[Cortexin in the comprehensive treatment of neurological complications of type 2 diabetes mellitus. (Results of the DIACORT multicenter randomized clinical trial)].

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Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova1 Jan 2026

PMID42133422DOI10.17116/jnevro2026126041101PepBankPUB-42133422

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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, cognitive symptoms regressed more with adjunctive Cortexin than with comprehensive treatment alone.
In plain wordsIn patients with diabetes complications, cognitive symptoms decreased more with added Cortexin than with comprehensive treatment alone.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseCognitive symptom regression
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
Cognitive symptom regression
6 fold
Cortexin group
Cognitive symptom regression
1.7 fold
control group
Source sentences
Summary
The regression of cognitive symptoms in group 1 patients was superior to that in group 2 (6.0 times vs. 1.7 times), as confirmed by a 1.2-fold increase in the average MoCA score after 3 months of follow-up (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342201
02HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, anxiety scores decreased with adjunctive Cortexin, with minimal changes in controls.
In plain wordsIn patients with diabetes complications, anxiety scores decreased with added Cortexin, with minimal changes in controls.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseHADS anxiety score
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
HADS anxiety decrease
1.6 fold
Cortexin group
Source sentences
Summary
In the Cortexin group, the mean HADS anxiety score decreased by 1.6 times, and the mean depression score decreased by 1.7 times, with minimal changes noted in the control group (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342203
03HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, depression scores decreased with adjunctive Cortexin, with minimal changes in controls.
In plain wordsIn patients with diabetes complications, depression scores decreased with added Cortexin, with minimal changes in controls.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseHADS depression score
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Anxiety and mood · Mental health and mood
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
HADS depression decrease
1.7 fold
Cortexin group
Source sentences
Summary
In the Cortexin group, the mean HADS anxiety score decreased by 1.6 times, and the mean depression score decreased by 1.7 times, with minimal changes noted in the control group (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342204
04HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, numbness decreased more with adjunctive Cortexin than with comprehensive treatment alone.
In plain wordsIn patients with diabetes complications, numbness decreased more with added Cortexin than with comprehensive treatment alone.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseNumbness
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Pain · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
Numbness decrease
2.2 fold
Cortexin group
Numbness decrease
1.3 fold
control group
Source sentences
Summary
Significant reductions in numbness were observed, with a 2.2-fold decrease in the Cortexin group compared to a 1.3-fold decrease in the control group.
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342205
05HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, NTSS-9 scores decreased more with adjunctive Cortexin than with comprehensive treatment alone.
In plain wordsIn patients with diabetes complications, nerve symptom scores decreased more with added Cortexin than with comprehensive treatment alone.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseNTSS-9 score
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Pain · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
NTSS-9 decrease
2.8 fold
Cortexin group
NTSS-9 decrease
1.3 fold
control group
Source sentences
Summary
The mean NTSS-9 score dropped by 2.8 times in group 1 and by 1.3 times in group 2 (p<0.001); while the CSI decreased 1.8 times and 1.2 times, respectively (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342206
06HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, CSI scores decreased more with adjunctive Cortexin than with comprehensive treatment alone.
In plain wordsIn patients with diabetes complications, CSI scores decreased more with added Cortexin than with comprehensive treatment alone.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseCentral Sensitization Index
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Pain · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
CSI decrease
1.8 fold
Cortexin group
CSI decrease
1.2 fold
control group
Source sentences
Summary
The mean NTSS-9 score dropped by 2.8 times in group 1 and by 1.3 times in group 2 (p<0.001); while the CSI decreased 1.8 times and 1.2 times, respectively (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342207
07HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, HbA1c decreased more with adjunctive Cortexin than with comprehensive treatment alone.
In plain wordsIn patients with diabetes complications, HbA1c decreased more with added Cortexin than with comprehensive treatment alone.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
DecreaseHbA1c
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Glycemic control · Metabolic and weight
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
HbA1c
7.3%
Cortexin group
HbA1c
7.8%
control group
Source sentences
Summary
The reduction in HbA1c was also more significant in the Cortexin group (7.3±0.1% vs 7.8±0.1%, p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342208
08HumanRandomized controlled trialSafety outcome
In patients with neurological complications of diabetes, three adverse events occurred with adjunctive Cortexin and two with comprehensive treatment alone; none were therapy-related.
In plain wordsIn patients with diabetes complications, adverse events occurred in both groups, and none were related to therapy.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
Not applicableAdverse events
Study
n = 110
Comparator
comprehensive treatment alone
Outcome group
Adverse events · Whole body
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
Adverse events
3 events
group 1 (Cortexin plus comprehensive treatment)
Adverse events
2 events
group 2 (comprehensive treatment alone)
Adverse events
5 events
both groups
Source sentences
Summary
The proposed therapy demonstrated a high safety profile, with only 5 AEs reported (3 in Group 1 and 2 in Group 2), none of which were related to the study therapy.
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342211
09HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, average MoCA score rose 1.2-fold after 3 months of follow-up; the abstract does not name the group or comparator.
In plain wordsIn patients with diabetes complications, average MoCA scores rose 1.2-fold after 3 months; the abstract does not name the group.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
IncreaseMoCA score after 3 months of follow-up
Study
n: not reported in source
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
MoCA score increase
1.2 fold
average MoCA score after 3 months of follow-up
Source sentences
Summary
The regression of cognitive symptoms in group 1 patients was superior to that in group 2 (6.0 times vs. 1.7 times), as confirmed by a 1.2-fold increase in the average MoCA score after 3 months of follow-up (p<0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342202
10HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, 83.3% of the Cortexin group showed good or very good CGI improvement.
In plain wordsIn patients with diabetes complications, 83.3% of the Cortexin group showed good or very good improvement.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
Not applicableCGI good or very good improvement
Study
n: not reported in source
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
Patients with good or very good CGI improvement
83.3%
group 1 (Cortexin plus comprehensive treatment)
Source sentences
Summary
According to the CGI scale, 83.3% of patients in group 1 showed good or very good improvement, and a significant therapeutic effect was noted in 55.6% of patients.
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342209
11HumanRandomized controlled trialEfficacy outcome
In patients with neurological complications of diabetes, a significant therapeutic effect on the CGI scale was noted in 55.6% of patients; the abstract does not name the group.
In plain wordsIn patients with diabetes complications, a significant therapeutic effect was noted in 55.6% of patients; the abstract does not name the group.
Peptide
Cortexin (cortical polypeptide complex)
Outcome
Not applicableSignificant therapeutic effect
Study
n: not reported in source
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
10 mg · intramuscular · ten dosesAs given in this study (human).
Measurements
Patients with significant therapeutic effect
55.6%
CGI scale, group not named
Source sentences
Summary
According to the CGI scale, 83.3% of patients in group 1 showed good or very good improvement, and a significant therapeutic effect was noted in 55.6% of patients.
3 context sentences(design, population, supporting numbers)
Summary · context
This multicenter, parallel-group, randomized, clinical trial included 110 patients with neurological complications of T2DM including cognitive impairment, anxiety-depressive states, and a painless diabetic polyneuropathy (DPN).
Summary · context
All patients received comprehensive treatment consisting of glycine and B-vitamin complexes for 30 days-administered parenterally for the first 10 days and orally for the subsequent 20 days.
Summary · context
Group 1 (n=55) patients received ten additional doses of Cortexin 10 mg i/m, while Group 2 patients received only comprehensive treatment.
Report a problemFND-4213342210

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
22 Oct 2026, 02:25 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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[Cortexin in the comprehensive treatment of neurological complications of type 2 diabetes mellitus. (Results of the DIACORT multicenter randomized clinical trial)].

Summary

Results from this study11

Version history

Subjects

Publication types

MeSH terms

Keywords