A clinical trial to compare the glycaemic control and safety of insulin degludec/liraglutide (IDegLira) with insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/08/007216
• Date of registration: 23-08-2016
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk India Private Ltd
• Public title: A clinical trial to compare the glycaemic control and safety of insulin degludec/liraglutide (IDegLira) with insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus
• Scientific title: A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus - DUAL IX
• Date of first enrolment: 26-08-2016
• Target sample size: 416
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15937
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Finland, Hungary, India, Russian Federation, Slovakia, Slovenia, Spain, Switzerland, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

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

3. Subjects diagnosed (clinically) with type 2 diabetes mellitus.

4. HbA1c 7.0-11.0% (53-97 mmol/mol) (both inclusive) by central laboratory analysis.

5. BMI greater than or equal to 20 kg/m2 and lesser than 40 kg/m2.

6. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes.

7. Oral antidiabetic treatment:

a. SGLT2i: Subjects must have been on a stable daily dose of any SGLT2i (greater than or equal to half of the maximum approved dose according to current local label or maximum tolerated dose as documented in subject medical record, or minimum recommended maintenance dose according to current local label) for at least 90 days prior to the day of screening.

b. Combination therapy: Stable daily dose of SGLT2i as outlined above in combination with stable daily dose(s) of metformin with/without DPP4i is allowed:

i. Metformin (greater than or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) for at least 90 days prior to the day of screening.

ii. DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) for at least 90 days prior to the day of screening.

iii. Stable daily doses, as outlined above, of fixed dose combination products combining either SGLT2i and metformin or SGLT2i and DPP4i, according to locally approved label for at least 90 days prior to the day of screening are also allowed
Exclusion criteria: " 1. Known or suspected hypersensitivity to trial product(s) or related products.

2. Previous participation in this trial. Participation is defined as signed informed consent.

3. Receipt of any investigational medicinal product within 90 days prior to screening.

4. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).

5. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening.

6. Use of GLP-1 receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening.

7. Acute decompensation of glycaemic control requiring immediate intensification of treatment to

prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening.

8. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroids carcinoma.

9. Screening calcitonin >= 50 ng/L.

10. History of pancreatitis (acute or chronic).

11. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or

transient ischaemic attack within the past 180 days prior to the day of screening.

12. Subjects presently classified as being in NYHA Class III or IV.

13. Planned coronary, carotid or peripheral artery revascularisation at the day of screening.

14. Renal impairment eGFR 60 mL/min/1.73 m2 as per CKD-EPI.

15. Impaired liver function, defined as ALT >= 2.5 times upper normal limit at screening.

16. Inadequately treated blood pressure as defined as Class 2 hypertension or higher (systolic >= 160

mmHg or diastolic >= 100 mmHg) at screening.

17. Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g., orlistat, thyroid hormones, corticosteroids).

18. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.

19. History or presence of malignant neoplasms within the last 5 years (except basal and squamous

cell skin cancer and in-situ carcinomas).

20. History of diabetic ketoacidosis.

21. Any disorder, except for conditions associated with diabetes, which in the investigatorâ??s opinion

might jeopardise subjectâ??s safety or compliance with the protocol.

"



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 Diabetes Health Condition 2: E11- Type 2 diabetes mellitus

Intervention(s)

Intervention1: Insulin Degludec/Liraglutide
: Starting dose of 10 dose steps (10 Units Insulindegludec+ 0.36 mg Liraglutide) / 26 weeks/ Once daily Injection / Subcutaneous

Control Intervention1: Insulin glargine
: Starting dose of 10 Units (10 Units Insulin Glargine) / 26 weeks/ Once daily Injection / Subcutaneous

Primary Outcome(s)

Change from baseline in HbA1c

Timepoint: Week 0 to week 26

Secondary Outcome(s)

1. Change from baseline in body weight after 26 weeks

2. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks

3. Insulin dose, total daily dose (U)

Timepoint: Week 0 to week 26

Secondary ID(s)

NN9068-4229 ver 2.0 dated 20 NOV 15

U1111-1168-9343

Source(s) of Monetary Support

Novo Nordisk India Private Ltd.

Ethics review

Status: Approved
Approval date: 23/06/2016
Contact:

Ethics Committee of Apollo Gleneagles Hospitals

Status: Approved
Approval date: 18/07/2016
Contact:

The Ethics Committee of Dr V. Seshiah Diabetes Research Institute

Status: Approved
Approval date: 16/09/2016
Contact:

Drug Trial Ethics committee

Status: Approved
Approval date: 16/09/2016
Contact:

Ethics Committee of Peopleâ??s College of Medical Sciences & Research Centre

Status: Approved
Approval date: 17/09/2016
Contact:

Ethics Committee of Osmania Medical College& Osmania General Hospital

Status: Approved
Approval date: 03/10/2016
Contact:

The Ethics Committee of SMS Medical college & Attached Hospitals

Status: Not Applicable
Approval date:
Contact:

Ethics Committee Institute of Medical Sciences situated at Faculty of Medicine Banaras Hindu University

Status: Not Applicable
Approval date:
Contact:

Institutional Ethics committee of PGIMER & Dr RML Hospital

Results

• Date Completed: 18/10/2017