Phase 3
Completed N=303
LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.
Diabetes · Diabetes Mellitus, Type 2
Source: ClinicalTrials.gov NCT02964247 ↗
Enrolled (actual)
303
Serious AEs
2.0%
Results posted
Jul 2019
Primary outcomePrimary: Change in HbA1c — -1.00; -0.32; -1.05; -0.35 Percentage of HbA1c — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c |
-1.00; -0.32; -1.05; -0.35 | <.001 sig |
| SECONDARY Change in Body Weight |
-2.84; -2.02; -2.89; -2.09 | 0.077 |
| SECONDARY Change in Fasting Plasma Glucose |
-27.00; -11.97 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target |
51.79; 23.16; 48.21; 76.84 | — |
| SECONDARY Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target |
34.36; 9.47; 65.64; 90.53 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain. |
47.69; 19.15; 52.31; 80.85 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%. |
29.74; 7.45; 70.26; 92.55 | — |
| SECONDARY Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile |
-33.93; -18.85 | — |
| SECONDARY Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals) |
-11.06; -4.44 | — |
| SECONDARY Change in Body Mass Index (BMI) |
-1.02; -0.72 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain |
47.69; 19.15; 52.31; 80.85 | — |
| SECONDARY Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg. |
42.05; 18.09; 57.95; 81.91 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) |
52.31; 16.84; 47.69; 83.16 | — |
| SECONDARY Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain |
45.13; 14.89; 54.87; 85.11 | — |
| SECONDARY Number of Treatment Emergent Adverse Events |
426; 106 | — |
| SECONDARY Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes |
0; 3 | — |
| SECONDARY Change in Fasting Blood Lipids - Total Cholesterol |
0.95; 0.99 | — |
| SECONDARY Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol |
0.97; 1.01 | — |
| SECONDARY Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol |
1.05; 1.01 | — |
| SECONDARY Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol |
0.83; 0.94 | — |
| SECONDARY Change in Fasting Blood Lipids-triglycerides |
0.81; 0.93 | — |
| SECONDARY Change in Fasting Blood Lipids- Free Fatty Acids (FFA) |
0.80; 0.86 | — |
| SECONDARY Change in Waist Circumference |
-4.28; -1.77 | — |
| SECONDARY Change in Systolic Blood Pressure |
-1.95; -3.35 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-0.72; -1.12 | — |
| SECONDARY Subjects Who Achieve Weight Loss by 3% or More |
46.43; 41.24; 53.57; 58.76 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02964247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.