To Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2017/01/007650
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
1. 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
2. Male or female, age >= 18 years at the time of signing informed consent
3. Diagnosed with type 2 diabetes mellitus
4. Treated with any basal insulin >= 90 days prior to the day of screening
5. Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of
OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the
following anti-diabetic drug(s)/regimen:
a. Biguanides (metformin >= 1500 mg or maximum tolerated dose documented in the
subject medical record)
b. Other OADs (>= half of the maximum approved dose according to local label or
maximum tolerated dose as documented in subject medical record):
i. Insulin secretagogues (SU and glinides)
ii. DPP-4 inhibitors
iii. alpha glucosidase inhibitors
iv. SGLT-2 inhibitors
v. Oral combination products (of the allowed individual OADs)
6. HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
7. Body mass index (BMI) <= 45.0 kg/m2
8. Ability and willingness to adhere to the protocol including self-measurement of plasma
glucose according to the protocol
1. Known or suspected hypersensitivity to trial product(s) or related products
2. Previous participation in this trial. Participation is defined as signed informed consent
3. 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)
4. Participation in any clinical trial of an approved or non-approved investigationalmedicinal
product within four weeks prior to the day of screening (V1)
5. Any chronic disorder or severe disease which, in the opinion of the investigator, might
jeopardise subjectâ??s safety or compliance with the protocol
6. Acute decompensation of glycaemic control requiring immediate intensification of treatment
to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) <= 90 days prior to the
day of the screening
7. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or
transient ischaemic attack within the past 180 days prior to the day of screening and between
screening and randomisation
8. Subjects presently classified as being in New York Heart Association (NYHA) Class IV
9. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60
ml/min/1.73 m2 as defined by KDIGO 2012 classification using isotope dilution mass
spectrometry (IDMS) for serum creatinine measured at screening
11. Impaired liver function, defined as ALT >= 2.5 times upper normal limit (UNL) at screening
12. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic
>=180 mmHg or diastolic >=110 mmHg) at screening
13. Treatment with any medication for the indication of diabetes or obesity other than stated in
the inclusion criteria in a period of 90 days before the day of screening
14. Anticipated initiation or change in concomitant medications (for more than 14 consecutive
days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid
hormones, or corticosteroids)
15. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within 90 days prior to randomisation
16. Presence or history of malignant neoplasms within the past five years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in glycosylated haemoglobin (HbA1c) (%) <br/ ><br>Timepoint: week 0 to week 26 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 9-point profileTimepoint: After 38 weeks;Change from baseline in fasting plasma glucose (FPG) after 38 weeksTimepoint: after 38 weeks;Change from baseline in HbA1c (%) after 38 weeks <br/ ><br>Timepoint: After 38 weeks;Mean pre-breakfast measurements used for titrationTimepoint: After 38 weeks;Post-prandial incrementsTimepoint: After 38 weeks;Responder (Yes/No) for HbA1c after 38 weeks: <br/ ><br>o HbA1c (less than 7% <br/ ><br>o HbA1c less than 7% without nocturnal (00:01-05:59) BG confirmed symptomatic hypoglycaemiaTimepoint: After 38 weeks;Self-measured plasma glucose measurements (SMPG) after 38 weeksTimepoint: after 38 weeks