Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730377
Other study ID # NN2211-4232
Secondary ID 2015-002417-29U1
Status Completed
Phase Phase 4
First received
Last updated
Start date March 28, 2016
Est. completion date August 12, 2019

Study information

Verified date June 2020
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 1991
Est. completion date August 12, 2019
Est. primary completion date August 5, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
liraglutide
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
alpha-glucosidase inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
DPP-4 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
meglitinides
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
SGLT-2 inhibitors
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
sulphonylurea
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
thiazolidinediones
Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.

Locations

Country Name City State
Canada Novo Nordisk Investigational Site Hamilton Ontario
Canada Novo Nordisk Investigational Site Montreal Quebec
Canada Novo Nordisk Investigational Site Mount Pearl Newfoundland and Labrador
Canada Novo Nordisk Investigational Site Quebec
Canada Novo Nordisk Investigational Site Sarnia Ontario
Canada Novo Nordisk Investigational Site St-Marc-des-Carrières Quebec
Canada Novo Nordisk Investigational Site Strathroy Ontario
Canada Novo Nordisk Investigational Site Surrey British Columbia
Canada Novo Nordisk Investigational Site Toronto Ontario
Canada Novo Nordisk Investigational Site Toronto Ontario
Canada Novo Nordisk Investigational Site Truro Nova Scotia
Canada Novo Nordisk Investigational Site Waterloo Ontario
Colombia Novo Nordisk Investigational Site Bogota
Colombia Novo Nordisk Investigational Site Bogota
Colombia Novo Nordisk Investigational Site Medellin
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Bangalore Karnataka
India Novo Nordisk Investigational Site Hubli
India Novo Nordisk Investigational Site Hyderabad Telengana
India Novo Nordisk Investigational Site Indore Madhya Pradesh
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Kolkata West Bengal
India Novo Nordisk Investigational Site Lucknow Uttar Pradesh
India Novo Nordisk Investigational Site Ludhiana
India Novo Nordisk Investigational Site Mysore Karnataka
India Novo Nordisk Investigational Site Nagpur Maharashtra
India Novo Nordisk Investigational Site Noida Uttar Pradesh
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Pune Maharashtra
India Novo Nordisk Investigational Site Pune Maharashtra
Latvia Novo Nordisk Investigational Site Riga
Latvia Novo Nordisk Investigational Site Riga
Latvia Novo Nordisk Investigational Site Tukums
Lebanon Novo Nordisk Investigational Site Achrafieh
Lebanon Novo Nordisk Investigational Site Beirut
Lebanon Novo Nordisk Investigational Site Hazmieh
Lebanon Novo Nordisk Investigational Site Jbeil
Puerto Rico Novo Nordisk Investigational Site Toa Baja
Puerto Rico Novo Nordisk Investigational Site Trujillo Alto
Russian Federation Novo Nordisk Investigational Site Dzerzhinskiy
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Saint-Petersburg
Serbia Novo Nordisk Investigational Site Belgrade
Serbia Novo Nordisk Investigational Site Kragujevac
Serbia Novo Nordisk Investigational Site Nis
Serbia Novo Nordisk Investigational Site Novi Sad
Turkey Novo Nordisk Investigational Site Adapazari
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
Turkey Novo Nordisk Investigational Site Istanbul
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Alhambra California
United States Novo Nordisk Investigational Site Anderson South Carolina
United States Novo Nordisk Investigational Site Arlington Texas
United States Novo Nordisk Investigational Site Arlington Texas
United States Novo Nordisk Investigational Site Asheboro North Carolina
United States Novo Nordisk Investigational Site Athens Tennessee
United States Novo Nordisk Investigational Site Aurora Illinois
United States Novo Nordisk Investigational Site Avon Indiana
United States Novo Nordisk Investigational Site Bainbridge Georgia
United States Novo Nordisk Investigational Site Beaver Pennsylvania
United States Novo Nordisk Investigational Site Bellevue Washington
United States Novo Nordisk Investigational Site Belzoni Mississippi
United States Novo Nordisk Investigational Site Birmingham Alabama
United States Novo Nordisk Investigational Site Bountiful Utah
United States Novo Nordisk Investigational Site Brooklyn New York
United States Novo Nordisk Investigational Site Buckley Michigan
United States Novo Nordisk Investigational Site Buena Park California
United States Novo Nordisk Investigational Site Burlington North Carolina
United States Novo Nordisk Investigational Site Butte Montana
United States Novo Nordisk Investigational Site Carlsbad California
United States Novo Nordisk Investigational Site Carrollton Texas
United States Novo Nordisk Investigational Site Centennial Colorado
United States Novo Nordisk Investigational Site Centennial Colorado
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Chattanooga Tennessee
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Chiefland Florida
United States Novo Nordisk Investigational Site Clearwater Florida
United States Novo Nordisk Investigational Site Colorado Springs Colorado
United States Novo Nordisk Investigational Site Columbia South Carolina
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Conyers Georgia
United States Novo Nordisk Investigational Site Coronado California
United States Novo Nordisk Investigational Site Corpus Christi Texas
United States Novo Nordisk Investigational Site Corpus Christi Texas
United States Novo Nordisk Investigational Site Costa Mesa California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Danville Virginia
United States Novo Nordisk Investigational Site Dayton Ohio
United States Novo Nordisk Investigational Site Edmond Oklahoma
United States Novo Nordisk Investigational Site Elizabeth City North Carolina
United States Novo Nordisk Investigational Site Elk Grove California
United States Novo Nordisk Investigational Site Elkridge Maryland
United States Novo Nordisk Investigational Site Encinitas California
United States Novo Nordisk Investigational Site Evansville Indiana
United States Novo Nordisk Investigational Site Fargo North Dakota
United States Novo Nordisk Investigational Site Fleetwood Pennsylvania
United States Novo Nordisk Investigational Site Fort Lauderdale Florida
United States Novo Nordisk Investigational Site Fort Worth Texas
United States Novo Nordisk Investigational Site Fountain Hills Arizona
United States Novo Nordisk Investigational Site Franklin Ohio
United States Novo Nordisk Investigational Site Fremont Nebraska
United States Novo Nordisk Investigational Site Garner North Carolina
United States Novo Nordisk Investigational Site Georgetown Texas
United States Novo Nordisk Investigational Site Gillespie Illinois
United States Novo Nordisk Investigational Site Gloucester Courthouse Virginia
United States Novo Nordisk Investigational Site Golden Colorado
United States Novo Nordisk Investigational Site Gonzales Texas
United States Novo Nordisk Investigational Site Greenfield Indiana
United States Novo Nordisk Investigational Site Greer South Carolina
United States Novo Nordisk Investigational Site Haleyville Alabama
United States Novo Nordisk Investigational Site Harleysville Pennsylvania
United States Novo Nordisk Investigational Site Harrisburg Arkansas
United States Novo Nordisk Investigational Site Hollywood Florida
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Humboldt Tennessee
United States Novo Nordisk Investigational Site Huntington Beach California
United States Novo Nordisk Investigational Site Indian Land South Carolina
United States Novo Nordisk Investigational Site Irving Texas
United States Novo Nordisk Investigational Site Jacksonville Florida
United States Novo Nordisk Investigational Site Jersey Shore Pennsylvania
United States Novo Nordisk Investigational Site Kerrville Texas
United States Novo Nordisk Investigational Site Killeen Texas
United States Novo Nordisk Investigational Site Kingsport Tennessee
United States Novo Nordisk Investigational Site Kissimmee Florida
United States Novo Nordisk Investigational Site La Mirada California
United States Novo Nordisk Investigational Site Lancaster California
United States Novo Nordisk Investigational Site Lansdale Pennsylvania
United States Novo Nordisk Investigational Site Las Vegas Nevada
United States Novo Nordisk Investigational Site Levittown Pennsylvania
United States Novo Nordisk Investigational Site Levittown Pennsylvania
United States Novo Nordisk Investigational Site Lexington Kentucky
United States Novo Nordisk Investigational Site Little Rock Arkansas
United States Novo Nordisk Investigational Site Lomita California
United States Novo Nordisk Investigational Site Longview Texas
United States Novo Nordisk Investigational Site Mason Ohio
United States Novo Nordisk Investigational Site McMurray Pennsylvania
United States Novo Nordisk Investigational Site Meridian Idaho
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site Missoula Montana
United States Novo Nordisk Investigational Site Missouri City Texas
United States Novo Nordisk Investigational Site Montclair California
United States Novo Nordisk Investigational Site Monument Colorado
United States Novo Nordisk Investigational Site Mooresville North Carolina
United States Novo Nordisk Investigational Site Morganton North Carolina
United States Novo Nordisk Investigational Site Muncie Indiana
United States Novo Nordisk Investigational Site Natchitoches Louisiana
United States Novo Nordisk Investigational Site New Braunfels Texas
United States Novo Nordisk Investigational Site New Windsor New York
United States Novo Nordisk Investigational Site Newton Kansas
United States Novo Nordisk Investigational Site Norfolk Virginia
United States Novo Nordisk Investigational Site North Little Rock Arkansas
United States Novo Nordisk Investigational Site North Massapequa New York
United States Novo Nordisk Investigational Site Northridge California
United States Novo Nordisk Investigational Site Ocala Florida
United States Novo Nordisk Investigational Site Ocoee Florida
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Omaha Nebraska
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Ormond Beach Florida
United States Novo Nordisk Investigational Site Oviedo Florida
United States Novo Nordisk Investigational Site Oxnard California
United States Novo Nordisk Investigational Site Oxon Hill Maryland
United States Novo Nordisk Investigational Site Palm Harbor Florida
United States Novo Nordisk Investigational Site Park City Kansas
United States Novo Nordisk Investigational Site Pelzer South Carolina
United States Novo Nordisk Investigational Site Pembroke Pines Florida
United States Novo Nordisk Investigational Site Perry Georgia
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Port Gibson Mississippi
United States Novo Nordisk Investigational Site Providence Rhode Island
United States Novo Nordisk Investigational Site Rancho Cucamonga California
United States Novo Nordisk Investigational Site Rapid City South Dakota
United States Novo Nordisk Investigational Site Richmond Virginia
United States Novo Nordisk Investigational Site Riverside California
United States Novo Nordisk Investigational Site Rochester Michigan
United States Novo Nordisk Investigational Site Saint George Utah
United States Novo Nordisk Investigational Site Saint Petersburg Florida
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site San Ramon California
United States Novo Nordisk Investigational Site Searcy Arkansas
United States Novo Nordisk Investigational Site Seminole Florida
United States Novo Nordisk Investigational Site Shreveport Louisiana
United States Novo Nordisk Investigational Site Simpsonville South Carolina
United States Novo Nordisk Investigational Site Smithfield Pennsylvania
United States Novo Nordisk Investigational Site Splendora Texas
United States Novo Nordisk Investigational Site Spokane Washington
United States Novo Nordisk Investigational Site Statesboro Georgia
United States Novo Nordisk Investigational Site Sterling Heights Michigan
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Sunset Louisiana
United States Novo Nordisk Investigational Site Suwanee Georgia
United States Novo Nordisk Investigational Site Tempe Arizona
United States Novo Nordisk Investigational Site Toledo Ohio
United States Novo Nordisk Investigational Site Troy Michigan
United States Novo Nordisk Investigational Site Tucson Arizona
United States Novo Nordisk Investigational Site Tullahoma Tennessee
United States Novo Nordisk Investigational Site Tuscumbia Alabama
United States Novo Nordisk Investigational Site Tustin California
United States Novo Nordisk Investigational Site Uniontown Pennsylvania
United States Novo Nordisk Investigational Site Virginia Beach Virginia
United States Novo Nordisk Investigational Site Waco Texas
United States Novo Nordisk Investigational Site Wadsworth Ohio
United States Novo Nordisk Investigational Site Walla Walla Washington
United States Novo Nordisk Investigational Site Wauconda Illinois
United States Novo Nordisk Investigational Site Westfield New York
United States Novo Nordisk Investigational Site Westminster California
United States Novo Nordisk Investigational Site Whiteville North Carolina
United States Novo Nordisk Investigational Site Wichita Kansas
United States Novo Nordisk Investigational Site Woodstock Georgia

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  India,  Latvia,  Lebanon,  Puerto Rico,  Russian Federation,  Serbia,  Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Weeks 26-104
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. Weeks 0-104
Secondary 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
Secondary Participants Who Achieve HbA1c =6.5% (Yes/No) Participants who achieved HbA1c =6.5% (yes/no) is presented. Week 104/Premature treatment discontinuation
Secondary 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
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. Week 104/Premature treatment discontinuation
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. Week 104/Premature treatment discontinuation
Secondary 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
Secondary 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
Secondary 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
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. Week 0, week 104/premature treatment discontinuation
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. Weeks 0-104
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. Weeks 0-104
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. Weeks 0-104
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. Weeks 0-105
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. Weeks 0-105
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. Week 0, week 104/premature treatment discontinuation
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. Week 0, week 104/premature treatment discontinuation
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. Week 0, week 104/premature treatment discontinuation
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). Week 0, week 104/premature treatment discontinuation
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2