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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date March 3, 2017
Completion Date May 8, 2018
Primary Completion Date May 4, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HbA1c Week 0, Week 26
Secondary Outcome
Measure Time Frame
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) 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
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 - 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-triglycerides Week 0, Week 26
Change in Fasting Blood Lipids- Free Fatty Acids (FFA) Week 0, Week 26
Change in Waist Circumference 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
Enrollment 303
Condition
Intervention

Intervention Type: Drug

Intervention Name: liraglutide

Description: Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Arm Group Label: liraglutide + SGLT2i ± metformin

Intervention Type: Drug

Intervention Name: placebo

Description: Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks

Arm Group Label: liraglutide placebo + SGLT2i ± metformin

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Novo Nordisk Investigational Site | Birmingham, Alabama, 35294, United States
Novo Nordisk Investigational Site | Montgomery, Alabama, 36109, United States
Novo Nordisk Investigational Site | Tucson, Arizona, 85741, United States
Novo Nordisk Investigational Site | Lancaster, California, 93534, United States
Novo Nordisk Investigational Site | Northridge, California, 91325, United States
Novo Nordisk Investigational Site | Sacramento, California, 95821, United States
Novo Nordisk Investigational Site | San Diego, California, 92111, United States
Novo Nordisk Investigational Site | San Ramon, California, 94583, United States
Novo Nordisk Investigational Site | Vista, California, 92083, United States
Novo Nordisk Investigational Site | Gainesville, Florida, 32653, United States
Novo Nordisk Investigational Site | Hollywood, Florida, 33024, United States
Novo Nordisk Investigational Site | Jacksonville, Florida, 32216, United States
Novo Nordisk Investigational Site | Jacksonville, Florida, 32256, United States
Novo Nordisk Investigational Site | Jacksonville, Florida, 32258, United States
Novo Nordisk Investigational Site | Maitland, Florida, 32751, United States
Novo Nordisk Investigational Site | Miami Lakes, Florida, 33016, United States
Novo Nordisk Investigational Site | Miami, Florida, 33165, United States
Novo Nordisk Investigational Site | Miami, Florida, 33176, United States
Novo Nordisk Investigational Site | Tampa, Florida, 33606, United States
Novo Nordisk Investigational Site | Lawrenceville, Georgia, 30046, United States
Novo Nordisk Investigational Site | Roswell, Georgia, 30076, United States
Novo Nordisk Investigational Site | Statesboro, Georgia, 30461, United States
Novo Nordisk Investigational Site | Blackfoot, Idaho, 83221, United States
Novo Nordisk Investigational Site | Evansville, Indiana, 47714, United States
Novo Nordisk Investigational Site | Topeka, Kansas, 66606, United States
Novo Nordisk Investigational Site | Lexington, Kentucky, 40503, United States
Novo Nordisk Investigational Site | New Orleans, Louisiana, 70115, United States
Novo Nordisk Investigational Site | Kalamazoo, Michigan, 49009, United States
Novo Nordisk Investigational Site | Rochester, Michigan, 48307, United States
Novo Nordisk Investigational Site | Billings, Montana, 59101, United States
Novo Nordisk Investigational Site | Henderson, Nevada, 89052-2649, United States
Novo Nordisk Investigational Site | Albany, New York, 12206, United States
Novo Nordisk Investigational Site | West Seneca, New York, 14224, United States
Novo Nordisk Investigational Site | Charlotte, North Carolina, 28210, United States
Novo Nordisk Investigational Site | Charlotte, North Carolina, 28226, United States
Novo Nordisk Investigational Site | Charlotte, North Carolina, 28277, United States
Novo Nordisk Investigational Site | Kinston, North Carolina, 28501, United States
Novo Nordisk Investigational Site | Wilmington, North Carolina, 28401, United States
Novo Nordisk Investigational Site | Cincinnati, Ohio, 45245, United States
Novo Nordisk Investigational Site | Columbus, Ohio, 43212, United States
Novo Nordisk Investigational Site | McMurray, Pennsylvania, 15317, United States
Novo Nordisk Investigational Site | Pittsburgh, Pennsylvania, 15243, United States
Novo Nordisk Investigational Site | Moncks Corner, South Carolina, 29461, United States
Novo Nordisk Investigational Site | Mount Pleasant, South Carolina, 29464, United States
Novo Nordisk Investigational Site | Myrtle Beach, South Carolina, 29572, United States
Novo Nordisk Investigational Site | Spartanburg, South Carolina, 29303, United States
Novo Nordisk Investigational Site | Memphis, Tennessee, 38119, United States
Novo Nordisk Investigational Site | Nashville, Tennessee, 37203, United States
Novo Nordisk Investigational Site | Dallas, Texas, 75231, United States
Novo Nordisk Investigational Site | Edinburg, Texas, 78539, United States
Novo Nordisk Investigational Site | Houston, Texas, 77024, United States
Novo Nordisk Investigational Site | Houston, Texas, 77030, United States
Novo Nordisk Investigational Site | Humble, Texas, 77338, United States
Novo Nordisk Investigational Site | Round Rock, Texas, 78681, United States
Novo Nordisk Investigational Site | Schertz, Texas, 78154, United States
Novo Nordisk Investigational Site | Spokane, Washington, 99201, United States
Novo Nordisk Investigational Site | Curitiba, Parana, 80030-110, Brazil
Novo Nordisk Investigational Site | Porto Alegre, Rio Grande Do Sul, 90035-170, Brazil
Novo Nordisk Investigational Site | São Paulo, Sao Paulo, 01228-000, Brazil
Novo Nordisk Investigational Site | Hyderabad, Andhra Pradesh, 500003, India
Novo Nordisk Investigational Site | Ahmedabad, Gujarat, 380008, India
Novo Nordisk Investigational Site | Bangalore, Karnataka, 560 017, India
Novo Nordisk Investigational Site | Indore, Madhya Pradesh, 452010, India
Novo Nordisk Investigational Site | Pune, Maharashtra, 411004, India
Novo Nordisk Investigational Site | Jaipur, Rajasthan, 302006, India
Novo Nordisk Investigational Site | Coimbatore, Tamil Nadu, 641009, India
Novo Nordisk Investigational Site | Kolkata, West Bengal, 700080, India
Novo Nordisk Investigational Site | New Delhi, 110001, India
Novo Nordisk Investigational Site | Haifa, 35152, Israel
Novo Nordisk Investigational Site | Kfar Saba, 44281, Israel
Novo Nordisk Investigational Site | Tel Hashomer, 52621, Israel
Novo Nordisk Investigational Site | Tel-Aviv, 62038, Israel
Novo Nordisk Investigational Site | Ponce, 00716, Puerto Rico
Novo Nordisk Investigational Site | Saint-Petersburg, 190013, Russian Federation
Novo Nordisk Investigational Site | Saint-Petersburg, 190068, Russian Federation
Novo Nordisk Investigational Site | Saint-Petersburg, 195197, Russian Federation
Novo Nordisk Investigational Site | Saint-Petersburg, 199226, Russian Federation
Novo Nordisk Investigational Site | St. Petersburg, 194354, Russian Federation
Novo Nordisk Investigational Site | Al Ain, 1006, United Arab Emirates
Novo Nordisk Investigational Site | Dubai, 7272, United Arab Emirates
Novo Nordisk Investigational Site | Umm Al Quwain, 24, United Arab Emirates
Novo Nordisk Investigational Site | Umm Al Quwain, 499, United Arab Emirates
Location Countries

Brazil

India

Israel

Puerto Rico

Russian Federation

United Arab Emirates

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: liraglutide + SGLT2i ± metformin

Type: Experimental

Label: liraglutide placebo + SGLT2i ± metformin

Type: Placebo Comparator

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov