A trial to investigate the efficacy and safety of insulin degludec/liraglutide in subjects inadequately controlled with sulphonylurea alone or in combination with metformin.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2012/10/003039
• Date of registration: 04-10-2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk AS
• Public title: A trial to investigate the efficacy and safety of insulin degludec/liraglutide in subjects inadequately controlled with sulphonylurea alone or in combination with metformin.
• Scientific title: The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy - DUAL IV
• Date of first enrolment: 15-10-2012
• Target sample size: 429
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=4837
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Germany, India, Israel, The former Yugoslav Republic of Macedonia, Turkey, United States of America

Contacts

• Name: Dr Raman Shetty
• Affiliation: Novo Nordisk India Private Ltd

• Name: Mr Avik Kumar Gosh
• Affiliation: Novo Nordisk India Private Ltd

Key inclusion & exclusion criteria

Inclusion criteria: Age limit above 18 years



Subjects with type 2 diabetes mellitus



HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)



Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)



Body Mass Index (BMI) below or equal to 40 kg m2


Exclusion criteria: Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)



Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)



Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)



Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)



Screening calcitonin above or equal to 50 ng/l



Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)



Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary,carotid or peripheral artery revascularisation procedures



Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigatorâ??s opinion



Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus),neurological, genitourinary or haematological system that in the opinion of the Investigator,may confound the results of the trial or pose additional risk in administering trial product



History of chronic pancreatitis or idiopathic acute pancreatitis



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: Insulin degludec/liraglutide: Injected subcutaneously (under the skin) once daily for 26 Weeks.
The dosewill be individually adjusted. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
Control Intervention1: Placebo: Injected subcutaneously (under the skin) once daily for 26 Weeks. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Primary Outcome(s)

Change in glycosylated haemoglobin (HbA1c)Timepoint: Week 0, Week 26

Secondary Outcome(s)

Number of adverse events (AEs)Timepoint: After 26 weeks of treatment

Change from baseline in fasting plasma glucoseTimepoint: Week 0,Week 26

Change from baseline in body weightTimepoint: Week 0, week 26

Responders achieving pre-defined target: HbA1c below or equal to 6.5%Timepoint: Week 26

Number of severe or minor hypoglycaemic episodesTimepoint: After 26 weeks of treatment

Responders achieving pre-defined target: HbA1c below 7.0%Timepoint: Week 26

Secondary ID(s)

2012-000140-97

U1111-1126-9776

NN 9068 3951 Ver 2.0 dated 27 March 2012

NCT01618162

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 30/07/2012
Contact:

BANGALORE CLINISEARCH INSTITUTIONAL ETHICAL REVIEW BOARD,

Status: Approved
Approval date: 12/08/2012
Contact:

Institutional Ethics Committee,Care Hospital , Hyderabad - 500034,Dr. Bipin Kumar Sethi

Status: Approved
Approval date: 16/08/2012
Contact:

Ethics Committee, Belgaum Diabetes Centre,Belgaum Diabetes Centre Ground and Second floor, Maruti Galli, Belgaum 590001,Dr. Neeta Deshpande

Status: Approved
Approval date: 10/10/2012
Contact:

Institutional Ethics Committee,2nd Floor Pharmacology Department, TNM College & BYL Nair Ch.Hospital, Dr.A.L.Nair Road Mumbai â?? 400 008,Dr. Nikhil Bhagwat

Status: Approved
Approval date: 24/10/2012
Contact:

Independent Ethics Committee,Dhanshree Hospital,NEW SANGVI, PUNEDr. Vaishali Deshmukh,

Status: Approved
Approval date: 06/01/2013
Contact:

SPRiME-HREC (Society for Promotion of Research in Metabolic & Endocrine Disorder -Human Research & Ethics Committee)

Results

• Date Completed: 16/10/2013