LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02964247
• Date of registration: 11/11/2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.
• Scientific title: LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors
• Date of first enrolment: March 3, 2017
• Target sample size: 303
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02964247
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Brazil, India, Israel, Puerto Rico, Russian Federation, United Arab Emirates, United States

Key inclusion & exclusion criteria

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 or older 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 more, 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 of 20 kg/m^2 or above.

Exclusion Criteria:

- 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).

- History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.

- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
than 60 mL/min/1.73m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO)
classification using isotope dilution mass spectrometry (IDMS) for serum creatinine
measured at 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 screening is allowed.

- 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).

- Impaired liver function, defined as ALT 2.5 or more times upper normal limit at
screening.

- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: liraglutide

Drug: placebo

Primary Outcome(s)

Change in HbA1c [Time Frame: Week 0, Week 26]

Secondary Outcome(s)

Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol [Time Frame: Week 0, Week 26]

Change in Fasting Plasma Glucose [Time Frame: Week 0, Week 26]

Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals) [Time Frame: Week 0, Week 26]

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes [Time Frame: Week 0 - 26]

Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol [Time Frame: Week 0, Week 26]

Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol [Time Frame: Week 0, Week 26]

Change in Body Weight [Time Frame: Week 0, Week 26]

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg. [Time Frame: Week 26]

Change in Fasting Blood Lipids-triglycerides [Time Frame: Week 0, Week 26]

Change in Waist Circumference [Time Frame: Week 0, Week 26]

Change in Fasting Blood Lipids- Free Fatty Acids (FFA) [Time Frame: Week 0, Week 26]

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain [Time Frame: Week 26]

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%. [Time Frame: Week 26]

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) [Time Frame: Week 26]

Number of Treatment Emergent Adverse Events [Time Frame: Week 0 - 26 + 7 days]

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain. [Time Frame: Week 26]

Subjects Who Achieve Weight Loss by 3% or More [Time Frame: Week 26]

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target [Time Frame: Week 26]

Change in Body Mass Index (BMI) [Time Frame: Week 0, Week 26]

Change in Fasting Blood Lipids - Total Cholesterol [Time Frame: Week 0, Week 26]

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target [Time Frame: Week 26]

Change in Diastolic Blood Pressure [Time Frame: Week 0, Week 26]

Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile [Time Frame: Week 0, Week 26]

Change in Systolic Blood Pressure [Time Frame: Week 0, Week 26]

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain [Time Frame: Week 26]

Secondary ID(s)

U1111-1184-8086

NN2211-4315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02964247