.
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, fasting blood glucose fell more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseFasting plasma glucose change
Study
n = 279
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
FPG change
−1.22 mmol/L
liraglutide
FPG change
−0.57 mmol/L
placebo
Source sentences
Summary
Fasting plasma glucose decreased more with liraglutide (-1.22 mmol/L [-22.0 mg/dL]) than with placebo (-0.57 mmol/L [-10.3 mg/dL], P = 0.036).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171302
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and moderate renal impairment, body weight fell more with liraglutide than with placebo.
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, body weight fell more with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
DecreaseBody weight change
Study
n = 279
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
Body weight change
−2.41 kg
liraglutide
Body weight change
−1.09 kg
placebo
Source sentences
Summary
There was a greater reduction in body weight with liraglutide (-2.41 kg) than with placebo (-1.09 kg, P = 0.0052).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171303
04HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and moderate renal impairment, liraglutide caused no change in renal function versus placebo (eGFR ratio to baseline -1% vs +1%).
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, liraglutide did not change kidney function compared with placebo.
Peptide
Liraglutide
Outcome
No significant changeRenal function (eGFR relative ratio to baseline)
Study
n = 279
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
eGFR relative ratio to baseline
−1%
liraglutide
eGFR relative ratio to baseline
1%
placebo
Source sentences
Summary
No changes in renal function were observed (eGFR relative ratio to baseline: -1% liraglutide, +1% placebo; estimated treatment ratio [ETR] 0.98, P = 0.36).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171304
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and moderate renal impairment, gastrointestinal adverse events were the most common adverse events: 35.7% with liraglutide versus 17.5% with placebo.
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, stomach and gut side effects were more common with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n = 279
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
GI adverse events
35.7%
liraglutide
GI adverse events
17.5%
placebo
Source sentences
Summary
The most common adverse events were gastrointestinal (GI) adverse effects (liraglutide, 35.7%; placebo, 17.5%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171305
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and moderate renal impairment, hypoglycaemic episode rates did not differ between liraglutide and placebo.
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, low blood sugar episodes were no more frequent with liraglutide than with placebo.
Peptide
Liraglutide
Outcome
No significant changeHypoglycaemic episodes
Study
n = 279
Comparator
Placebo
Outcome group
Adverse events · Metabolic and weight
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
Hypoglycaemia event rate per 100 patient-years
30.47 events
liraglutide
Hypoglycaemia event rate per 100 patient-years
40.08 events
placebo
Source sentences
Summary
No difference in hypoglycemic episodes was observed between treatment groups (event rate/100 patient-years of exposure: liraglutide, 30.47; placebo, 40.08; P = 0.54).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171306
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes and moderate renal impairment, lipase rose relative to baseline with liraglutide (ratio 1.33) but not with placebo (0.97).
In plain wordsIn adults with type 2 diabetes and moderate kidney impairment, the blood enzyme lipase rose with liraglutide but not with placebo.
Peptide
Liraglutide
Outcome
IncreaseLipase, estimated ratio to baseline
Study
n = 279
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
1.8 mg once daily · 26 weeksAs given in this study (human).
Measurements
Lipase ratio to baseline
1.33 ratio
liraglutide
Lipase ratio to baseline
0.97 ratio
placebo
Source sentences
Summary
The estimated ratio to baseline for lipase was 1.33 for liraglutide and 0.97 for placebo (ETR 1.37, P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this 26-week, double-blind trial, 279 patients with HbA1c 7-10%, BMI 20-45 kg/m(2), and moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m(2); MDRD) were randomized (1:1) to once-daily liraglutide 1.8 mg (n = 140) or placebo (n = 139).
Report a problemFND-2668171307

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT01620489

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

Novo Nordisk A/Sn = 27914 Jun 2012 to 20 Aug 2013

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 19 Mar 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 12:10 UTC
Study results updated
Version 1
9 Oct 2026, 03:05 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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