A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes, Type 2
• Interventions: Drug: Insulin icodec; Drug: Insulin glargine

• Registration Number: NCT06340854
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Study Start: 2024-04-19
• Primary Completion: 2025-05-08
• Study Completion: 2025-06-13
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

• Diagnosed with T2D greater than equal to (≥) 180 days prior to the day of screening.
• HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol), both inclusive, at screening confirmed by central laboratory analysis.
• Treated with once-daily or twice-daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 U/mL, or insulin glargine 300 U/mL) ≥ 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than equal to (≥) 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), Dipeptidyl peptidase 4 (DPP-4) inhibitors, Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors, thiazolidinediones, alphaglucosidase inhibitors, oral combination products (for the allowed individual oral anti- diabetic drugs), oral or injectable glucagon-like peptide 1 receptor agonists (GLP-1 RAs), injectable glucagon-like peptide 1(GLP-1)/ glucose-dependent insulinotropic polypeptide receptor agonist (GIP RA) combination products.
• Body mass index (BMI) ≤ 40.0 kilogram per square meter (kg/m^2).

Exclusion Criteria

• Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening.
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
• Chronic heart failure classified as being in New York Heart Association Class IV at screening.
• Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin glargine U100	Insulin icodec	Participants will receive Insulin glargine subcutaneously once daily.
Insulin icodec	Insulin icodec	Participants will receive Insulin icodec subcutaneously once weekly.
Insulin icodec	Insulin glargine	Participants will receive Insulin icodec subcutaneously once weekly.
Insulin glargine U100	Insulin glargine	Participants will receive Insulin glargine subcutaneously once daily.

Primary Outcome Measures

Name	Time	Method
Change in glycated hemoglobin (HbA1c)	From baseline (week 0) to week 26	Percentage point (%-point).

Secondary Outcome Measures

Name	Time	Method
Number of severe hypoglycaemic episodes (level 3)	From baseline (week 0) to week 31	Number of episodes.
Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter)	From baseline (week 0) to week 31	Number of episodes.
Time spent < 3.0 mmol/L (54 mg/dL)	From week 22 to 26	% of time.
Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL))	From baseline (week -4 to 0) to week 22-26	Percentage (%) of time.
Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction	From baseline (week 0) to week 26	DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contributes to 1 global score. Higher scores on the global score indicate greater satisfaction with treatment. Global score ranges 0- 36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.
Change in time spent > 10.0 mmol/L (180 mg/dL)	From baseline (week-4 to 0) to week 22-26	% of time.
Mean weekly insulin dose	From week 24 to week 26	Units (U).
Change in body weight	From baseline (week 0) to week 26	Kilogram (kg).
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL),confirmed by BG meter) or severe hypoglycaemic episodes (level 3)	From baseline (week 0) to week 31	Number of episodes.

Trial Locations

Locations (70)

Heiwadai Hospital_Internal Medicine; 🇯🇵 Miyazaki, Miyazaki, Japan

Futata Tetsuhiro Clinic Meinohama_Internal medicine; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Oyama East Clinic_Internal Medicine; 🇯🇵 Tochigi, Japan

Hospital Clinico Virgen de la Victoria; 🇪🇸 Málaga, Spain

Advanced Investigative Medicine, Inc.; 🇺🇸 Hawthorne, California, United States

Scripps Whittier Diabetes Inst; 🇺🇸 La Jolla, California, United States

Clinical Trials Research; 🇺🇸 Lincoln, California, United States

Northeast Research Institute of Florida; 🇺🇸 Fleming Island, Florida, United States

South Broward Research LLC; 🇺🇸 Miramar, Florida, United States

Endo Res Solutions Inc; 🇺🇸 Roswell, Georgia, United States

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