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

G

Geropharm

Status and phase

Unknown
Phase 3

Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 2

Treatments

Drug: GP40081
Drug: NovoMix 30

Study type

Interventional

Funder types

Industry

Identifiers

NCT04226105
GP40081-P4-31

Details and patient eligibility

About

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®.

Enrollment

264 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Pregnant and breast-feeding women.
  • Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds or ALT or AST value > 3 folds as high as maximal normal value; Serum bilirubin value > 2 folds as high as maximal normal value (except Gilbert's syndrome).
  • History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).
  • Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.
  • Acute inflammation disease for 3 weeks before the screening.
  • History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.
  • History of stroke or TIA for 6 months before the screening.
  • Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).
  • The inability of the patient to assess their condition because of mental or physical disorders.
  • History of drug, alcohol abuse for 3 years before the screening.
  • History of oncology disorders for 5 years before the screening.
  • History of transplantation, except 3 months after a corneal transplant.
  • History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study

Trial design

264 participants in 2 patient groups

GP40081
Experimental group
Description:
Subcutaneous (SC), up to Week 26
Treatment:
Drug: GP40081
NovoMix® 30 FlexPen®
Active Comparator group
Description:
Subcutaneous (SC), up to Week 26
Treatment:
Drug: NovoMix 30

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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