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NCT03078478 Clinical Trial

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
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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