A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SUSTAIN 11  

Official title:

Effect of Semaglutide Once-weekly Versus Insulin Aspart Three Times Daily, Both as Add on to Metformin and Optimised Insulin Glargine (U100) in Subjects With Type 2 Diabetes A 52-week, Multi-centre, Multinational, Open-label, Active-controlled, Two Armed, Parallel-group, Randomised Trial in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689374
• Other study ID #: NN9535-4386
• Secondary ID: U1111-1200-01642
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: February 22, 2021

Study information

• Verified date: November 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the effect of semaglutide once weekly to insulin aspart 3 times daily as add on to metformin and insulin glargine in people with type 2 diabetes. Participants will either get insulin glargine and semaglutide or insulin glargine and insulin aspart - which treatment the participant get is decided by chance. Insulin glargine is taken once a day and semaglutide once a week. Insulin aspart is taken three times per day before a meal. All three medicines come in pre-filled pens for injection under the skin. The study will last for about 71 weeks. If participant's blood sugar gets under or over certain values participant will only participate in 14 weeks. The study doctor will inform the participant about this. The participant will have 15 clinic visits and 22 phone calls with the study doctor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2274
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, age greater than or equal to 18 years at the time of signing informed consent

• Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening

• Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening

• Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors

• Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)

Exclusion Criteria:

• History or presence of pancreatitis (acute or chronic)

• Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening

• Subjects presently classified as being in New York Heart Association Class IV

• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.
• Insulin aspart
Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days
• Insulin glargine U100
Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)

Locations

Country	Name	City	State
Bosnia and Herzegovina	Novo Nordisk Investigational Site	Banja Luka
Bosnia and Herzegovina	Novo Nordisk Investigational Site	Sarajevo
Bosnia and Herzegovina	Novo Nordisk Investigational Site	Tuzla
Bulgaria	Novo Nordisk Investigational Site	Burgas
Bulgaria	Novo Nordisk Investigational Site	Byala
Bulgaria	Novo Nordisk Investigational Site	Dimitrovgrad
Bulgaria	Novo Nordisk Investigational Site	Plovdiv
Bulgaria	Novo Nordisk Investigational Site	Ruse
Bulgaria	Novo Nordisk Investigational Site	Sofia
Bulgaria	Novo Nordisk Investigational Site	Stara Zagora
Bulgaria	Novo Nordisk Investigational Site	Stara Zagora
Bulgaria	Novo Nordisk Investigational Site	Varna
Croatia	Novo Nordisk Investigational Site	Karlovac
Croatia	Novo Nordisk Investigational Site	Osijek
Croatia	Novo Nordisk Investigational Site	Pula
Croatia	Novo Nordisk Investigational Site	Rijeka
Croatia	Novo Nordisk Investigational Site	Varazdin
Croatia	Novo Nordisk Investigational Site	Zagreb
Czechia	Novo Nordisk Investigational Site	Beroun
Czechia	Novo Nordisk Investigational Site	Brno
Czechia	Novo Nordisk Investigational Site	Kladno - Krocehlavy
Czechia	Novo Nordisk Investigational Site	Mlada Boleslav
Czechia	Novo Nordisk Investigational Site	Nachod
Czechia	Novo Nordisk Investigational Site	Olomouc
Czechia	Novo Nordisk Investigational Site	Plzen
Czechia	Novo Nordisk Investigational Site	Prostejov
Estonia	Novo Nordisk Investigational Site	Pärnu
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Viljandi
Germany	Novo Nordisk Investigational Site	Bad Kreuznach
Germany	Novo Nordisk Investigational Site	Bad Mergentheim
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Eisenach
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Esslingen
Germany	Novo Nordisk Investigational Site	Falkensee
Germany	Novo Nordisk Investigational Site	Friedrichsthal
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Hohenmölsen
Germany	Novo Nordisk Investigational Site	Jerichow
Germany	Novo Nordisk Investigational Site	Kiel Kronshagen
Germany	Novo Nordisk Investigational Site	Leipzig
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Münster
Germany	Novo Nordisk Investigational Site	Oldenburg I. Holst
Germany	Novo Nordisk Investigational Site	Pohlheim
Germany	Novo Nordisk Investigational Site	Rehlingen-Siersburg
Germany	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach
Germany	Novo Nordisk Investigational Site	Schwabenheim
Germany	Novo Nordisk Investigational Site	Schweinfurt
Germany	Novo Nordisk Investigational Site	Stuhr
Germany	Novo Nordisk Investigational Site	Stuttgart
Germany	Novo Nordisk Investigational Site	Stuttgart
Germany	Novo Nordisk Investigational Site	Villingen-Schwenningen
Greece	Novo Nordisk Investigational Site	Alexandroupolis
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Larissa
Greece	Novo Nordisk Investigational Site	Piraeus
Greece	Novo Nordisk Investigational Site	Thessaloniki
Greece	Novo Nordisk Investigational Site	Thessaloniki
Greece	Novo Nordisk Investigational Site	Thessaloniki
Greece	Novo Nordisk Investigational Site	Thessaloniki
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Gyula
Hungary	Novo Nordisk Investigational Site	Nagykanizsa
Hungary	Novo Nordisk Investigational Site	Pécs
Hungary	Novo Nordisk Investigational Site	Salgótarján
Hungary	Novo Nordisk Investigational Site	Szeged
Hungary	Novo Nordisk Investigational Site	Zalaegerszeg
India	Novo Nordisk Investigational Site	Ahmedabad	Gujarat
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bhubaneswar	Orissa
India	Novo Nordisk Investigational Site	Bhubaneswar	Orissa
India	Novo Nordisk Investigational Site	Chandigarh	Punjab
India	Novo Nordisk Investigational Site	Delhi	New Delhi
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Hyderabad	Telengana
India	Novo Nordisk Investigational Site	Hyderbad	Telengana
India	Novo Nordisk Investigational Site	Indore	Madhya Pradesh
India	Novo Nordisk Investigational Site	Jaipur	Rajasthan
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
India	Novo Nordisk Investigational Site	Ludhiana	Punjab
India	Novo Nordisk Investigational Site	Madurai	Tamil Nadu
India	Novo Nordisk Investigational Site	Mohali	Punjab
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	Nagpur	Maharashtra
India	Novo Nordisk Investigational Site	New Dehli	New Delhi
India	Novo Nordisk Investigational Site	New Delhi
India	Novo Nordisk Investigational Site	Pune	Maharashtra
Latvia	Novo Nordisk Investigational Site	Jelgava
Latvia	Novo Nordisk Investigational Site	Ogre
Latvia	Novo Nordisk Investigational Site	Riga
Latvia	Novo Nordisk Investigational Site	Riga
Latvia	Novo Nordisk Investigational Site	Sigulda
Latvia	Novo Nordisk Investigational Site	Talsi
Lithuania	Novo Nordisk Investigational Site	Kaunas
Lithuania	Novo Nordisk Investigational Site	Kaunas
Lithuania	Novo Nordisk Investigational Site	Kaunas
Lithuania	Novo Nordisk Investigational Site	Panevezys
Lithuania	Novo Nordisk Investigational Site	Vilnius
Lithuania	Novo Nordisk Investigational Site	Vilnius
North Macedonia	Novo Nordisk Investigational Site	Skopje
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Gorzow Wielkopolski
Poland	Novo Nordisk Investigational Site	Lodz
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Poznan
Poland	Novo Nordisk Investigational Site	Pulawy
Poland	Novo Nordisk Investigational Site	Ruda Slaska
Poland	Novo Nordisk Investigational Site	Siedlce
Poland	Novo Nordisk Investigational Site	Skorzewo
Poland	Novo Nordisk Investigational Site	Warsaw
Poland	Novo Nordisk Investigational Site	Wierzchoslawice
Poland	Novo Nordisk Investigational Site	Wroclaw
Poland	Novo Nordisk Investigational Site	Wroclaw
Poland	Novo Nordisk Investigational Site	Zabrze
Portugal	Novo Nordisk Investigational Site	Almada
Portugal	Novo Nordisk Investigational Site	Braga
Portugal	Novo Nordisk Investigational Site	Coimbra
Portugal	Novo Nordisk Investigational Site	Lisboa
Portugal	Novo Nordisk Investigational Site	Loures
Portugal	Novo Nordisk Investigational Site	Porto
Portugal	Novo Nordisk Investigational Site	Setubal
Romania	Novo Nordisk Investigational Site	Brasov
Romania	Novo Nordisk Investigational Site	Brasov
Romania	Novo Nordisk Investigational Site	Cluj Napoca	Cluj
Romania	Novo Nordisk Investigational Site	Galati
Romania	Novo Nordisk Investigational Site	Ploiesti	Prahova
Romania	Novo Nordisk Investigational Site	Targoviste	Dambovita
Romania	Novo Nordisk Investigational Site	Targu Mures	Mures
Serbia	Novo Nordisk Investigational Site	Belgrade
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
Serbia	Novo Nordisk Investigational Site	Zajecar
Slovakia	Novo Nordisk Investigational Site	Bardejov
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Bratislava
Slovakia	Novo Nordisk Investigational Site	Dolny Kubin
Slovakia	Novo Nordisk Investigational Site	Levice
Slovakia	Novo Nordisk Investigational Site	Lubochna
Slovakia	Novo Nordisk Investigational Site	Martin
Slovakia	Novo Nordisk Investigational Site	Presov
Slovakia	Novo Nordisk Investigational Site	Prievidza
Slovakia	Novo Nordisk Investigational Site	Sabinov
Slovenia	Novo Nordisk Investigational Site	Brezice
Slovenia	Novo Nordisk Investigational Site	Jesenice
Slovenia	Novo Nordisk Investigational Site	Koper
Slovenia	Novo Nordisk Investigational Site	Murska Sobota
Slovenia	Novo Nordisk Investigational Site	Nova Gorica
Slovenia	Novo Nordisk Investigational Site	Nova Gorica
South Africa	Novo Nordisk Investigational Site	Benoni	Gauteng
South Africa	Novo Nordisk Investigational Site	Cosmo City	Gauteng
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Lenasia	Gauteng
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
South Africa	Novo Nordisk Investigational Site	Umkomaas	KwaZulu-Natal
Spain	Novo Nordisk Investigational Site	Almeria
Spain	Novo Nordisk Investigational Site	Antequera
Spain	Novo Nordisk Investigational Site	Córdoba
Spain	Novo Nordisk Investigational Site	Fuenlabrada - Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Málaga
Spain	Novo Nordisk Investigational Site	Palma de Mallorca
Spain	Novo Nordisk Investigational Site	Segovia
Spain	Novo Nordisk Investigational Site	Sevilla
Turkey	Novo Nordisk Investigational Site	Adana
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Antalya
Turkey	Novo Nordisk Investigational Site	Denizli
Turkey	Novo Nordisk Investigational Site	Erzurum
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Izmir
Turkey	Novo Nordisk Investigational Site	Izmir
Turkey	Novo Nordisk Investigational Site	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Bulgaria,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Hungary,  India,  Latvia,  Lithuania,  North Macedonia,  Poland,  Portugal,  Romania,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Turkey, 

References & Publications (1)

Kellerer M, Kaltoft MS, Lawson J, Nielsen LL, Strojek K, Tabak Ö, Jacob S. Effect of once-weekly semaglutide versus thrice-daily insulin aspart, both as add-on to metformin and optimized insulin glargine treatment in participants with type 2 diabetes (SUS — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycated Haemoglobin (HbA1c)	Change from baseline in HbA1c at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with plasma glucose (PG) less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligrams per deciliter (mg/dL)). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) up to week 52
Secondary	Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52	First event per 100 years of exposure time for first EAC confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) up to week 52
Secondary	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52	Number of EAC-confirmed severe hypoglycaemic episodes from randomization (week 0) up to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). EAC confirmed-severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <3.1 mmol/L (56 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode, that was BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52	Number of EAC-confirmed severe or BG confirmed, symptomatic hypoglycaemic episodes (PG <=3.9 mmol/L (70 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe or BG confirmed symptomatic hypoglycaemia was an episode during which symptoms of hypoglycaemia were not accompanied by a PG determination but that was presumably caused by a PG concentration <= 3.9 mmol/L (70 mg/dL). Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Secondary	Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52	Number of EAC-confirmed severe hypoglycaemic episodes requiring hospitalization, documented medical help, or is life-threatening from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Secondary	Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52	Number of EAC-confirmed severe or clinically significant hypoglycaemic episodes (plasma glucose < 3.0 mmol/L (54 mg/dL)) from randomization (week 0) to week 52 are presented. As per 2013 ADA criteria severe hypoglycaemic episodes were episodes with PG <=3.9 mmol/L (70 mg/dL). Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions. Hypoglycaemic episode with plasma glucose < 3.0 mmol/L (54 mg/dL)) was considered as clinically significant. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	From randomization (week 0) to week 52
Secondary	Daily Basal Insulin Dose at Week 52	Daily basal insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	At week 52
Secondary	Total Daily Insulin Dose at Week 52	Total daily insulin dose at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	At week 52
Secondary	Change From Baseline to Week 52 in Body Weight (Kilogram (kg))	Change from baseline in body weight at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG)	Change from baseline in FPG at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP)	Change from baseline in 7-point self-measured plasma glucose profile: mean 7-PP at week 52 is presented. All participants were instructed to perform 7-point SMPG profiles before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal (dinner), 90 minutes after the start of main evening meal (dinner) and at bedtime. The measurements were to be performed before any injection of bolus insulin and just before the start of the meal (breakfast, lunch or main evening meal), and values measured before breakfast were performed in a fasting condition. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals)	Change from baseline in 7-point SMPG profile: mean post-prandial increment (over all meals) at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Body Mass Index (BMI)	Change from baseline in BMI at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Waist Circumference	Change from baseline in waist circumference at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline	Change from baseline in body weight (measured in percentage) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline)	Change from baseline in total cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)	Change from baseline in LDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)	Change from baseline in HDL cholesterol (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Fasting Blood Lipids: Triglycerides (Ratio to Baseline)	Change from baseline in triglycerides (measured in mmol/L) at week 52 is presented as ratio to baseline. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Systolic and Diastolic Blood Pressure	Change from baseline in systolic and diastolic blood pressure at week 52 are presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Pulse Rate	Change from baseline in pulse rate at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in 36-item Short Form Health Survey Version 2 (SF-36v2): Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains	SF-36v2 is 36-item patient-reported survey of patient health to measure participant's overall health-related quality of life (HRQoL). It has 36 items: 8 domains of physical, mental health status (physical functioning, role physical health (range:21.23-57.16), bodily pain (range: 21.68-62.00), general health (range: 18.95-66.50), vitality (range: 22.89-70.42), social functioning (range: 17.23-57.34), role emotional problem (range: 14.39-56.17) and mental health (range: 11.63-63.95)) and 2 total summary scores: physical components summary (range: 7.32-70.14) and mental components summary (range: 5.79-69.91) calculated from domain scores. All 10 scores range from 5.79-70.42 . Higher scores indicated a better health state. Change from baseline in SF-36v2, 2 summary and 8 domains scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from date of first dose of trial product (week 0) to last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52
Secondary	Change From Baseline to Week 52 in Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ-R): Scores From the 8 Domains	The DQLCTQ-R questionnaire was used to assess participants' HRQoL. The DQLCTQ-R questionnaire contains 57 items and measures and provide scores for the 8 domains (physical function, energy or fatigue, health distress, mental health, satisfaction, treatment satisfaction, treatment flexibility and frequency of symptoms). The 8 domain scores related to DQLCTQ-R are measured on a scale from 0-100. For all scores, higher values indicated better health status. Change from baseline in DQLCTQ-R 8 domain scores at week 52 is presented. Data is reported for 'on-treatment' observation period: from the date of first dose of trial product (week 0) to the last date on trial product with a visit window of +7 days (week 52).	Baseline (week 0), week 52