Phase 3 · Liraglutide

NCT02964247 trial results

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

Participants
303
Status
completed
Completed
2018-05-08
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02964247), updated at source Nov 17, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02964247 measured first

Change in HbA1cPercentage of HbA1c · Week 0, Week 26 · mean
MeasureLiraglutiden=203Placebon=100
in-trial obs. period-1.00(0.86)-0.32(0.83)
on-treatment without rescue medication obs. period-1.05(0.85)-0.35(0.80)
Side effects by arm

Side effects in NCT02964247

Percent of participants affected, Week 0 (randomisation visit) to week 26 (end-of-treatment visit) + 7 days. The most common events the registry lists.

EventLiraglutidePlacebo
Any serious event2.5%1%
Nausea26.2%6%
Decreased appetite9.4%0%
Diarrhoea9.4%3%
Constipation8.9%0%
Vomiting8.4%2%
Secondary outcomes

What else it measured

Change in Body WeightKg · Week 0, Week 26 · mean
MeasureLiraglutiden=203Placebon=100
in-trial obs. period-2.84(3.83)-2.02(3.32)
on-treatment without rescue medication obs. period-2.89(3.81)-2.09(2.96)
Change in Fasting Plasma Glucosemilligram/dL · Week 0, Week 26 · mean
Liraglutiden=203Placebon=100
-27.00(35.01)-11.97(45.20)
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association TargetPercentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=95
Yes51.7923.16
No48.2176.84
Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists TargetPercentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=95
Yes34.369.47
No65.6490.53
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.Percentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=94
Yes47.6919.15
No52.3180.85
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.Percentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=94
Yes29.747.45
No70.2692.55
Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profilemilligram/dL · Week 0, Week 26 · mean
Liraglutiden=203Placebon=100
-33.93(37.17)-18.85(40.81)
Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)milligram/dL · Week 0, Week 26 · mean
Liraglutiden=203Placebon=100
-11.06(41.29)-4.44(44.77)
Change in Body Mass Index (BMI)kg/m^2 · Week 0, Week 26 · mean
Liraglutiden=203Placebon=100
-1.02(1.40)-0.72(1.20)
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight GainPercentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=94
Yes47.6919.15
No52.3180.85
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.Percentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=94
Yes42.0518.09
No57.9581.91
Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)Percentage of Participants · Week 26 · number
MeasureLiraglutiden=195Placebon=95
Yes52.3116.84
No47.6983.16
The trial

How NCT02964247 was run

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.

  • liraglutide + SGLT2i ± metformin
  • liraglutide placebo + SGLT2i ± metformin
Who could join the trial

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.

Published papers

Papers from NCT02964247

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.