CTRI/2017/07/009081Active, not recruitingPhase 3
Efficacy and safety of semaglutide versus canagliflozin as add-on to metformin in subjects with type 2 diabetes.
ovo Nordisk India Private Ltd0 sites50 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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