Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients

NCT04226105 | Unknown Phase 3

• 1 other identifier: GP40081-P4-31
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 14

Brief Summary

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  Change from baseline in titer of antibodies to human insulin

  26 weeks

Secondary Outcomes (9)

• Glycated hemoglobin

  26 weeks

• Adverse Events frequency and degree

  26 weeks

• Fasting Plasma Glucose Level

  26 weeks

• Seven-Point Glucose Testing

  22 weeks

• Total Insulin Dose

  22 weeks

Study Arms (2)

GP40081

EXPERIMENTAL

Subcutaneous (SC), up to Week 26

Drug: GP40081

NovoMix® 30 FlexPen®

ACTIVE COMPARATOR

Subcutaneous (SC), up to Week 26

Drug: NovoMix 30

Interventions

GP40081 DRUG

1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

Also known as: Insulin aspart 30 mix

GP40081

NovoMix 30 DRUG

1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

Also known as: Insulin aspart 30 mix

NovoMix® 30 FlexPen®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written consent
• Diabetes mellitus type 2 for at least 6 months before the screening (WHO criteria 1999-2013).
• Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).
• Indications for exogenous insulin therapy.
• Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).
• Insulin-naive patients or prior insulin therapy at least 6 months before randomization.
• The subject is able and willing to comply with the requirements of the study protocol

You may not qualify if:

• Contraindication to the use of insulin aspart 30 mix.
• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions.
• History of severe hypoglycemia for 6 months before the screening.
• History of severe hyperglycemia for 6 months before the screening.
• Bariatric surgery for 12 months to screening.
• Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.
• Insulin resistance over 1.5 U/kg insulin pro day.
• Change INN of insulin for 6 months before the randomisation.
• History of treatment any experimental drugs or medical devices for 3 months before the randomisation.
• Presence of severe diabetes complications.
• Night work.
• History of administration of glucocorticoids (14 days or more) for 1 year before the screening.
• Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).
• History of vaccination for 6 months before the randomisation.
• History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (14)

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Kazan Endocrinology Dispensary

Kazan', 420073, Russia

Location

Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky

Krasnoyarsk, 660022, Russia

Location

V.A. Baranov Republic Hospital

Petrozavodsk, 185000, Russia

Location

City Diagnostic Center № 1

Saint Petersburg, 194354, Russia

Location

City Hospital № 2

Saint Petersburg, 194354, Russia

Location

City Polyclinic № 117

Saint Petersburg, 194358, Russia

Location

EosMed

Saint Petersburg, 195197, Russia

Location

Institute of Medical Research

Saint Petersburg, 196084, Russia

Location

Research Center Eco-Safety

Saint Petersburg, 196143, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Pokrovskaya Municipal Hospital

Saint Petersburg, 199106, Russia

Location

Diabetes Center

Samara, 443067, Russia

Location

Volgograd Region Clinical Hospital №1

Volgograd, 400081, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 20, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 25, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)