Type 2 Diabetes
Conditions
Brief summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).
Interventions
DRUGIcoSema
IcoSema will be administered subcutaneously.
DRUGInsulin glargine
Insulin glargine will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female and age above or equal to 18 years at the time of signing the informed consent. * Diagnosed with T2D greater than or equal to (≥) 180 days before screening. * HbA1c ≥ 8.0% (≥ 64.0 millimoles per mole \[mmol/mol\]) as assessed by central laboratory on the day of screening. * Insulin naïve. Short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes. * Currently treated with 1-3 oral anti diabetic drug (OADs) with stable daily doses ≥ 90 days before screening comprising any of the following anti diabetic drug(s) at effective or maximum tolerated dose. * Metformin * Sulfonylureas * Meglitinides (glinides) * Dipeptidyl peptidase (DPP) 4 inhibitors * Sodium glucose co transporter 2 inhibitors * Alpha glucosidase inhibitors * Thiazolidinediones * Marketed oral combination products only including the products listed above. * Body mass index (BMI) less than or equal to (≤) 40.0 kilogram per square meter (kg/m\^2).
Exclusion criteria
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbaring potential and not using highly effective contraceptive method. * Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). * Any episodes of diabetic ketoacidosis or treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. * Presence or history of pancreatitis (acute or chronic) within 180 days before screening. * Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. * Chronic heart failure classified as being in New York Heart Association Class IV at screening. * Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to week 40 | Measured in percentage (%)-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | From baseline (week 0) to week 40 | Measured in kilogram (kg). |
| Time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligram per deciliter [mg/dL]) | From week 36 to week 40 | Measured in % of readings. |
| Time spent less than (<) 3.0 mmol/L (54 mg/dL) | From week 36 to week 40 | Measured in % of readings. |
| Time spent greater than (>) 10.0 mmol/L (180 mg/dL) | From week 36 to week 40 | Measured in % of readings. |
| Weekly basal insulin dose | From week 38 to week 40 | Measured in units of insulin. |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to week 40 | Measured in mmol/l. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction | From baseline (week 0) to week 40 | The DTSQs items are scored on a 7-point graded response scale ranging from 0 to 6. Score ranges from 0 to 36. Higher scores indicate greater the satisfaction with medication. |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose meter) or severe hypoglycaemic episodes (level 3) | From baseline (week 0) to week 45 | Measured in number of episodes. |
| Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) | From baseline (week 0) to week 45 | Measured in number of episodes. |
| Number of severe hypoglycaemic episodes (level 3) | From baseline (week 0) to week 45 | Measured in number of episodes. |
Countries
China, Greece, India, Italy, Japan, Poland, Puerto Rico, South Africa, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed