A comparative study of Insulin Aspart (manufactured by BioGenomics Ltd) with Insulin Aspart (NovoRapid) in patients of Type 2 Diabetes Mellitus.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/04/018455
• Lead Sponsor: BioGenomics Limited

Brief Summary

The proposed study is designedto compare the efficacy, safety and immunogenicity of insulin aspart [BGL] 100U/mL with NovoRapid® [manufactured by Novo Nordisk], in patients with Type2 (T2DM) diabetes mellitus.

This phase 3 study is for 6months inclusive of the immunogenicity testing including 320 subjects. It aimsto compare immunogenicity of insulin aspart [BGL] with NovoRapid® [manufacturedby Novo Nordisk], by testing the anti-insulin antibodies. The study gives adetailed comprehensive safety profile of insulin aspart [BGL] with referenceproduct NovoRapid® [manufactured by Novo Nordisk].

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Study Completion: 2022-04-03
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Patients who meet all of the following criteria will be included in the study: 1.Type 2 DM patients willing to give written informed consent and willing to take a maximum of 4 injections daily.
• 2.Patients with T2DM, diagnosed since at least 6 months, who have been treated with premix human insulin (one or more insulin injections), who are insulin aspart/insulin aspart mixes’ naive, daily for 3 months prior to the screening visit.
• 3.Current treatment with/without OADs; in case of patients on OADs unchanged dosing for 3 months prior to the screening visit.
• 4.HbA1c between 7.5% -10.0%, both inclusive.
• 5.Both sexes aged between 18 to 65 years.
• 6.Body Mass Index (BMI) ≥18kg/m2and ≤ 40 kg/m2.
• 7.Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control.
• 8.Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.

Exclusion Criteria

• Patients who meet any of the following criteria will be excluded from the study: 1.Known or suspected hypersensitivity to insulin or related product(s).
• 2.Previous participation in this trial (participation is defined as randomization).
• 3.Patients on insulin analogs (other than premix human insulin).
• 4.Patients who have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening or are likely to simultaneously participate in another therapeutic clinical study.
• 5.Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the trial data.
• 6.Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New York Heart Association, within 6 months prior to screening.
• 7.Impaired liver function, defined as alanine transaminase ≥2.5 times upper limit of normal.
• 8.Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
• 9.Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
• 10.Patients who have active proliferative retinopathy or macular edema.
• 11.Known/screening seropositive patients of HIV or HBV or HCV.
• 12.Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NovoRapid® (manufactured by Novo Nordisk) by measuring Mean change in glycated haemoglobin (A1C) from Baseline to end of 12 weeks and from Baseline to end of 24 weeks	From baseline to end of 12 weeks and from baseline to end of 24 weeks
To compare the efficacy of recombinant insulin aspart (manufactured by BGL) with	From baseline to end of 12 weeks and from baseline to end of 24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change in the fasting plasma glucose from baseline to end of 12 weeks and from baseline to end of 24 weeks Mean change in the post-prandial plasma glucose (after standard meal challenge) from baseline to end of 12 weeks and from baseline to end of 24 weeks	Proportion of patients who achieve target A1C (7%) between the treatment groups at the end of 12 weeks and 24weeks.

Trial Locations

Locations (27)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, DELHI, India

AMRI Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Gleneagles Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospital & Research Center; 🇮🇳 Khordha, ORISSA, India

Arthur Asirvatham Hospital; 🇮🇳 Madurai, TAMIL NADU, India

Ashirwad Hospital & Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Atharva Multispeciality Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Diabetes Thyroid & Endocrine Centre,Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Dr. Ram Manohar Lohia Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Fortis Hospital,; 🇮🇳 Rupnagar, PUNJAB, India

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All India Institute of Medical Sciences (AIIMS)

🇮🇳Delhi, DELHI, India

Dr Naval K Vikram

Principal investigator

011-26593678

navalvikram@gmail.com