Usefulness and safety of Faster-acting Insuin Aspart is being compared to NovoRapid (Fast acting insulin) both in combination with marketed product Tresiba (Insulin Degludec) in adults with Type-1 diabetes.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/06/007031
• Date of registration: 22-06-2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk India Private Ltd
• Public title: Usefulness and safety of Faster-acting Insuin Aspart is being compared to NovoRapid (Fast acting insulin) both in combination with marketed product Tresiba (Insulin Degludec) in adults with Type-1 diabetes.
• Scientific title: Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes - ONSET 8
• Date of first enrolment: 11-07-2016
• Target sample size: 999
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13695
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy
• Phase: Phase 3

Countries of recruitment

Austria, Bulgaria, Canada, Germany, India, Israel, Italy, Japan, Russian Federation, Serbia , Taiwan, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

Male or female, age >= 18 years (for Japan and Taiwan: age >=20 years) at the time of signing informed consent

Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) >=12 months prior to screening

"Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening

(Visit 1)"

Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1)

HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory

Body Mass Index <= 35.0 kg/m2

"Ability and willingness to adhere to the protocol including performing of self-measured plasma

glucose profiles and meal test"

Ability and willingness to take at least three mealtime boluses a day every day during the trial

"Not currently using real time continuous glucose monitoring system and/or willing not to use a

real time continuous glucose monitoring system during the trial"
Exclusion criteria: Known or suspected hypersensitivity to trial product(s) or related products.

Previous participation in this trial. Participation is defined as signed informed consent

"Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing

potential and not using adequate contraceptive methods (adequate contraceptive measures as

required by local regulation or practice)."

Receipt of any investigational medicinal product within four weeks before screening (Visit 1)

Anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial

"Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization

for unstable angina and/or transient ischemic attack"

Subjects presently classified as being in New York Heart Association Class IV

Currently planned coronary, carotid or peripheral artery revascularisation

"Inadequately treated blood pressure as defined as Class 2 hypertension or higher

(Systolic>=160 mmHg or diastolic >=100 mmHg)"

Impaired liver function, defined as alanine aminotransferase >=2.5 times upper limit of normal

"Renal impairment estimated glomerular filtration rate <=60 mL/min/1.73 m2 as assessed by

central laboratory"

"Anticipated initiation or change in concomitant medications in excess of two weeks known to

affect weight or glucose metabolism, such as weight loss/modifying (e.g. sibutramine, orlistat,

thyroid hormones, corticosteroids)"

"Proliferative retinopathy or maculopathy requiring acute treatment as verified by fundus

photography or dilated fundoscopy performed within three months before screening (Visit 1)"

"Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening

(Visit 1)"

"Treatment with any medication for the indication of diabetes or obesity other than stated in the

inclusion criteria in a period of three months before screening (Visit 1)"

"Diagnosis of malignant neoplasms within the last five years (except basal and squamous cell

skin cancer, polyps and in-situ carcinomas) prior to screening (Visit 1)"

"Any condition which, in the opinion of the Investigator might jeopardise subjectâ??s safety or

compliance with the protocol"

Anticipated initiation in use of real time continuous glucose monitoring system during the trial





Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Type-1 Diabetes in Adults

Intervention(s)

Intervention1: Faster aspart insulin
: Dose: Subjects will be switched from marketed product to trial products by unit-to-unit method
Frequency: 3 times a day
Route of administration: Subcutaneously

Control Intervention1: NovoRapid: NovoRapid
Both in combination with insulin degludec

Dose: Subjects will be switched from marketed product to trial products by unit-to-unit method
Frequency: 3 times a day
Route of administration: Subcutaneously

Primary Outcome(s)

Change from baseline in HbA1c after 26 weeks of treatment

Timepoint: 26 weeks

Secondary Outcome(s)

Change from baseline in 1-hour post prandial glucose increment after 26 weeks of treatment (meal test)

Timepoint: 26 weeks

Change from baseline in 1,5-anhydroglucitol after 26 weeks of treatment

Timepoint: 26 weeks

Secondary ID(s)

NN1218-4131 Version 4.0 dated 29 Jan 2016

U1111-1167-9495

Source(s) of Monetary Support

Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066 India

Ethics review

Status: Approved
Approval date: 25/11/2015
Contact:

Prof. M. Viswanathan Diabetes Research Centre

Status: Approved
Approval date: 18/01/2016
Contact:

Institutional Ethics Committee, Ramdevrao Hospital

Status: Approved
Approval date: 21/01/2016
Contact:

Integrity Ethics Committee, Convenient Hospitals

Status: Approved
Approval date: 22/01/2016
Contact:

Cuttack Diabetes Research Foundation Ethics Committee

Status: Approved
Approval date: 25/01/2016
Contact:

HCG Multi Specialty Ethics Committee

Status: Approved
Approval date: 02/04/2016
Contact:

Institutional Ethics Committee Poona Medical Research Foundation, Ruby Hall Clinic

Status: Approved
Approval date: 09/05/2016
Contact:

KEM Hospital Research centre Ethics Committee

Status: Approved
Approval date: 18/05/2016
Contact:

Sterling Hospital Ethics Committee

Status: Approved
Approval date: 19/05/2016
Contact:

Institutional Ethics Committee Govt. Medical College, Kozhikode

Status: Approved
Approval date: 23/05/2016
Contact:

Institutional Ethics Committee, PGIMS, Rohtak, Haryana

Status: Approved
Approval date: 08/07/2016
Contact:

Institutional Ethics Committee of Madras

Status: Approved
Approval date: 03/08/2016
Contact:

Institutional Ethics Committee , PGIMER, Chandigarh

Status: Approved
Approval date: 26/08/2016
Contact:

Institutional Ethics Committee, King George Hospital

Status: Approved
Approval date: 02/09/2016
Contact:

Institutional Review Board Christian Medical College, Vellore

Status: Approved
Approval date: 03/09/2016
Contact:

Institutional Ethics Committee, AIIMS, New Delhi

Status: Approved
Approval date: 21/09/2016
Contact:

Ethics Committee of Diabetes Thyroid Hormone Research Institute

Status: Not Applicable
Approval date:
Contact:

Institutional Ethics Committee, Dr RML Hospital PGIMER

Results

• Date Completed: 09/08/2017