Trial Outcomes & Findings for Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (NCT NCT01898286)

NCT ID: NCT01898286

Last Updated: 2016-05-26

Results Overview

The number of hypoglycemic events recorded by each patient over the course of the study.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 38 participants
• Primary outcome timeframe: At Early Termination Visit, Up to 25 Months
• Results posted on: 2016-05-26

Participant Flow

Patients diagnosed with Type 1 diabetes mellitus up to six months before randomization to Study 1001 (NCT01103284), from medical sites in the EU, US, Russia, and Israel

Participant milestones

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Study STARTED	38
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

Baseline characteristics by cohort

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=38 Participants All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Age, Continuous	33.16 years STANDARD_DEVIATION 7.343 • n=5 Participants
Age, Customized	32.00 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	33 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants
Race/Ethnicity, Customized Black	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants

PRIMARY outcome

Timeframe: At Early Termination Visit, Up to 25 Months

Population: Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.

The number of hypoglycemic events recorded by each patient over the course of the study.

Outcome measures

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=16 Participants All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Hypoglycemic Events	3.3 hypoglycemic events Standard Deviation 3.30

SECONDARY outcome

Timeframe: Baseline and Early Termination Visit, Up to 25 Months

Population: Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.

Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.

Outcome measures

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=9 Participants All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit	0.2 nmol*minute/L Standard Deviation 2.334

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Early Termination Visit, up to 25 months

Population: All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.

Outcome measures

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=11 Participants All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit	0.025 IU/kg Standard Deviation 0.0270

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Early Termination Visit, Up to 25 Months

Population: All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.

Outcome measures

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=5 Participants All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Glycemic Control (Change From Baseline in % HbA1c)	0.46 % HbA1c Standard Deviation 0.907

Adverse Events

Patients Treated With DiaPep (Originally Enrolled in Study1001

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=38 participants at risk All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Immune system disorders Anaphylaxic shock for glucagon	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit

Other adverse events

Measure	Patients Treated With DiaPep (Originally Enrolled in Study1001 n=38 participants at risk All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Investigations Blood cholesterol increased	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Investigations Low density lipoprotein increased	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Investigations Urine albumin/creatinine ratio increased	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Infections and infestations Nasopharyngitis	5.3% 2/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Infections and infestations Influenza	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Infections and infestations Urinary tract infection	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Investigations Electrocardiogram QT prolonged	5.3% 2/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
General disorders Injection site erythema	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
General disorders Non-cardiac chest pain	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Psychiatric disorders Anxiety	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Psychiatric disorders Social phobia	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Blood and lymphatic system disorders Pancytopenia	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Injury, poisoning and procedural complications Contusion	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Nervous system disorders Syncope	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit
Renal and urinary disorders Dysuria	2.6% 1/38 • AE data were collected from the time of subject enrollment through each subject's early termination visit

Additional Information

Dr. Jeanne Novak

CBR International

Phone: 7207461190

Email: jnovak@cbrintl.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator shall submit any paper or presentation to the Sponsor for review and comments at least 60 days prior to submitting the same to a third party. Upon receiving any request from the Sponsor to delete any Confidential Information or request to delay in publication up to 90 days to allow the filing of any Sponsor application, the Investigator shall take the request action. Investigator shall not be restricted after 18 months from completion of their site's performance in the study.
• Publication restrictions are in place

Restriction type: OTHER