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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002417-29 | EudraCT Number | ||
| U1111-1170-7035 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 1.8 mg | Experimental | Add-on to metformin |
|
| OAD | Active Comparator | Add-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 26-104 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35211 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30828917 | Background | 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. | |
| 39963952 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Participants were randomised in a 1:1 manner to receive either liraglutide or an oral antidiabetic drug (OAD) both as add-on to background therapy with metformin.
The trial was conducted at 219 sites in Canada (11), Colombia (3), India (16), Latvia (2), Lebanon (4), Russian Federation (5), Serbia (6), Turkey (4) and the United States (168).
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide 1.8 mg | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2020 | Jun 16, 2020 |
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| alpha-glucosidase inhibitors | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| DPP-4 inhibitors | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| meglitinides | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| SGLT-2 inhibitors | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| sulphonylurea | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| thiazolidinediones | Drug | Trial product will be prescribed by the investigator and dispensed by pharmacy or similar. |
|
| Weeks 0-104 |
| Change in HbA1c | Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Participants who achieved HbA1c ≤6.5% (yes/no) is presented. | Week 104/Premature treatment discontinuation |
| Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented. | Week 104/Premature treatment discontinuation |
| 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. | Week 104/Premature treatment discontinuation |
| 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. | Week 104/Premature treatment discontinuation |
| Change in Fasting Plasma Glucose (FPG) | Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Change in Body Weight | Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Change in Body Mass Index (BMI) | Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| 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. | Week 0, week 104/premature treatment discontinuation |
| 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. | Weeks 0-104 |
| 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. | Weeks 0-104 |
| 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. | Weeks 0-104 |
| 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. | Weeks 0-105 |
| 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. | Weeks 0-105 |
| 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. | Week 0, week 104/premature treatment discontinuation |
| 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. | Week 0, week 104/premature treatment discontinuation |
| 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. | Week 0, week 104/premature treatment discontinuation |
| 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). | Week 0, week 104/premature treatment discontinuation |
| Change in Potassium | Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Change in Haemoglobin | Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Change in Pulse | Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented. | Week 0, week 104/premature treatment discontinuation |
| Haleyville |
| Alabama |
| 35565-1719 |
| United States |
| Novo Nordisk Investigational Site | Tuscumbia | Alabama | 35674 | United States |
| Novo Nordisk Investigational Site | Fountain Hills | Arizona | 85268 | United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85018 | United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85037 | United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85050 | United States |
| Novo Nordisk Investigational Site | Tempe | Arizona | 85283 | United States |
| Novo Nordisk Investigational Site | Tucson | Arizona | 85741 | United States |
| Novo Nordisk Investigational Site | Harrisburg | Arkansas | 72432-1132 | United States |
| Novo Nordisk Investigational Site | Little Rock | Arkansas | 72212 | United States |
| Novo Nordisk Investigational Site | North Little Rock | Arkansas | 72117 | United States |
| Novo Nordisk Investigational Site | Searcy | Arkansas | 72143 | United States |
| Novo Nordisk Investigational Site | Alhambra | California | 91801 | United States |
| Novo Nordisk Investigational Site | Buena Park | California | 90620 | United States |
| Novo Nordisk Investigational Site | Carlsbad | California | 92008 | United States |
| Novo Nordisk Investigational Site | Coronado | California | 92118 | United States |
| Novo Nordisk Investigational Site | Costa Mesa | California | 92627 | United States |
| Novo Nordisk Investigational Site | Elk Grove | California | 95758 | United States |
| Novo Nordisk Investigational Site | Encinitas | California | 92024 | United States |
| Novo Nordisk Investigational Site | Huntington Beach | California | 92646 | United States |
| Novo Nordisk Investigational Site | La Mirada | California | 90638 | United States |
| Novo Nordisk Investigational Site | Lancaster | California | 93534 | United States |
| Novo Nordisk Investigational Site | Lomita | California | 90717 | United States |
| Novo Nordisk Investigational Site | Montclair | California | 91763 | United States |
| Novo Nordisk Investigational Site | Northridge | California | 91325 | United States |
| Novo Nordisk Investigational Site | Oxnard | California | 93030 | United States |
| Novo Nordisk Investigational Site | Rancho Cucamonga | California | 91730-3063 | United States |
| Novo Nordisk Investigational Site | Riverside | California | 92506 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92111 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92120 | United States |
| Novo Nordisk Investigational Site | San Ramon | California | 94582 | United States |
| Novo Nordisk Investigational Site | Tustin | California | 92780 | United States |
| Novo Nordisk Investigational Site | Westminster | California | 92683 | United States |
| Novo Nordisk Investigational Site | Centennial | Colorado | 80012 | United States |
| Novo Nordisk Investigational Site | Centennial | Colorado | 80112 | United States |
| Novo Nordisk Investigational Site | Colorado Springs | Colorado | 80906 | United States |
| Novo Nordisk Investigational Site | Golden | Colorado | 80401 | United States |
| Novo Nordisk Investigational Site | Monument | Colorado | 80132 | United States |
| Novo Nordisk Investigational Site | Chiefland | Florida | 32626 | United States |
| Novo Nordisk Investigational Site | Clearwater | Florida | 33756 | United States |
| Novo Nordisk Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| Novo Nordisk Investigational Site | Hollywood | Florida | 33024 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32205 | United States |
| Novo Nordisk Investigational Site | Kissimmee | Florida | 34741 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33174 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33175 | United States |
| Novo Nordisk Investigational Site | Ocala | Florida | 34470 | United States |
| Novo Nordisk Investigational Site | Ocoee | Florida | 34761 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32819 | United States |
| Novo Nordisk Investigational Site | Ormond Beach | Florida | 32174-6302 | United States |
| Novo Nordisk Investigational Site | Oviedo | Florida | 32765 | United States |
| Novo Nordisk Investigational Site | Palm Harbor | Florida | 34684-3609 | United States |
| Novo Nordisk Investigational Site | Pembroke Pines | Florida | 33027 | United States |
| Novo Nordisk Investigational Site | Seminole | Florida | 33773 | United States |
| Novo Nordisk Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Novo Nordisk Investigational Site | Bainbridge | Georgia | 39819 | United States |
| Novo Nordisk Investigational Site | Conyers | Georgia | 30094-5965 | United States |
| Novo Nordisk Investigational Site | Perry | Georgia | 31069 | United States |
| Novo Nordisk Investigational Site | Statesboro | Georgia | 30461 | United States |
| Novo Nordisk Investigational Site | Suwanee | Georgia | 30024 | United States |
| Novo Nordisk Investigational Site | Woodstock | Georgia | 30189-4255 | United States |
| Novo Nordisk Investigational Site | Meridian | Idaho | 83646 | United States |
| Novo Nordisk Investigational Site | Aurora | Illinois | 60506 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60616 | United States |
| Novo Nordisk Investigational Site | Gillespie | Illinois | 62033 | United States |
| Novo Nordisk Investigational Site | Wauconda | Illinois | 60084 | United States |
| Novo Nordisk Investigational Site | Avon | Indiana | 46123 | United States |
| Novo Nordisk Investigational Site | Evansville | Indiana | 47714 | United States |
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| Novo Nordisk Investigational Site | Muncie | Indiana | 47304 | United States |
| Novo Nordisk Investigational Site | Newton | Kansas | 67114 | United States |
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| Novo Nordisk Investigational Site | Wichita | Kansas | 67205 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40503 | United States |
| Novo Nordisk Investigational Site | Natchitoches | Louisiana | 71457-5881 | United States |
| Novo Nordisk Investigational Site | Shreveport | Louisiana | 71105 | United States |
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| Novo Nordisk Investigational Site | Elkridge | Maryland | 21075-6437 | United States |
| Novo Nordisk Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| Novo Nordisk Investigational Site | Buckley | Michigan | 49620 | United States |
| Novo Nordisk Investigational Site | Rochester | Michigan | 48307 | United States |
| Novo Nordisk Investigational Site | Sterling Heights | Michigan | 48310-3503 | United States |
| Novo Nordisk Investigational Site | Troy | Michigan | 48098 | United States |
| Novo Nordisk Investigational Site | Belzoni | Mississippi | 39038 | United States |
| Novo Nordisk Investigational Site | Port Gibson | Mississippi | 39150 | United States |
| Novo Nordisk Investigational Site | Butte | Montana | 59701 | United States |
| Novo Nordisk Investigational Site | Missoula | Montana | 59808 | United States |
| Novo Nordisk Investigational Site | Fremont | Nebraska | 68025 | United States |
| Novo Nordisk Investigational Site | Omaha | Nebraska | 68144 | United States |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89118 | United States |
| Novo Nordisk Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Novo Nordisk Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Novo Nordisk Investigational Site | Brooklyn | New York | 11215 | United States |
| Novo Nordisk Investigational Site | New Windsor | New York | 12533 | United States |
| Novo Nordisk Investigational Site | North Massapequa | New York | 11758-1802 | United States |
| Novo Nordisk Investigational Site | Westfield | New York | 14787 | United States |
| Novo Nordisk Investigational Site | Asheboro | North Carolina | 27203 | United States |
| Novo Nordisk Investigational Site | Burlington | North Carolina | 27215 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28277-6594 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Novo Nordisk Investigational Site | Elizabeth City | North Carolina | 27909 | United States |
| Novo Nordisk Investigational Site | Garner | North Carolina | 27529 | United States |
| Novo Nordisk Investigational Site | Mooresville | North Carolina | 28117 | United States |
| Novo Nordisk Investigational Site | Morganton | North Carolina | 28655 | United States |
| Novo Nordisk Investigational Site | Whiteville | North Carolina | 28472 | United States |
| Novo Nordisk Investigational Site | Fargo | North Dakota | 58104 | United States |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43213 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45406 | United States |
| Novo Nordisk Investigational Site | Franklin | Ohio | 45005 | United States |
| Novo Nordisk Investigational Site | Mason | Ohio | 45040-6815 | United States |
| Novo Nordisk Investigational Site | Toledo | Ohio | 43623 | United States |
| Novo Nordisk Investigational Site | Wadsworth | Ohio | 44281 | United States |
| Novo Nordisk Investigational Site | Edmond | Oklahoma | 73034 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73162-4704 | United States |
| Novo Nordisk Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| Novo Nordisk Investigational Site | Fleetwood | Pennsylvania | 19522 | United States |
| Novo Nordisk Investigational Site | Harleysville | Pennsylvania | 19438 | United States |
| Novo Nordisk Investigational Site | Jersey Shore | Pennsylvania | 17740 | United States |
| Novo Nordisk Investigational Site | Lansdale | Pennsylvania | 19446-1002 | United States |
| Novo Nordisk Investigational Site | Levittown | Pennsylvania | 19056-2404 | United States |
| Novo Nordisk Investigational Site | Levittown | Pennsylvania | 19056 | United States |
| Novo Nordisk Investigational Site | McMurray | Pennsylvania | 15317 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19114 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15236 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Novo Nordisk Investigational Site | Smithfield | Pennsylvania | 15478 | United States |
| Novo Nordisk Investigational Site | Uniontown | Pennsylvania | 15401 | United States |
| Novo Nordisk Investigational Site | Providence | Rhode Island | 02908 | United States |
| Novo Nordisk Investigational Site | Anderson | South Carolina | 29621 | United States |
| Novo Nordisk Investigational Site | Columbia | South Carolina | 29223 | United States |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | United States |
| Novo Nordisk Investigational Site | Old Point Station | South Carolina | 29707 | United States |
| Novo Nordisk Investigational Site | Pelzer | South Carolina | 29669 | United States |
| Novo Nordisk Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| Novo Nordisk Investigational Site | Rapid City | South Dakota | 57702 | United States |
| Novo Nordisk Investigational Site | Athens | Tennessee | 37303 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Novo Nordisk Investigational Site | Humboldt | Tennessee | 38343 | United States |
| Novo Nordisk Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Novo Nordisk Investigational Site | Tullahoma | Tennessee | 37388 | United States |
| Novo Nordisk Investigational Site | Arlington | Texas | 76014-2010 | United States |
| Novo Nordisk Investigational Site | Arlington | Texas | 76015 | United States |
| Novo Nordisk Investigational Site | Carrollton | Texas | 75010 | United States |
| Novo Nordisk Investigational Site | Corpus Christi | Texas | 78404 | United States |
| Novo Nordisk Investigational Site | Corpus Christi | Texas | 78413 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75251 | United States |
| Novo Nordisk Investigational Site | Fort Worth | Texas | 76164 | United States |
| Novo Nordisk Investigational Site | Georgetown | Texas | 78626 | United States |
| Novo Nordisk Investigational Site | Gonzales | Texas | 78629 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77024 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77025-1669 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77061 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77074 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77079 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77081 | United States |
| Novo Nordisk Investigational Site | Irving | Texas | 75061-2210 | United States |
| Novo Nordisk Investigational Site | Kerrville | Texas | 78028 | United States |
| Novo Nordisk Investigational Site | Killeen | Texas | 76543 | United States |
| Novo Nordisk Investigational Site | Longview | Texas | 75605 | United States |
| Novo Nordisk Investigational Site | Missouri City | Texas | 77459 | United States |
| Novo Nordisk Investigational Site | New Braunfels | Texas | 78130 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78240 | United States |
| Novo Nordisk Investigational Site | Splendora | Texas | 77372 | United States |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77478 | United States |
| Novo Nordisk Investigational Site | Sugar Land | Texas | 77479 | United States |
| Novo Nordisk Investigational Site | Waco | Texas | 76710 | United States |
| Novo Nordisk Investigational Site | Bountiful | Utah | 84010 | United States |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | United States |
| Novo Nordisk Investigational Site | Danville | Virginia | 24541 | United States |
| Novo Nordisk Investigational Site | Gloucester Courthouse | Virginia | 23061 | United States |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23510-2015 | United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23219 | United States |
| Novo Nordisk Investigational Site | Virginia Beach | Virginia | 23454 | United States |
| Novo Nordisk Investigational Site | Bellevue | Washington | 98004-4604 | United States |
| Novo Nordisk Investigational Site | Spokane | Washington | 99216-1557 | United States |
| Novo Nordisk Investigational Site | Walla Walla | Washington | 99362-4445 | United States |
| Novo Nordisk Investigational Site | Surrey | British Columbia | V3Z 2N6 | Canada |
| Novo Nordisk Investigational Site | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| Novo Nordisk Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| Novo Nordisk Investigational Site | Hamilton | Ontario | L8M 1K7 | Canada |
| Novo Nordisk Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Novo Nordisk Investigational Site | Strathroy | Ontario | N7G 1Y7 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M3J 1N2 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M9V 4B4 | Canada |
| Novo Nordisk Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novo Nordisk Investigational Site | Montreal | Quebec | H4N 2W2 | Canada |
| Novo Nordisk Investigational Site | Saint-Marc-des-Carrieres | Quebec | G0A 4B0 | Canada |
| Novo Nordisk Investigational Site | Québec | G1G 3Y8 | Canada |
| Novo Nordisk Investigational Site | Bogotá | 110221 | Colombia |
| Novo Nordisk Investigational Site | Bogotá | 111211 | Colombia |
| Novo Nordisk Investigational Site | Medellín | Colombia |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560 017 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560002 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560054 | India |
| Novo Nordisk Investigational Site | Mysore | Karnataka | 570001 | India |
| Novo Nordisk Investigational Site | Indore | Madhya Pradesh | 452008 | India |
| Novo Nordisk Investigational Site | Nagpur | Maharashtra | 440003 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411001 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411004 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411013 | India |
| Novo Nordisk Investigational Site | Hyderabad | Telangana | 500033 | India |
| Novo Nordisk Investigational Site | Lucknow | Uttar Pradesh | 226005 | India |
| Novo Nordisk Investigational Site | Noida | Uttar Pradesh | 201301 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700027 | India |
| Novo Nordisk Investigational Site | Kolkata | West Bengal | 700054 | India |
| Novo Nordisk Investigational Site | Hubli | 580022 | India |
| Novo Nordisk Investigational Site | Ludhiana | 141001 | India |
| Novo Nordisk Investigational Site | Riga | LV1011 | Latvia |
| Novo Nordisk Investigational Site | Riga | LV1057 | Latvia |
| Novo Nordisk Investigational Site | Tukums | LV3101 | Latvia |
| Novo Nordisk Investigational Site | Beirut | Lebanon |
| Novo Nordisk Investigational Site | Byblos | Lebanon |
| Novo Nordisk Investigational Site | El Achrafiyé | Lebanon |
| Novo Nordisk Investigational Site | Hazmiyeh | Lebanon |
| Novo Nordisk Investigational Site | Toa Baja | 00949 | Puerto Rico |
| Novo Nordisk Investigational Site | Trujillo Alto | 00976 | Puerto Rico |
| Novo Nordisk Investigational Site | Dzerzhinskiy | 140091 | Russia |
| Novo Nordisk Investigational Site | Moscow | 101990 | Russia |
| Novo Nordisk Investigational Site | Moscow | 121293 | Russia |
| Novo Nordisk Investigational Site | Moscow | 125315 | Russia |
| Novo Nordisk Investigational Site | Saint Petersburg | 197762 | Russia |
| Novo Nordisk Investigational Site | Belgrade | 11000 | Serbia |
| Novo Nordisk Investigational Site | Kragujevac | 34000 | Serbia |
| Novo Nordisk Investigational Site | Niš | 18000 | Serbia |
| Novo Nordisk Investigational Site | Novi Sad | 21000 | Serbia |
| Novo Nordisk Investigational Site | Adapazarı | 54290 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34130 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34722 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34890 | Turkey (Türkiye) |
| Derived |
| 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. |
| Oral Antidiabetic Drug |
Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
| Treated |
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| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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FAS included all randomised participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide 1.8 mg | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. |
| BG001 | Oral Antidiabetic Drug | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Posted | Median | Inter-Quartile Range | Weeks | Weeks 26-104 |
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| Secondary | 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. | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Posted | Median | Inter-Quartile Range | Weeks | Weeks 0-104 |
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| Secondary | Change in HbA1c | Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Percentage point of HbA1c | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Participants who achieved HbA1c ≤6.5% (yes/no) is presented. | FAS included all randomised participants. | Posted | Count of Participants | Participants | Week 104/Premature treatment discontinuation |
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| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented. | FAS included all randomised participants. | Posted | Count of Participants | Participants | Week 104/Premature treatment discontinuation |
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| Secondary | 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. | FAS included all randomised participants. | Posted | Count of Participants | Participants | Week 104/Premature treatment discontinuation |
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| Secondary | 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. | FAS included all randomised participants. | Posted | Count of Participants | Participants | Week 104/Premature treatment discontinuation |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Change in Body Weight | Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Kilogram (Kg) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Change in Body Mass Index (BMI) | Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Kilograms per square meter (kg/m^2) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | 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. | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | 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. | Safety analysis set (SAS) included all participants exposed to at least one dose of trial product. | Posted | Number | Episodes | Weeks 0-104 |
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| Secondary | 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. | SAS included all participants exposed to at least one dose of trial product. | Posted | Number | Episodes | Weeks 0-104 |
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| Secondary | 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. | SAS included all participants exposed to at least one dose of trial product. | Posted | Number | Episodes | Weeks 0-104 |
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| Secondary | 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. | SAS included all participants exposed to at least one dose of trial product. | Posted | Number | Events | Weeks 0-105 |
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| Secondary | 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. | SAS included all participants exposed to at least one dose of trial product. | Posted | Number | Events | Weeks 0-105 |
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| Secondary | 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. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | 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. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Units per liter (U/L) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | 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. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | 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). | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | mL/min/SSA | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Change in Potassium | Change from baseline (week 0) in potassium at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Change in Haemoglobin | Change from baseline (week 0) in haemoglobin at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Grams per deciliter (g/dL) | Week 0, week 104/premature treatment discontinuation |
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| Secondary | Change in Pulse | Change from baseline (week 0) in pulse at week 104 or at premature treatment discontinuation is presented. | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Posted | Mean | Standard Deviation | Beats per minute (beats/min) | Week 0, week 104/premature treatment discontinuation |
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|
Weeks 0-105
All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product administration. Results are based on the SAS which included all participants exposed to at least one dose of trial product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide 1.8 mg | Participants were to receive a subcutaneous injection of liraglutide once daily. Participants received 0.6 milligrams (mg) liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until the dose of 1.8 mg was reached. The treatment period was 104 weeks. | 1 | 980 | 92 | 980 | 65 | 980 |
| EG001 | Oral Antidiabetic Drug | Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks. | 8 | 984 | 81 | 984 | 15 | 984 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Arrhythmia supraventricular | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Arterial bypass occlusion | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA 22 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Delusional disorder, unspecified type | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 22 | Systematic Assessment |
| |
| Empty sella syndrome | Endocrine disorders | MedDRA 22 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 22 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Exophthalmos | Eye disorders | MedDRA 22 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Gastrectomy | Surgical and medical procedures | MedDRA 22 | Systematic Assessment |
| |
| Gastric bypass | Surgical and medical procedures | MedDRA 22 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 22 | Systematic Assessment |
| |
| Hepatosplenomegaly | Hepatobiliary disorders | MedDRA 22 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 22 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Intervertebral disc displacement | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 22 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 22 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Metabolic surgery | Surgical and medical procedures | MedDRA 22 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 22 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 22 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 22 | Systematic Assessment |
| |
| Pleural mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA 22 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 22 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Rectosigmoid cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
| |
| Spinal cord haematoma | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Spinal laminectomy | Surgical and medical procedures | MedDRA 22 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22 | Systematic Assessment |
| |
| Triple negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 22 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 22 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 22 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 22 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2020 | Jun 16, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D065089 | Glycoside Hydrolase Inhibitors |
| D054873 | Dipeptidyl-Peptidase IV Inhibitors |
| C030516 | meglitinide |
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| D013453 | Sulfonylurea Compounds |
| D045162 | Thiazolidinediones |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| D011480 | Protease Inhibitors |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
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Participants were to receive one selected OAD. The following OADs were allowed: alpha-glucosidase inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas or thiazolidinediones. The treatment period was 104 weeks.
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