sefulness 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.
- Conditions
- Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Type-1 Diabetes in Adults
- Registration Number
- CTRI/2016/06/007031
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 107
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c after 26 weeks of treatment <br/ ><br>Timepoint: 26 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in 1,5-anhydroglucitol after 26 weeks of treatment <br/ ><br>Timepoint: 26 weeks;Change from baseline in 1-hour post prandial glucose increment after 26 weeks of treatment (meal test) <br/ ><br>Timepoint: 26 weeks