Recruitment

Recruitment Status
Completed
Estimated Enrollment
1047

Inclusion Criteria

HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
Male or female, 18 years or older at the time of signing informed consent

Exclusion Criteria

Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
...
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
History of chronic or idiopathic acute pancreatitis
Acute coronary or cerebrovascular event within 90 days before randomisation
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Screening calcitonin value greater than or equal to 50 ng/L
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Heart failure, New York Heart Association Class IV
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Summary

Conditions
  • Diabetes
  • Diabetes Mellitus - Type 2
  • Diabetes Mellitus, Type 2
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
Male or female, 18 years or older at the time of signing informed consent
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
Male or female, 18 years or older at the time of signing informed consent

Exclusion Criteria

Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
...
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
History of chronic or idiopathic acute pancreatitis
Acute coronary or cerebrovascular event within 90 days before randomisation
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Screening calcitonin value greater than or equal to 50 ng/L
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Heart failure, New York Heart Association Class IV
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)

Tracking Information

NCT #
NCT02128932
Collaborators
Not Provided
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S