IcoSema
DrugIcoSema will be administered subcutaneously.
NCT Number: NCT06269107
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Beijing Friendship Hospital, Capital Medical University-Endocrinology, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IcoSema will be administered subcutaneously.
Insulin glargine will be administered subcutaneously.
Time frame: From baseline (week 0) to week 40
Measured in percentage (%)-point.
Time frame: From baseline (week 0) to week 40
Measured in kilogram (kg).
Time frame: From week 36 to week 40
Measured in % of readings.
Time frame: From week 36 to week 40
Measured in % of readings.
Time frame: From week 36 to week 40
Measured in % of readings.
Time frame: From week 38 to week 40
Measured in units of insulin.
Time frame: From baseline (week 0) to week 40
Measured in mmol/l.
Time frame: 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.
Time frame: From baseline (week 0) to week 45
Measured in number of episodes.
Time frame: From baseline (week 0) to week 45
Measured in number of episodes.
Time frame: From baseline (week 0) to week 45
Measured in number of episodes.
Novo Nordisk A/S
Industry
A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4
Acronym: COMBINE 4
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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