A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.

Diabetes Mellitus, Type 2 Clinical Trial

— DUAL™ I Japan  

Official title:

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607306
• Other study ID #: NN9068-4183
• Secondary ID: U1111-1170-1332J
• Status: Completed
• Phase: Phase 3
• Start date: November 18, 2015
• Est. completion date: December 22, 2017

Study information

• Verified date: March 2021
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: December 22, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female Japanese subjects, age at least 20 years at the time of signing informed consent

• Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

• HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%

• Body-mass index (BMI) above or equal to 20 kg/m^2

• Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling

Exclusion Criteria:

• Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening

• Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism

• Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal

• Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

• Screening calcitonin equal to or above 50 ng/L

• History of pancreatitis (acute or chronic)

• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin degludec/liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
• insulin degludec
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
• liraglutide
Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Adachi-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Akita-shi, Akita
Japan	Novo Nordisk Investigational Site	Annaka-shi, Gunma
Japan	Novo Nordisk Investigational Site	Asahikawa-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Chiba-shi, Chiba
Japan	Novo Nordisk Investigational Site	Chitose, Hokkaido
Japan	Novo Nordisk Investigational Site	Chuo-ku,
Japan	Novo Nordisk Investigational Site	Chuo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Chuo-ku,Tokyo
Japan	Novo Nordisk Investigational Site	Edogawa-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Fujisawa-shi, Kanagawa
Japan	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Fukushima
Japan	Novo Nordisk Investigational Site	Gunma
Japan	Novo Nordisk Investigational Site	Hachioji-shi, Tokyo
Japan	Novo Nordisk Investigational Site	Hokkaido
Japan	Novo Nordisk Investigational Site	Hokkaido
Japan	Novo Nordisk Investigational Site	Ibaraki
Japan	Novo Nordisk Investigational Site	Ichihara-shi, Chiba
Japan	Novo Nordisk Investigational Site	Iruma-shi, Saitama
Japan	Novo Nordisk Investigational Site	Itabashi-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Itabashi-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Izumisano-shi
Japan	Novo Nordisk Investigational Site	Izumisano-shi,Osaka
Japan	Novo Nordisk Investigational Site	Kagoshima-shi, Kagoshima
Japan	Novo Nordisk Investigational Site	Kamakura-shi
Japan	Novo Nordisk Investigational Site	Kanagawa
Japan	Novo Nordisk Investigational Site	Kanra-gun, Gunma
Japan	Novo Nordisk Investigational Site	Kashiwara-shi, Osaka
Japan	Novo Nordisk Investigational Site	Kawagoe-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kawaguchi-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kawasaki-shi,Kanagawa
Japan	Novo Nordisk Investigational Site	Kisarazu-shi, Chiba
Japan	Novo Nordisk Investigational Site	Kobe-shi, Hyogo
Japan	Novo Nordisk Investigational Site	Kuki-shi, Saitama
Japan	Novo Nordisk Investigational Site	Kumamoto
Japan	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto
Japan	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto
Japan	Novo Nordisk Investigational Site	Kushiro-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Kyoto-shi, Kyoto
Japan	Novo Nordisk Investigational Site	Minato-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Mito-shi, Ibaraki
Japan	Novo Nordisk Investigational Site	Mito-shi, Ibaraki
Japan	Novo Nordisk Investigational Site	Miura-shi, Kanagawa
Japan	Novo Nordisk Investigational Site	Miyazaki
Japan	Novo Nordisk Investigational Site	Nagoya-shi, Aichi
Japan	Novo Nordisk Investigational Site	Nagoya-shi, Aichi
Japan	Novo Nordisk Investigational Site	Nishinomiya-shi, Hygo
Japan	Novo Nordisk Investigational Site	Obihiro-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Obihiro-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Oita-shi
Japan	Novo Nordisk Investigational Site	Okawa-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Onga-gun, Fukuoka
Japan	Novo Nordisk Investigational Site	Osaka
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Osaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Ota-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Saijo-shi, Ehime
Japan	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Sendai-shi, Miyagi
Japan	Novo Nordisk Investigational Site	Sendai-shi, Miyagi
Japan	Novo Nordisk Investigational Site	Shimotsuke-shi, Tochigi
Japan	Novo Nordisk Investigational Site	Shizuoka-shi, Shizuoka
Japan	Novo Nordisk Investigational Site	Tochigi
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Toshima-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Toyonaka-shi, Osaka
Japan	Novo Nordisk Investigational Site	Ube-shi, Yamaguchi
Japan	Novo Nordisk Investigational Site	Urasoe-shi,
Japan	Novo Nordisk Investigational Site	Yamaguchi-shi, Yamaguchi
Japan	Novo Nordisk Investigational Site	Yamato-shi, Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (2)

Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N. Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naïve Japanese patients wi — View Citation

Komatsu M, Watada H, Kaneko S, Ross Agner BF, Nishida T, Kaku K. Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira	Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).	Week 0, Week 52
Secondary	Change From Baseline in Body Weight (kg)	Change from baseline (week 0) in body weight after 52 weeks of treatment.	Week 0, Week 52
Secondary	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes	Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.; Severe hypoglycaemia according to the ADA definition: 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.	Weeks 0-52
Secondary	Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg	Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.	Week 0, Week 52
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline (week 0) in FPG after 52 weeks	Week 0, Week 52
Secondary	Insulin Dose	Actual daily total insulin dose after 52 weeks of treatment.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 7.0%	Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero	Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.	Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.; Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment	Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.; Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 6.5%	Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero	Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.	Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.; Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.	After 52 weeks of treatment
Secondary	Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment	Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.; Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.	After 52 weeks of treatment
Secondary	Change in Waist Circumference	Change from baseline (week 0) in waist circumference after 52 weeks of treatment.	Week 0, Week 52
Secondary	Change in Blood Pressure (Systolic and Diastolic)	Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.	Week 0, Week 52
Secondary	Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)	Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.	After 52 weeks of the treatment
Secondary	Change in SMBG 9-point Profile - Mean of the 9-point Profile	Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.	Week 0, week 52
Secondary	Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)	Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.	Week 0, week 52
Secondary	Total Cholesterol as a Ratio to Baseline at 52 Weeks	Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks	Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks	High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks	Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Triglycerides as a Ratio to Baseline at 52 Weeks	Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Free Fatty Acids as a Ratio to Baseline at 52 Weeks	Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Fasting C-peptide as a Ratio to Baseline at 52 Weeks	Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Fasting Human Insulin as a Ratio to Baseline at 52 Weeks	Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Fasting Glucagon as a Ratio to Baseline at 52 Weeks	Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Proinsulin as a Ratio to Baseline at 52 Weeks	Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.	After 52 weeks of treatment
Secondary	Number of Treatment Emergent Adverse Events (TEAEs)	Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event 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 drug date, then this event was considered as a TEAE.	0-52 weeks
Secondary	Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes	Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.; Severe hypoglycaemia according to the ADA definition: 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.	0-52 weeks
Secondary	Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes	Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).; Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.; Severe hypoglycaemia according to the ADA definition: 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.	0-52 weeks
Secondary	Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition	Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories: Severe hypoglycaemia; Documented symptomatic hypoglycaemia; Asymptomatic hypoglycaemia; Probable symptomatic hypoglycaemia; Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.	0-52 weeks
Secondary	Anti-drug Antibodies: Anti-insulin Degludec Antibodies	Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound & precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.	at week 52
Secondary	Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies	Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.	at week 52
Secondary	Change in Clinical Evaluation: Fundoscopy or Fundus Photography	The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52.	at screening (week -2 to week 0), at week 52
Secondary	Change in Clinical Evaluation: Electrocardiogram (ECG)	The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52.	at screening (week -2 to week 0), at week 52
Secondary	Change in Clinical Evaluation: Pulse	Change in pulse after 52 weeks of treatment.	Week 0, week 52
Secondary	Serum Concentrations of Insulin Degludec	Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.	Weeks 2, 8, 16, 26, 44, 52
Secondary	Plasma Concentrations of Liraglutide	Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.	Weeks 2, 8, 16, 26, 44, 52

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