AzTrials
AzTrials

DiabetesPhase 4LIRA-PRIMENCT02730377

Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

A Phase 4 study testing liraglutide, alpha-glucosidase inhibitors and DPP-4 inhibitors in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 232 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
liraglutide, alpha-glucosidase inhibitors and DPP-4 inhibitors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,991 participants
Where
232 sitesin 10 countries
Study dates
28 Mar 2016to 12 Aug 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Trial locations and contacts

232 sites in 10 countries.

232 sites in 10 countries

United States179 sites

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87102

  • Novo Nordisk Investigational Site

    Albuquerque, New Mexico, 87108

  • Novo Nordisk Investigational Site

    Alhambra, California, 91801

  • Novo Nordisk Investigational Site

    Anderson, South Carolina, 29621

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76014-2010

  • Novo Nordisk Investigational Site

    Arlington, Texas, 76015

  • Novo Nordisk Investigational Site

    Asheboro, North Carolina, 27203

  • Novo Nordisk Investigational Site

    Athens, Tennessee, 37303

  • Novo Nordisk Investigational Site

    Aurora, Illinois, 60506

  • Novo Nordisk Investigational Site

    Avon, Indiana, 46123

  • Novo Nordisk Investigational Site

    Bainbridge, Georgia, 39819

  • Novo Nordisk Investigational Site

    Beaver, Pennsylvania, 15009

  • Novo Nordisk Investigational Site

    Bellevue, Washington, 98004-4604

  • Novo Nordisk Investigational Site

    Belzoni, Mississippi, 39038

  • Novo Nordisk Investigational Site

    Birmingham, Alabama, 35211

  • Novo Nordisk Investigational Site

    Bountiful, Utah, 84010

  • Novo Nordisk Investigational Site

    Brooklyn, New York, 11215

  • Novo Nordisk Investigational Site

    Buckley, Michigan, 49620

  • Novo Nordisk Investigational Site

    Buena Park, California, 90620

  • Novo Nordisk Investigational Site

    Burlington, North Carolina, 27215

  • Novo Nordisk Investigational Site

    Butte, Montana, 59701

  • Novo Nordisk Investigational Site

    Carlsbad, California, 92008

  • Novo Nordisk Investigational Site

    Carrollton, Texas, 75010

  • Novo Nordisk Investigational Site

    Centennial, Colorado, 80012

  • Novo Nordisk Investigational Site

    Centennial, Colorado, 80112

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28210

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277-6594

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60616

  • Novo Nordisk Investigational Site

    Chiefland, Florida, 32626

  • Novo Nordisk Investigational Site

    Clearwater, Florida, 33756

  • Novo Nordisk Investigational Site

    Colorado Springs, Colorado, 80906

  • Novo Nordisk Investigational Site

    Columbia, South Carolina, 29223

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43213

  • Novo Nordisk Investigational Site

    Conyers, Georgia, 30094-5965

  • Novo Nordisk Investigational Site

    Coronado, California, 92118

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78413

  • Novo Nordisk Investigational Site

    Costa Mesa, California, 92627

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75251

  • Novo Nordisk Investigational Site

    Danville, Virginia, 24541

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45406

  • Novo Nordisk Investigational Site

    Edmond, Oklahoma, 73034

  • Novo Nordisk Investigational Site

    Elizabeth City, North Carolina, 27909

  • Novo Nordisk Investigational Site

    Elk Grove, California, 95758

  • Novo Nordisk Investigational Site

    Elkridge, Maryland, 21075-6437

  • Novo Nordisk Investigational Site

    Encinitas, California, 92024

  • Novo Nordisk Investigational Site

    Evansville, Indiana, 47714

  • Novo Nordisk Investigational Site

    Fargo, North Dakota, 58104

  • Novo Nordisk Investigational Site

    Fleetwood, Pennsylvania, 19522

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33316

  • Novo Nordisk Investigational Site

    Fort Worth, Texas, 76164

  • Novo Nordisk Investigational Site

    Fountain Hills, Arizona, 85268

  • Novo Nordisk Investigational Site

    Franklin, Ohio, 45005

  • Novo Nordisk Investigational Site

    Fremont, Nebraska, 68025

  • Novo Nordisk Investigational Site

    Garner, North Carolina, 27529

  • Novo Nordisk Investigational Site

    Georgetown, Texas, 78626

  • Novo Nordisk Investigational Site

    Gillespie, Illinois, 62033

  • Novo Nordisk Investigational Site

    Gloucester Courthouse, Virginia, 23061

  • Novo Nordisk Investigational Site

    Golden, Colorado, 80401

  • Novo Nordisk Investigational Site

    Gonzales, Texas, 78629

  • Novo Nordisk Investigational Site

    Greenfield, Indiana, 46140

  • Novo Nordisk Investigational Site

    Greer, South Carolina, 29651

  • Novo Nordisk Investigational Site

    Haleyville, Alabama, 35565-1719

  • Novo Nordisk Investigational Site

    Harleysville, Pennsylvania, 19438

  • Novo Nordisk Investigational Site

    Harrisburg, Arkansas, 72432-1132

  • Novo Nordisk Investigational Site

    Hollywood, Florida, 33024

  • Novo Nordisk Investigational Site

    Houston, Texas, 77024

  • Novo Nordisk Investigational Site

    Houston, Texas, 77025-1669

  • Novo Nordisk Investigational Site

    Houston, Texas, 77061

  • Novo Nordisk Investigational Site

    Houston, Texas, 77074

  • Novo Nordisk Investigational Site

    Houston, Texas, 77079

  • Novo Nordisk Investigational Site

    Houston, Texas, 77081

  • Novo Nordisk Investigational Site

    Humboldt, Tennessee, 38343

  • Novo Nordisk Investigational Site

    Huntington Beach, California, 92646

  • Novo Nordisk Investigational Site

    Irving, Texas, 75061-2210

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32205

  • Novo Nordisk Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • Novo Nordisk Investigational Site

    Kerrville, Texas, 78028

  • Novo Nordisk Investigational Site

    Killeen, Texas, 76543

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34741

  • Novo Nordisk Investigational Site

    La Mirada, California, 90638

  • Novo Nordisk Investigational Site

    Lancaster, California, 93534

  • Novo Nordisk Investigational Site

    Lansdale, Pennsylvania, 19446-1002

  • Novo Nordisk Investigational Site

    Las Vegas, Nevada, 89118

  • Novo Nordisk Investigational Site

    Levittown, Pennsylvania, 19056-2404

  • Novo Nordisk Investigational Site

    Levittown, Pennsylvania, 19056

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Little Rock, Arkansas, 72212

  • Novo Nordisk Investigational Site

    Lomita, California, 90717

  • Novo Nordisk Investigational Site

    Longview, Texas, 75605

  • Novo Nordisk Investigational Site

    Mason, Ohio, 45040-6815

  • Novo Nordisk Investigational Site

    McMurray, Pennsylvania, 15317

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83646

  • Novo Nordisk Investigational Site

    Miami, Florida, 33174

  • Novo Nordisk Investigational Site

    Miami, Florida, 33175

  • Novo Nordisk Investigational Site

    Missoula, Montana, 59808

  • Novo Nordisk Investigational Site

    Missouri City, Texas, 77459

  • Novo Nordisk Investigational Site

    Montclair, California, 91763

  • Novo Nordisk Investigational Site

    Monument, Colorado, 80132

  • Novo Nordisk Investigational Site

    Mooresville, North Carolina, 28117

  • Novo Nordisk Investigational Site

    Morganton, North Carolina, 28655

  • Novo Nordisk Investigational Site

    Muncie, Indiana, 47304

  • Novo Nordisk Investigational Site

    Natchitoches, Louisiana, 71457-5881

  • Novo Nordisk Investigational Site

    New Braunfels, Texas, 78130

  • Novo Nordisk Investigational Site

    New Windsor, New York, 12533

  • Novo Nordisk Investigational Site

    Newton, Kansas, 67114

  • Novo Nordisk Investigational Site

    Norfolk, Virginia, 23510-2015

  • Novo Nordisk Investigational Site

    North Little Rock, Arkansas, 72117

  • Novo Nordisk Investigational Site

    North Massapequa, New York, 11758-1802

  • Novo Nordisk Investigational Site

    Northridge, California, 91325

  • Novo Nordisk Investigational Site

    Ocala, Florida, 34470

  • Novo Nordisk Investigational Site

    Ocoee, Florida, 34761

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73162-4704

  • Novo Nordisk Investigational Site

    Old Point Station, South Carolina, 29707

  • Novo Nordisk Investigational Site

    Omaha, Nebraska, 68144

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32819

  • Novo Nordisk Investigational Site

    Ormond Beach, Florida, 32174-6302

  • Novo Nordisk Investigational Site

    Oviedo, Florida, 32765

  • Novo Nordisk Investigational Site

    Oxnard, California, 93030

  • Novo Nordisk Investigational Site

    Oxon Hill, Maryland, 20745

  • Novo Nordisk Investigational Site

    Palm Harbor, Florida, 34684-3609

  • Novo Nordisk Investigational Site

    Park City, Kansas, 67219

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina, 29669

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33027

  • Novo Nordisk Investigational Site

    Perry, Georgia, 31069

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania, 19114

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85018

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85037

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85050

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15243

  • Novo Nordisk Investigational Site

    Port Gibson, Mississippi, 39150

  • Novo Nordisk Investigational Site

    Providence, Rhode Island, 02908

  • Novo Nordisk Investigational Site

    Rancho Cucamonga, California, 91730-3063

  • Novo Nordisk Investigational Site

    Rapid City, South Dakota, 57702

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23219

  • Novo Nordisk Investigational Site

    Riverside, California, 92506

  • Novo Nordisk Investigational Site

    Rochester, Michigan, 48307

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78240

  • Novo Nordisk Investigational Site

    San Diego, California, 92111

  • Novo Nordisk Investigational Site

    San Diego, California, 92120

  • Novo Nordisk Investigational Site

    San Ramon, California, 94582

  • Novo Nordisk Investigational Site

    Searcy, Arkansas, 72143

  • Novo Nordisk Investigational Site

    Seminole, Florida, 33773

  • Novo Nordisk Investigational Site

    Shreveport, Louisiana, 71105

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina, 29681

  • Novo Nordisk Investigational Site

    Smithfield, Pennsylvania, 15478

  • Novo Nordisk Investigational Site

    Splendora, Texas, 77372

  • Novo Nordisk Investigational Site

    Spokane, Washington, 99216-1557

  • Novo Nordisk Investigational Site

    St. George, Utah, 84790

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida, 33713

  • Novo Nordisk Investigational Site

    Statesboro, Georgia, 30461

  • Novo Nordisk Investigational Site

    Sterling Heights, Michigan, 48310-3503

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77478

  • Novo Nordisk Investigational Site

    Sugar Land, Texas, 77479

  • Novo Nordisk Investigational Site

    Sunset, Louisiana, 70584

  • Novo Nordisk Investigational Site

    Suwanee, Georgia, 30024

  • Novo Nordisk Investigational Site

    Tempe, Arizona, 85283

  • Novo Nordisk Investigational Site

    Toledo, Ohio, 43623

  • Novo Nordisk Investigational Site

    Troy, Michigan, 48098

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85741

  • Novo Nordisk Investigational Site

    Tullahoma, Tennessee, 37388

  • Novo Nordisk Investigational Site

    Tuscumbia, Alabama, 35674

  • Novo Nordisk Investigational Site

    Tustin, California, 92780

  • Novo Nordisk Investigational Site

    Uniontown, Pennsylvania, 15401

  • Novo Nordisk Investigational Site

    Virginia Beach, Virginia, 23454

  • Novo Nordisk Investigational Site

    Waco, Texas, 76710

  • Novo Nordisk Investigational Site

    Wadsworth, Ohio, 44281

  • Novo Nordisk Investigational Site

    Walla Walla, Washington, 99362-4445

  • Novo Nordisk Investigational Site

    Wauconda, Illinois, 60084

  • Novo Nordisk Investigational Site

    Westfield, New York, 14787

  • Novo Nordisk Investigational Site

    Westminster, California, 92683

  • Novo Nordisk Investigational Site

    Whiteville, North Carolina, 28472

  • Novo Nordisk Investigational Site

    Wichita, Kansas, 67205

  • Novo Nordisk Investigational Site

    Woodstock, Georgia, 30189-4255

Other trials in United States

India16 sites

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560 017

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560002

  • Novo Nordisk Investigational Site

    Bangalore, Karnataka, 560054

  • Novo Nordisk Investigational Site

    Hubli, 580022

  • Novo Nordisk Investigational Site

    Hyderabad, Telangana, 500033

  • Novo Nordisk Investigational Site

    Indore, Madhya Pradesh, 452008

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700027

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700054

  • Novo Nordisk Investigational Site

    Lucknow, Uttar Pradesh, 226005

  • Novo Nordisk Investigational Site

    Ludhiana, 141001

  • Novo Nordisk Investigational Site

    Mysore, Karnataka, 570001

  • Novo Nordisk Investigational Site

    Nagpur, Maharashtra, 440003

  • Novo Nordisk Investigational Site

    Noida, Uttar Pradesh, 201301

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411001

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411004

  • Novo Nordisk Investigational Site

    Pune, Maharashtra, 411013

Other trials in India

Canada12 sites

  • Novo Nordisk Investigational Site

    Hamilton, Ontario, L8M 1K7

  • Novo Nordisk Investigational Site

    Montreal, Quebec, H4N 2W2

  • Novo Nordisk Investigational Site

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • Novo Nordisk Investigational Site

    Québec, G1G 3Y8

  • Novo Nordisk Investigational Site

    Saint-Marc-des-Carrieres, Quebec, G0A 4B0

  • Novo Nordisk Investigational Site

    Sarnia, Ontario, N7T 4X3

  • Novo Nordisk Investigational Site

    Strathroy, Ontario, N7G 1Y7

  • Novo Nordisk Investigational Site

    Surrey, British Columbia, V3Z 2N6

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M3J 1N2

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M9V 4B4

  • Novo Nordisk Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • Novo Nordisk Investigational Site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

Russia5 sites

  • Novo Nordisk Investigational Site

    Dzerzhinskiy, 140091

  • Novo Nordisk Investigational Site

    Moscow, 101990

  • Novo Nordisk Investigational Site

    Moscow, 121293

  • Novo Nordisk Investigational Site

    Moscow, 125315

  • Novo Nordisk Investigational Site

    Saint Petersburg, 197762

Other trials in Russia

Lebanon4 sites

  • Novo Nordisk Investigational Site

    Beirut

  • Novo Nordisk Investigational Site

    Byblos

  • Novo Nordisk Investigational Site

    El Achrafiyé

  • Novo Nordisk Investigational Site

    Hazmiyeh

Other trials in Lebanon

Serbia4 sites

  • Novo Nordisk Investigational Site

    Belgrade, 11000

  • Novo Nordisk Investigational Site

    Kragujevac, 34000

  • Novo Nordisk Investigational Site

    Niš, 18000

  • Novo Nordisk Investigational Site

    Novi Sad, 21000

Other trials in Serbia

Turkey (Türkiye)4 sites

  • Novo Nordisk Investigational Site

    Adapazarı, 54290

  • Novo Nordisk Investigational Site

    Istanbul, 34130

  • Novo Nordisk Investigational Site

    Istanbul, 34722

  • Novo Nordisk Investigational Site

    Istanbul, 34890

Other trials in Turkey (Türkiye)

Colombia3 sites

  • Novo Nordisk Investigational Site

    Bogotá, 110221

  • Novo Nordisk Investigational Site

    Bogotá, 111211

  • Novo Nordisk Investigational Site

    Medellín

Other trials in Colombia

Latvia3 sites

  • Novo Nordisk Investigational Site

    Riga, LV1011

  • Novo Nordisk Investigational Site

    Riga, LV1057

  • Novo Nordisk Investigational Site

    Tukums, LV3101

Other trials in Latvia

Puerto Rico2 sites

  • Novo Nordisk Investigational Site

    Toa Baja, 00949

  • Novo Nordisk Investigational Site

    Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy and Treated in a Primary Care Setting

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.

Being tested
liraglutide, alpha-glucosidase inhibitors, DPP-4 inhibitors, meglitinides, SGLT-2 inhibitors
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liraglutideDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • alpha-glucosidase inhibitorsDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • DPP-4 inhibitorsDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • meglitinidesDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • SGLT-2 inhibitorsDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • sulphonylureaDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

  • thiazolidinedionesDrug

    Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Study groups in NCT02730377
Study groupRoleWhat they receive
Liraglutide 1.8 mgExperimentalAdd-on to metformin
Receives: Drug: liraglutide
OADActive comparatorAdd-on to metformin. Treatment with one OAD selected at the discretion of the investigator. Subjects randomised to the OAD arm must remain on the same OAD throughout the trial.
Receives: Drug: alpha-glucosidase inhibitors; Drug: DPP-4 inhibitors; Drug: meglitinides; Drug: SGLT-2 inhibitors; Drug: sulphonylurea; Drug: thiazolidinediones

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Inadequate Glycaemic Control

    Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104.

    Measured: Weeks 26-104

Secondary outcomes (22)

  1. Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control)

    The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function.

    Measured: Weeks 0-104

  2. Change in HbA1c

    Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  3. Participants Who Achieve HbA1c ≤6.5% (Yes/No)

    Participants who achieved HbA1c ≤6.5% (yes/no) is presented.

    Measured: Week 104/Premature treatment discontinuation

  4. Participants Who Achieve HbA1c ≤7.0% Without Weight Gain

    Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented.

    Measured: Week 104/Premature treatment discontinuation

  5. Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes

    Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.

    Measured: Week 104/Premature treatment discontinuation

  6. Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes

    Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented.

    Measured: Week 104/Premature treatment discontinuation

  7. Change in Fasting Plasma Glucose (FPG)

    Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  8. Change in Body Weight

    Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  9. Change in Body Mass Index (BMI)

    Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  10. Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

    Change from baseline (week 0) in systolic and diastolic blood pressure at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  11. Number of Severe Hypoglycaemic Episodes

    Severe hypoglycaemic episodes were defined as episodes that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Number of severe hypoglycaemic episodes that occured during weeks 0-104 are presented.

    Measured: Weeks 0-104

  12. Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

    Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Number of severe or BG confirmed symptomatic hypoglycaemic episodes that occured during weeks 0-104 are presented.

    Measured: Weeks 0-104

  13. Number of Documented Symptomatic Hypoglycaemic Episodes (ADA)

    Documented symptomatic hypoglycaemic were defined as episodes with typical symptoms of hypoglycaemia accompanied by measure plasma glucose concentration <= 3.9 mmol/L. Number of documented symptomatic hypoglycaemic episodes that occured during the weeks 0-104 are presented.

    Measured: Weeks 0-104

  14. Number of Serious Adverse Events (SAEs)

    A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or suspicion of transmission of infectious agents via the trial product. An SAE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent serious adverse events are presented.

    Measured: Weeks 0-105

  15. Number of AEs Leading to Permanent Discontinuation of Trial Product

    An adverse event (AE) was any untoward medical occurrence in a participant who administered a product, and which did not necessarily had a causal relationship with this treatment. An AE was considered as treatment emergent if it had an onset or increase in severity on or after the time of first trial product administration and no later than 7 days after the time of last trial product administration. Number of treatment emergent AEs that led to permanent discontinuation of trial product are presented.

    Measured: Weeks 0-105

  16. Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides

    Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total cholesterol (TC) and triglycerides (TG) at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  17. Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase

    Change from baseline (week 0) in alanine aminotransferase (ALAT), amylase, aspartate aminotransferase (ASAT) and lipase at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  18. Change in Biochemistry- Creatinine, Total Bilirubin

    Change from baseline (week 0) in creatinine and total bilirubin (TB) at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  19. Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum

    The estimated GFR was derived from serum creatinine using the MDRD (Modification of diet in renal disease) formula. eGFR was measured as milliliter per min per specific surface area (mL/min/SSA).

    Measured: Week 0, week 104/premature treatment discontinuation

  20. Change in Potassium

    Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  21. Change in Haemoglobin

    Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

  22. Change in Pulse

    Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented.

    Measured: Week 0, week 104/premature treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study start28 Mar 2016
  3. Primary completion5 Aug 2019
  4. Study completion12 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730377
Sponsor's protocol ID
NN2211-4232
Other IDs
2015-002417-29, U1111-1170-7035, 2015
Acronym
LIRA-PRIME
Status last verified
Jun 2020
First submitted
23 Mar 2016
Last updated
7 Jul 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Unger J, Allison DC, Carlton M, Lakkole K, Lowe D, Murphy G, Panda JK, Sargin M, Kaltoft M, Treppendahl MB, Zoghbi M; LIRA-PRIME global panel. Trial design and baseline data for LIRA-PRIME: A randomized trial investigating the efficacy of liraglutide in controlling glycaemia in type 2 diabetes in a primary care setting. Diabetes Obes Metab. 2019 Jul;21(7):1543-1550. doi: 10.1111/dom.13682. Epub 2019 Mar 26.

    PubMed 30828917

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PubMed 39963952

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing liraglutide, alpha-glucosidase inhibitors and DPP-4 inhibitors in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 232 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 232 sites in United States, India, Canada, Russia, Lebanon and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Inadequate Glycaemic Control (time frame: Weeks 26-104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730377, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in