This trial will study if it is beneficial in terms of blood sugar control, and safe, to add liraglutide to anti-diabetes medication like sodium-glucose co- transporter 2 (SGLT2) inhibitor with or without metformin.
Phase 3
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- CTRI/2017/07/008990
- Lead Sponsor
- Novo Nordisk India Private Ltd
- Brief Summary
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|This is a 26-week, confirmatory, randomised, double-blind, placebo-controlled, multicentre,
|multinational, two-arm, parallel-group trial, investigating the effect and safety of adding liraglutide
|1.8 mg/day to pre-trial treatment with any SGLT2 inhibitor (as monotherapy or in combination with
|metformin) in subjects with T2DM who have not achieved adequate glycaemic control despite
|stable treatment with SGLT2 inhibitor ± metformin for at least 90 days prior to trial participation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 303
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 at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus.
- HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (≥ 1500 mg or maximum tolerated dose) for at least 90 days prior to the day of screening.
- All medications in compliance with current local label.
- Body mass index greater than 20 kg/m2.".
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 an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).Brazil: According to resolution 466/12: Regarding exclusion criterion: Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- For women who expressly declare free of the risk of pregnancy, either by not engaging in sexual activity or by having sexual activity with no birth potential risk, use of contraceptive method will not be mandatory.
- Receipt of any investigational medicinal product within 90 days before screening.
- 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 during the 90 days prior to the day of screening is allowed.
- Any disorder which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
- History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Family is defined as a first degree relative.
- History or presence of pancreatitis (acute or chronic).
- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 mL/min/1.73m2 as defined by KDIGO1 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at 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.
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
- Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic ≥180 mmHg or diastolic ≥110 mmHg) at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin on glycaemic control in subjects with type 2 diabetes mellitus. Change from baseline to week 26
- Secondary Outcome Measures
Name Time Method To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin in subjects with type 2 diabetes mellitus with regards to:
Trial Locations
- Locations (9)
Gandhi Medical College and Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
AMC MET Medical College Sheth L. G. General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Deenanath Mangeshkar Hospital and research centre
🇮🇳Pune, MAHARASHTRA, India
Diabetes, Thyroid and Endocrine centre
🇮🇳Jaipur, RAJASTHAN, India
ILS
🇮🇳Kolkata, WEST BENGAL, India
Kovai Diabetic Speciality Centre & Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Lady Hardinge Medical College and S.S.K. Hospital
🇮🇳Delhi, DELHI, India
Manipal Hospitals
🇮🇳Bangalore, KARNATAKA, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, MADHYA PRADESH, India
Gandhi Medical College and Hospital🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDr D Vijay Shekhar ReddyPrincipal investigator9849172161drdvsreddyendo@yahoo.com