Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus.

Krishnan K, Raman S, Anand Moses CR, Rajesh RP, Gupta A, Mudaliar V, Vimal J

Diabetes research and clinical practice5 Dec 2023Cited by 5 (Europe PMC)

PMID38061446DOI10.1016/j.diabres.2023.111034PepBankPUB-38061446

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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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, proposed biosimilar Levim liraglutide reduced HbA1c at week 24 (least square mean -1.09%).
In plain wordsIn adults with type 2 diabetes, the liraglutide biosimilar lowered HbA1c after 24 weeks, by a similar amount to the reference liraglutide.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change at week 24, Levim liraglutide
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Measurements
HbA1c change
−1.09%
Levim liraglutide, week 24
Source sentences
Summary
The least square mean (standard error, SE) for the primary efficacy endpoint of reduction in HbA1c% at Week 24 was -1.09 (0.15)% for Levim liraglutide group and -1.04 (0.14)% for reference liraglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144601
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, reference liraglutide reduced HbA1c at week 24 (least square mean -1.04%).
In plain wordsIn adults with type 2 diabetes, the reference liraglutide lowered HbA1c after 24 weeks, by a similar amount to the biosimilar.
Peptide
Liraglutide
Outcome
DecreaseHbA1c change at week 24, reference liraglutide
Study
n: not reported in source
Comparator
Levim liraglutide
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Measurements
HbA1c change
−1.04%
reference liraglutide, week 24
Source sentences
Summary
The least square mean (standard error, SE) for the primary efficacy endpoint of reduction in HbA1c% at Week 24 was -1.09 (0.15)% for Levim liraglutide group and -1.04 (0.14)% for reference liraglutide.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144602
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, Levim liraglutide was non-inferior to reference liraglutide for HbA1c reduction (upper bound below the 0.4% margin, P = 0.0003).
In plain wordsIn adults with type 2 diabetes, the liraglutide biosimilar was not worse than the reference liraglutide at lowering HbA1c.
Peptide
Liraglutide
Outcome
No significant changeNon-inferiority of HbA1c reduction (Levim versus reference)
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Measurements
Non-inferiority margin
0.4%
HbA1c
P-value
0.0003
non-inferiority test
Source sentences
Summary
The upper bound of the confidence interval for treatment difference was less than the non-inferiority margin of 0.4 % at one-sided alpha of 0.025 (P-value = 0.0003).
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144603
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, the proportion of patients achieving HbA1c reduction was comparable between Levim and reference liraglutide.
In plain wordsIn adults with type 2 diabetes, similar numbers of people reached an HbA1c reduction with the biosimilar and the reference liraglutide.
Peptide
Liraglutide
Outcome
No significant changeProportion achieving HbA1c reduction
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144604
05HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, glycaemic levels were comparable between Levim and reference liraglutide.
In plain wordsIn adults with type 2 diabetes, blood glucose levels were similar with the biosimilar and the reference liraglutide.
Peptide
Liraglutide
Outcome
No significant changeGlycaemic level
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144605
06HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, weight outcomes were comparable between Levim and reference liraglutide.
In plain wordsIn adults with type 2 diabetes, weight outcomes were similar with the biosimilar and the reference liraglutide.
Peptide
Liraglutide
Outcome
No significant changeWeight
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Secondary
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144606
07HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, changes in cardiovascular parameters were comparable between Levim and reference liraglutide.
In plain wordsIn adults with type 2 diabetes, changes in heart and blood vessel measures were similar with the biosimilar and the reference liraglutide.
Peptide
Liraglutide
Outcome
No significant changeCardiovascular parameters
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Secondary
Outcome group
Heart function · Cardiovascular
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144607
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, the overall safety profile of Levim liraglutide was comparable to that of reference liraglutide.
In plain wordsIn adults with type 2 diabetes, the safety profile of the biosimilar was similar to that of the reference liraglutide.
Peptide
Liraglutide
Outcome
No significant changeOverall safety profile
Study
n: not reported in source
Comparator
Reference liraglutide (Victoza)
Analysis
Secondary
Outcome group
Adverse events · Metabolic and weight
Studied dose
Dose not stated · 24 weeksAs given in this study (human).
Source sentences
Summary
The secondary endpoints for proportion of patients achieving reduction in HbA1c, glycaemic level and weight, changes in cardiovascular parameters and the overall safety profiles of the study drugs were comparable.
2 context sentences(design, population, supporting numbers)
Summary · context
Patients aged 18-65 years of age with glycosylated hemoglobin (HbA1c) between 7 and 10 %, among other criteria, were included in the study.
Summary · context
Patients were randomized 1:1 to receive daily doses of either Levim liraglutide or reference liraglutide for 24 weeks.
Report a problemFND-3806144608

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

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, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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Phase 3 efficacy and safety trial of proposed liraglutide biosimilar for reduction of glycosylated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus.

Summary

Results from this study8

Version history

Subjects

Publication types

MeSH terms

Keywords