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Insulin Icodec Initiation Strategies and Day-4 Supplemental Dosing in Type 2 Diabetes

NCT07747402 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2026-08-05

No results posted yet for this study

Summary

The goal of this clinical trial is to find the best way to start once-weekly insulin icodec in adults with type 2 diabetes who have not used insulin in the past 3 months, so that their fasting blood glucose reaches the target range within the first week. The main questions it aims to answer are:

* Which of three starting-dose methods brings the most people to their fasting blood glucose target by the end of the first week?
* On day 4 after starting, if fasting blood glucose is still high, does giving one extra half-dose of insulin help more people reach target safely?

Participants will be randomly placed into one of three starting-dose groups: a fixed weekly dose, a dose based on their fasting blood glucose, or a dose based on their body weight. Within each group, participants will also be randomly assigned either to receive an extra insulin dose on day 4 if their fasting blood glucose is at or above a set level, or to receive no extra dose.

Participants will:

* Start once-weekly insulin icodec and continue their current non-insulin diabetes medicines
* Check their fasting blood glucose, including on day 4 after starting
* Wear a blinded continuous glucose monitor during the first 2 weeks and the last 2 weeks
* Attend weekly visits for dose adjustment and safety checks over 12 weeks, followed by a 5-week safety follow-up

Conditions

Interventions

DRUG

Insulin icodec

Once-weekly subcutaneous insulin icodec, injected on a fixed weekday between 6:00 and 9:00 in the morning, added to existing non-insulin glucose-lowering therapy. The starting dose is determined by the assigned initiation strategy: a fixed 70 units per week; fasting blood glucose (mmol/L) multiplied by 7; or body weight (kg) multiplied by 0.15 and then by 7. On day 4, participants in Group A with fasting blood glucose at or above 6.8 mmol/L receive a one-time supplemental dose equal to 50% of the starting dose, while Group B receives no supplemental dose. A standardized weekly titration algorithm is applied through Week 12.

Sponsors & Collaborators

  • Xi'an International Medical Center Hospital

    lead OTHER

Principal Investigators

  • Qiuhe Ji · Xi'an International Medical Center Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2027-10-31
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07747402 on ClinicalTrials.gov