A Research Study to See How a Weekly Insulin, Insulin Ico... | NCT07076199

Studies
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes

NCT07076199

Sponsor

Novo Nordisk A/S

Status

Recruiting

Last Update Posted

Jun 29, 2026Actual

Enrollment

877Estimated

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin icodec
Insulin glargine
Insulin aspart

Countries

United States
Australia
Canada
Germany
Poland
Puerto Rico
Romania
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1310-7017	Other Identifier	World Health Organization (WHO)
2024-519945-31	Other Identifier	European Medical Agency (EMA)

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2025Actual

Primary Completion Date

Jan 25, 2027Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Jul 14, 2025

First Submission Date that Met QC Criteria

Jul 14, 2025

First Posted Date

Jul 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

877Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin icodec + insulin aspart	Experimental	Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .	Drug: Insulin icodec Drug: Insulin aspart
Insulin glargine+ insulin aspart	Active Comparator	Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.	Drug: Insulin glargine Drug: Insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin icodec	Drug	Insulin icodec will be administered as subcutaneous injection	Insulin icodec + insulin aspart

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in glycosylated haemoglobin (HbA1c)	Measured in percentage (%)-points.	From baseline (week 0) to week 26

Secondary Outcomes

Measure	Description	Time Frame
Change in time in range 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))	Measured in %-points.	From baseline (week-2-0) to week 22-26
Time spent less than (<)3.0 mmol/L (54 mg/dL)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

Exclusion Criteria:

Known or suspected hypersensitivity to study intervention(s) or related products.
Previous participation in this study. Participation is defined as signed informed consent.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).
Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cullman Clinical Trials	Completed	Cullman	Alabama	35055	United States
John Muir Health

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune 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
D061266	Insulin, Short-Acting

ID	Term
C000712207	insulin icodec
D000069036	Insulin Glargine
D061267	Insulin Aspart