A Research Study to See How Switching From a Daily Basal... | NCT06340854

ID	Type	Description	Link
U1111-1292-6151	Other Identifier	World Health Organization (WHO)
2023-506084-34	Other Identifier	European Medical Agency (EMA)

Label	Type	Description	Intervention Names
Insulin icodec	Experimental	Participants will receive Insulin icodec subcutaneously once weekly.	Drug: Insulin icodec Drug: Insulin glargine
Insulin glargine U100	Active Comparator	Participants will receive Insulin glargine subcutaneously once daily.	Drug: Insulin icodec Drug: Insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
Insulin icodec	Drug	Insulin Icodec will be administered subcutaneously.	Insulin glargine U100 Insulin icodec

Measure	Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Change in HbA1c from week 0 to week 26 in percentage point is presented.	Week 0, Week 26

Measure	Description	Time Frame
Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))	Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.	week -4-0, week 22-26

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Clinical Transparency (dept. 2834)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Valley Research		Fresno	California	93720	United States
Advanced Investigative Medicine, Inc.

PubMed Identifier	Type	Citation	Retractions
42168822	Derived	Rosenstock J, Mathieu C, Feinberg JB, Rao P, Scavenius C, Cheng AYY. Simplified Switching to Once-Weekly Insulin Icodec Without an Initial One-Time Additional Dose Versus Once-Daily Insulin Glargine U100 in Basal Insulin-Treated Type 2 Diabetes (ONWARDS 10): A Randomised Controlled Trial. Diabetes Obes Metab. 2026 May 21. doi: 10.1111/dom.70813. Online ahead of print.

ID	Title	Description
FG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
FG001	Insulin Glargine

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 2, 2024	May 8, 2026

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Glycated Haemoglobin (HbA1c)

Change in HbA1c from week 0 to week 26 in percentage point is presented.

Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

Percentage (%) point

Week 0, Week 26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants	OG000204 OG001201

Title

Denominators

Categories

Title	Measurements
	OG000-0.84± 0.83 OG001-0.58± 0.89

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change from baseline in response after 26 weeks was analysed using ANCOVA model with randomised treatment and region use as fixed factors, and baseline response as covariate.	ANCOVA		<0.0001		Treatment difference	-0.21			2-Sided	95	-0.36	-0.07					Non-Inferiority	Non-inferiority was confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.3%.

Secondary

Change in Time in Range 3.9-10.0 Millimoles Per Litre (mmol/L) (70-180 Milligrams Per Decilitre (mg/dL))

Change in time in range 3.9-10.0 mmol/L (70-180 mg/dL) from week -4-0 to week 22-26 is presented. Time in range is defined as 100 times the number of recorded measurements in glycaemic range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements.

Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

Percentage (%) of time

week -4-0, week 22-26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants

Secondary

Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire Status Version) Total Treatment Satisfaction

Change in DTSQs total treatment satisfaction from week 0 to week 26 is presented. DTSQs measures the satisfaction with diabetes treatment regimens in people with diabetes. The measure consists of 8 items, of which 6 items contribute to 1 global score. Total Treatment Satisfaction score range is 0-36. 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment.

Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

Score on a scale

week 0 to week 26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts

Secondary

Number of Severe Hypoglycaemic Episodes (Level 3)

Number of severe hypoglycaemic episodes (level 3) from baseline (week 0) to week 31 is presented.

Full analysis set included all randomised participants.

Posted

Number

Episodes

From baseline (week 0) to week 31

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants	OG000

Secondary

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose (BG) Meter)

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 31 is presented.

Full analysis set included all randomised participants.

Posted

Number

Episodes

From baseline (week 0) to week 31

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants	OG000

Secondary

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)

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 is presented.

Full analysis set included all randomised participants.

Posted

Number

Episodes

From baseline (week 0) to week 31

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants

Secondary

Time Spent < 3.0 mmol/L (54 mg/dL)

Time spent < 3.0 mmol/L (54 mg/dL) during week 22 - 26 is presented. Time spent below threshold is defined as 100 times the number of recorded measurements below 3.0 mmol/L (54 mg/dL), divided by the total number of recorded measurements.

Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

% of time

Week 22-26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants

Secondary

Change in Time Spent > 10.0 mmol/L (180 mg/dL)

Change in time spent > 10.0 mmol/L 180 mg/dL from week -4 - 0 to week 22-26 is presented. Time spent above threshold is defined as 100 times the number of recorded measurements above 10.0 mmol/L (180 mg/dL) divided by the total number of recorded measurements.

Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Mean

Standard Deviation

% of time

Week -4-0, Week 22-26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants

Secondary

Mean Weekly Insulin Dose

Mean weekly insulin dose from week 24 to week 26 is presented.

Safety analysis set included all randomised participants who are exposed to investigational intervention. Overall number of participants analyzed = Participants with available data for the outcome measure.

Posted

Geometric Mean

Geometric Coefficient of Variation

Units of insulin/week

From week 24 to week 26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants	OG000

Secondary

Change in Body Weight

Change in body weight from baseline (week 0) to (week 26) is presented.

Posted

Mean

Standard Deviation

Kilogram (kg)

Week 0, Week 26

ID	Title	Description
OG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
OG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acquired oesophageal web	Gastrointestinal disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0012 events2 affected206 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Angina unstable	Cardiac disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Arthritis bacterial	Infections and infestations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Atrial flutter	Cardiac disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Carcinoembryonic antigen increased	Investigations	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Coronary artery disease	Cardiac disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Diabetic gangrene	Infections and infestations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Hypersensitivity	Immune system disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Hypertension	Vascular disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Liver abscess	Infections and infestations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Liver injury	Hepatobiliary disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Lumbosacral plexus injury	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Mixed deafness	Ear and labyrinth disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Non-cardiac chest pain	General disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Oedema peripheral	General disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Optic neuritis	Nervous system disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Otitis media acute	Infections and infestations	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Peripheral swelling	General disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Pneumonia	Infections and infestations	MedDRA 28	Systematic Assessment	EG0002 events2 affected206 at risk EG0012 events2 affected206 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Retinal haemorrhage	Eye disorders	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Subarachnoid haematoma	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Syncope	Nervous system disorders	MedDRA 28	Systematic Assessment	EG0001 events1 affected206 at risk EG0010 events0 affected206 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk
Wound infection	Infections and infestations	MedDRA 28	Systematic Assessment	EG0000 events0 affected206 at risk EG0011 events1 affected206 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
BG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Icodec	Participants received once- weekly (OW) insulin icodec subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.	0	206	16	206	42	206
EG001	Insulin Glargine	Participants received once-daily (OD) insulin glargine subcutaneously (s.c.) into the thigh, upper arm or abdomen for 26 weeks. This was followed by a 5-week safety follow-up period.	0	206	12	206	30	206

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diabetic retinopathy	Eye disorders	MedDRA 28	Systematic Assessment	EG00010 events6 affected206 at risk EG00115 events15 affected206 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28	Systematic Assessment	EG00012 events11 affected206 at risk EG0014 events4 affected206 at risk
Nasopharyngitis	Infections and infestations	MedDRA 28	Systematic Assessment	EG00035 events28 affected206 at risk EG00122 events16 affected206 at risk