A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Diabetes Mellitus, Type 2 Clinical Trial

— CONCLUDE  

Official title:

A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078478
• Other study ID #: NN1250-4252
• Secondary ID: U1111-1184-81752
• Status: Completed
• Phase: Phase 3
• Start date: March 13, 2017
• Est. completion date: March 4, 2019

Study information

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

Clinical Trial Summary

This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1609
• Est. completion date: March 4, 2019
• Est. primary completion date: February 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Subjects fulfilling at least one of the below criteria (For this inclusion criterion the aim is to include minimum 80% of individuals with a previous episode of hypoglycaemia (criterion e). The remaining subjects will have to fulfil at least one of criteria a-d.): - a) Experienced at least one severe hypoglycaemic episode within the last year (according to the ADA definition, April 2013 (An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.). - b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-EPI by central laboratory analysis. - c) Hypoglycaemic symptom unawareness (History of impaired autonomic responses (tremulousness, sweating, palpitations, and hunger) during hypoglycaemia). - d) Treated with insulin for more than 5 years. - e) Episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (equal to or below 70 mg/dL [equal to or below 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening). - Subjects diagnosed (clinically) with type 2 diabetes mellitus. - Treated with basal only insulin (once daily or twice-daily insulin (insulin detemir; insulin glargine 100 U/mL, biosimilar of insulin glargine 100 U/mL or insulin Neutral Protamine Hagedorn)) equal to or above 90 days prior to the day of screening with or without any of the following anti-diabetic drugs with stable doses for equal to or above 90 days prior to screening: - a) Metformin - b) Dipeptidyl peptidase -4 inhibitor - c) Sodium-glucose co-transporter 2 inhibitor - d) Alpha-glucosidase-inhibitors (acarbose) - e) Thiazolidinediones - f) Marketed oral combination products only including the products listed in criteria 5a-5e - HbA1c equal to or below 9.5% (80 mmol/mol) at screening by central laboratory analysis. - BMI equal to or below 45 kg/m^2. Exclusion Criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin degludec
For subcutaneous (s.c., under the skin) injection once daily
• Insulin glargine
For subcutaneous (s.c., under the skin) injection once daily

Locations

Country	Name	City	State
Canada	Novo Nordisk Investigational Site	Brampton	Ontario
Canada	Novo Nordisk Investigational Site	Calgary	Alberta
Canada	Novo Nordisk Investigational Site	Etobicoke	Ontario
Canada	Novo Nordisk Investigational Site	Hamilton	Ontario
Canada	Novo Nordisk Investigational Site	Markham	Ontario
Canada	Novo Nordisk Investigational Site	Mirabel	Quebec
Canada	Novo Nordisk Investigational Site	Oakville	Ontario
Canada	Novo Nordisk Investigational Site	Sherbrooke	Quebec
Canada	Novo Nordisk Investigational Site	Toronto	Ontario
Denmark	Novo Nordisk Investigational Site	Aarhus N
Denmark	Novo Nordisk Investigational Site	Esbjerg
Denmark	Novo Nordisk Investigational Site	Hellerup
Denmark	Novo Nordisk Investigational Site	Hillerød
Denmark	Novo Nordisk Investigational Site	Hvidovre
Denmark	Novo Nordisk Investigational Site	Odense
Estonia	Novo Nordisk Investigational Site	Pärnu
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Tallinn
Estonia	Novo Nordisk Investigational Site	Viljandi
Germany	Novo Nordisk Investigational Site	Bad Mergentheim
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Elsterwerda
Germany	Novo Nordisk Investigational Site	Essen
Germany	Novo Nordisk Investigational Site	Essen
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	Lingen
Germany	Novo Nordisk Investigational Site	Rehlingen-Siersburg
Germany	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Athens
Greece	Novo Nordisk Investigational Site	Larissa
Greece	Novo Nordisk Investigational Site	Nikaia
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	Budapest
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Debrecen
Hungary	Novo Nordisk Investigational Site	Kaposvár
Hungary	Novo Nordisk Investigational Site	Szeged
Hungary	Novo Nordisk Investigational Site	Szombathely
Norway	Novo Nordisk Investigational Site	Hamar
Norway	Novo Nordisk Investigational Site	Hoenefoss
Norway	Novo Nordisk Investigational Site	Oslo
Norway	Novo Nordisk Investigational Site	Oslo
Norway	Novo Nordisk Investigational Site	Oslo
Norway	Novo Nordisk Investigational Site	Skedsmokorset
Norway	Novo Nordisk Investigational Site	Trondheim
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Bytom
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Lublin
Poland	Novo Nordisk Investigational Site	Szczecin
Poland	Novo Nordisk Investigational Site	Warsaw
Poland	Novo Nordisk Investigational Site	Zabrze
Puerto Rico	Novo Nordisk Investigational Site	Manati
Puerto Rico	Novo Nordisk Investigational Site	Ponce
Romania	Novo Nordisk Investigational Site	Bucharest
Romania	Novo Nordisk Investigational Site	Bucharest
Romania	Novo Nordisk Investigational Site	Buzau
Romania	Novo Nordisk Investigational Site	Galati
Romania	Novo Nordisk Investigational Site	Oradea	Bihor
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Belgrade
Serbia	Novo Nordisk Investigational Site	Nis
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Albuquerque	New Mexico
United States	Novo Nordisk Investigational Site	Albuquerque	New Mexico
United States	Novo Nordisk Investigational Site	Amarillo	Texas
United States	Novo Nordisk Investigational Site	Anderson	South Carolina
United States	Novo Nordisk Investigational Site	Anniston	Alabama
United States	Novo Nordisk Investigational Site	Arlington	Texas
United States	Novo Nordisk Investigational Site	Austin	Texas
United States	Novo Nordisk Investigational Site	Beaver	Pennsylvania
United States	Novo Nordisk Investigational Site	Bennington	Vermont
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Blackfoot	Idaho
United States	Novo Nordisk Investigational Site	Bloomfield Hills	Michigan
United States	Novo Nordisk Investigational Site	Bountiful	Utah
United States	Novo Nordisk Investigational Site	Bradenton	Florida
United States	Novo Nordisk Investigational Site	Brandon	Florida
United States	Novo Nordisk Investigational Site	Bristol	Tennessee
United States	Novo Nordisk Investigational Site	Buena Park	California
United States	Novo Nordisk Investigational Site	Chandler	Arizona
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	Chattanooga	Tennessee
United States	Novo Nordisk Investigational Site	Chesapeake	Virginia
United States	Novo Nordisk Investigational Site	Chesterfield	Missouri
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	Clearwater	Florida
United States	Novo Nordisk Investigational Site	Colorado Springs	Colorado
United States	Novo Nordisk Investigational Site	Columbus	Ohio
United States	Novo Nordisk Investigational Site	Columbus	Ohio
United States	Novo Nordisk Investigational Site	Concord	California
United States	Novo Nordisk Investigational Site	Cooper City	Florida
United States	Novo Nordisk Investigational Site	Council Bluffs	Iowa
United States	Novo Nordisk Investigational Site	Dakota Dunes	South Dakota
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Downey	California
United States	Novo Nordisk Investigational Site	Duarte	California
United States	Novo Nordisk Investigational Site	East Brunswick	New Jersey
United States	Novo Nordisk Investigational Site	Elkhorn	Nebraska
United States	Novo Nordisk Investigational Site	Englewood	Colorado
United States	Novo Nordisk Investigational Site	Evansville	Indiana
United States	Novo Nordisk Investigational Site	Fort Worth	Texas
United States	Novo Nordisk Investigational Site	Fountain Hills	Arizona
United States	Novo Nordisk Investigational Site	Fremont	Nebraska
United States	Novo Nordisk Investigational Site	Fresno	California
United States	Novo Nordisk Investigational Site	Gaffney	South Carolina
United States	Novo Nordisk Investigational Site	Glendale	Arizona
United States	Novo Nordisk Investigational Site	Glendale	Arizona
United States	Novo Nordisk Investigational Site	Glendale	Arizona
United States	Novo Nordisk Investigational Site	Greensboro	North Carolina
United States	Novo Nordisk Investigational Site	Greenville	North Carolina
United States	Novo Nordisk Investigational Site	Greenville	North Carolina
United States	Novo Nordisk Investigational Site	Greenville	South Carolina
United States	Novo Nordisk Investigational Site	Greer	South Carolina
United States	Novo Nordisk Investigational Site	Gurnee	Illinois
United States	Novo Nordisk Investigational Site	Henderson	Nevada
United States	Novo Nordisk Investigational Site	Honolulu	Hawaii
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Humble	Texas
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Kalispell	Montana
United States	Novo Nordisk Investigational Site	Kenosha	Wisconsin
United States	Novo Nordisk Investigational Site	Kerrville	Texas
United States	Novo Nordisk Investigational Site	Kingsport	Tennessee
United States	Novo Nordisk Investigational Site	Knoxville	Tennessee
United States	Novo Nordisk Investigational Site	La Jolla	California
United States	Novo Nordisk Investigational Site	Lancaster	California
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Lawrenceville	New Jersey
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Lexington	Kentucky
United States	Novo Nordisk Investigational Site	Lomita	California
United States	Novo Nordisk Investigational Site	Los Alamitos	California
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Louisville	Kentucky
United States	Novo Nordisk Investigational Site	Marietta	Georgia
United States	Novo Nordisk Investigational Site	Maumee	Ohio
United States	Novo Nordisk Investigational Site	McMurray	Pennsylvania
United States	Novo Nordisk Investigational Site	Miami	Florida
United States	Novo Nordisk Investigational Site	Miami Springs	Florida
United States	Novo Nordisk Investigational Site	Midlothian	Virginia
United States	Novo Nordisk Investigational Site	Mishawaka	Indiana
United States	Novo Nordisk Investigational Site	Morehead City	North Carolina
United States	Novo Nordisk Investigational Site	Moreno Valley	California
United States	Novo Nordisk Investigational Site	Mount Pleasant	South Carolina
United States	Novo Nordisk Investigational Site	Murray	Utah
United States	Novo Nordisk Investigational Site	Nashua	New Hampshire
United States	Novo Nordisk Investigational Site	Nashville	Tennessee
United States	Novo Nordisk Investigational Site	Nashville	Tennessee
United States	Novo Nordisk Investigational Site	New Braunfels	Texas
United States	Novo Nordisk Investigational Site	New Orleans	Louisiana
United States	Novo Nordisk Investigational Site	New Port Richey	Florida
United States	Novo Nordisk Investigational Site	New Windsor	New York
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	Norfolk	Virginia
United States	Novo Nordisk Investigational Site	Norman	Oklahoma
United States	Novo Nordisk Investigational Site	Northport	New York
United States	Novo Nordisk Investigational Site	Northridge	California
United States	Novo Nordisk Investigational Site	Ogden	Utah
United States	Novo Nordisk Investigational Site	Olympia	Washington
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	Paducah	Kentucky
United States	Novo Nordisk Investigational Site	Palm Harbor	Florida
United States	Novo Nordisk Investigational Site	Palm Springs	California
United States	Novo Nordisk Investigational Site	Pelzer	South Carolina
United States	Novo Nordisk Investigational Site	Pembroke Pines	Florida
United States	Novo Nordisk Investigational Site	Peoria	Illinois
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Phoenix	Arizona
United States	Novo Nordisk Investigational Site	Plano	Texas
United States	Novo Nordisk Investigational Site	Pomona	California
United States	Novo Nordisk Investigational Site	Port Charlotte	Florida
United States	Novo Nordisk Investigational Site	Poway	California
United States	Novo Nordisk Investigational Site	Richfield	Minnesota
United States	Novo Nordisk Investigational Site	Richmond	Virginia
United States	Novo Nordisk Investigational Site	Riverside	California
United States	Novo Nordisk Investigational Site	Rockville	Maryland
United States	Novo Nordisk Investigational Site	Roseville	California
United States	Novo Nordisk Investigational Site	Roswell	Georgia
United States	Novo Nordisk Investigational Site	Sacramento	California
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	San Mateo	California
United States	Novo Nordisk Investigational Site	San Ramon	California
United States	Novo Nordisk Investigational Site	Skokie	Illinois
United States	Novo Nordisk Investigational Site	Spokane	Washington
United States	Novo Nordisk Investigational Site	Springfield	Illinois
United States	Novo Nordisk Investigational Site	Stanford	California
United States	Novo Nordisk Investigational Site	Statesville	North Carolina
United States	Novo Nordisk Investigational Site	Tampa	Florida
United States	Novo Nordisk Investigational Site	Toledo	Ohio
United States	Novo Nordisk Investigational Site	Topeka	Kansas
United States	Novo Nordisk Investigational Site	Tucson	Arizona
United States	Novo Nordisk Investigational Site	Valparaiso	Indiana
United States	Novo Nordisk Investigational Site	Virginia Beach	Virginia
United States	Novo Nordisk Investigational Site	Vista	California
United States	Novo Nordisk Investigational Site	Waco	Texas
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	Wauconda	Illinois
United States	Novo Nordisk Investigational Site	West Allis	Wisconsin
United States	Novo Nordisk Investigational Site	West Columbia	South Carolina
United States	Novo Nordisk Investigational Site	West Des Moines	Iowa
United States	Novo Nordisk Investigational Site	West Hills	California
United States	Novo Nordisk Investigational Site	West Seneca	New York
United States	Novo Nordisk Investigational Site	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Estonia,  Germany,  Greece,  Hungary,  Norway,  Poland,  Puerto Rico,  Romania,  Serbia, 

References & Publications (2)

Philis-Tsimikas A, Klonoff DC, Khunti K, Bajaj HS, Leiter LA, Hansen MV, Troelsen LN, Ladelund S, Heller S, Pieber TR; CONCLUDE Study Group. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 d — View Citation

Philis-Tsimikas A, Stratton I, Nørgård Troelsen L, Anker Bak B, Leiter LA. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 Weeks
Secondary	Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)	The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).	88 weeks
Secondary	Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 weeks
Secondary	Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 weeks (maintenance 2)
Secondary	Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)	Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88).	Week 0, week 88
Secondary	Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)	Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88).	Week 0, week 88
Secondary	Percentage of Participants With FPG = 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)	Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks).	At 88 weeks
Secondary	Percentage of Participants With FPG = 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)	Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks).	At 88 weeks
Secondary	Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)	Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).	End of Treatment (up to 88 Weeks)
Secondary	Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)	Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).	At 88 weeks
Secondary	Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)	Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented.	Week 0, week 88
Secondary	Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Secondary	Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Secondary	Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)	Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	88 weeks
Secondary	Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)	The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100.	88 weeks
Secondary	Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)	Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).	Week 0, week 88