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

Diabetes Mellitus, Type 2 Clinical Trial

— LIRA-PRIME  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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

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