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Clinical Trials/NCT02964247
NCT02964247
Completed
Phase 3

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

Novo Nordisk A/S1 site in 1 country303 target enrollmentStarted: March 3, 2017Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 2
Interventionsliraglutideplacebo
Drugsliraglutideplacebo

Overview

Phase
Phase 3
Status
Completed
Enrollment
303
Locations
1
Primary Endpoint
Change in HbA1c
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

liraglutide + SGLT2i ± metformin

Experimental

Intervention: liraglutide (Drug)

liraglutide placebo + SGLT2i ± metformin

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Change in HbA1c

Time Frame: Week 0, Week 26

Change from baseline (week 0) to week 26 in glycosylated haemoglobin was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication" observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications.

Secondary Outcomes

  • Change in Body Weight(Week 0, Week 26)
  • Change in Fasting Plasma Glucose(Week 0, Week 26)
  • Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target(Week 26)
  • Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target(Week 26)
  • Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.(Week 26)
  • Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.(Week 26)
  • Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile(Week 0, Week 26)
  • Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)(Week 0, Week 26)
  • Change in Body Mass Index (BMI)(Week 0, Week 26)
  • Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain(Week 26)
  • Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.(Week 26)
  • Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain(Week 26)
  • Number of Treatment Emergent Adverse Events(Week 0 - 26 + 7 days)
  • Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)(Week 26)
  • Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol(Week 0, Week 26)
  • Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol(Week 0, Week 26)
  • Change in Fasting Blood Lipids- Free Fatty Acids (FFA)(Week 0, Week 26)
  • Change in Systolic Blood Pressure(Week 0, Week 26)
  • Change in Diastolic Blood Pressure(Week 0, Week 26)
  • Subjects Who Achieve Weight Loss by 3% or More(Week 26)
  • Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes(Week 0 - 26)
  • Change in Fasting Blood Lipids - Total Cholesterol(Week 0, Week 26)
  • Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol(Week 0, Week 26)
  • Change in Fasting Blood Lipids-triglycerides(Week 0, Week 26)
  • Change in Waist Circumference(Week 0, Week 26)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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