The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformi
- Conditions
- Health Condition 1: null- Type 2 DiabetesHealth Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2017/07/009081
- Lead Sponsor
- ovo Nordisk India Private Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 50
a. 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.
b.Male or female, age >=18 years at the time of signing informed consent.
c.Diagnosed with type 2 diabetes mellitus (T2D).
d.HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive).
e. Stable daily dose of metformin (>=1500 mg or maximum tolerated dose as documented in the
subject medical record and in compliance with current local label) for at least 90 days prior
to the day of screening.
a. Known or suspected hypersensitivity to trial product(s) or related products.
b. Previous participation in this trial.
c.Participation is defined as signed informed consent.
d.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
e.Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening.
f.Any disorder which in the investigatorâ??s opinion might jeopardise subjectâ??s
safety or compliance with the protocol.
Subject with alanine aminotransferase (ALT) >2.5 x upper normal limit (UNL).
g.Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative.
h. History or presence of pancreatitis (acute or chronic).
i.History of diabetic ketoacidosis (DKA).
Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
j. Renal impairment measured as eGFR <60 ml/min/1.73 m2 as defined by Kidney Disease
Improving global outcomes (KDIGO 2012)1 classification using isotope dilution mass
spectrometry (IDMS) for serum creatinine measured at screening.
k.Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
l.Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus
photography or dilated fundoscopy performed within the past 90 days prior to
randomisation.
m.Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
n.Medical history of diabetes-related lower limb amputations or signs of critical lower limbischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to
screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline to week 52 in HbA1c <br/ ><br> <br/ ><br>Timepoint: week 0 to week 52 <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Change from baseline to week 52 in: <br/ ><br>- Fasting Plasma Glucose (FPG) <br/ ><br>- Systolic and diastolic blood pressure <br/ ><br>- Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment satisfaction score (sum of 6 <br/ ><br>of 8 items) and the 8 items separately <br/ ><br>Timepoint: week 0 to week 52