Can a single extra insulin dose speed up blood sugar control?
NCT ID NCT07747402
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial tests different ways to start once-weekly insulin icodec in adults with type 2 diabetes who haven't used insulin recently. Participants are randomly assigned to one of three starting-dose methods: a fixed dose, a dose based on their fasting blood sugar, or a dose based on body weight. Half also receive an extra half-dose on day 4 if their blood sugar is still high. The goal is to see which approach helps more people reach their fasting blood sugar target within the first week, while keeping safety in mind.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Insulin icodec, a once-weekly injectable insulin
- What this could lead to
- If successful, this could identify the safest and most effective way to start once-weekly insulin, helping more people with type 2 diabetes reach their blood sugar goals within the first week of treatment.
- What could go wrong
- This is a phase 4 trial, so the drug is already approved, but the best starting dose strategy is still unclear. The extra day-4 dose might increase the risk of low blood sugar, and results may not apply to everyone with type 2 diabetes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 462 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older * Diagnosis of type 2 diabetes mellitus for at least 180 days * No insulin treatment of any kind within the past 3 months * Currently treated with at least one non-insulin glucose-lowering agent (oral agent or GLP-1 receptor agonist) with inadequate glycemic control, and a clinical indication to start basal insulin * HbA1c of 7.0% to 11.0% at screening * Body mass index of 35.0 kg/m2 or lower * Able and willing to wear a continuous glucose monitor per protocol, to undergo day-4 fasting blood glucose assessment, and to attend all scheduled visits * Provides written informed consent Exclusion Criteria: * Type 1 diabetes, specific types of diabetes, or recent acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state * Level 2 or level 3 hypoglycemia within the past 3 months, or hypoglycemia unawareness * Current use, or use within the past 3 months, of systemic glucocorticoids (excluding inhaled or topical preparations) or other agents that markedly affect blood glucose * Moderate to severe renal impairment (eGFR below 45 mL/min/1.73 m2 by the CKD-EPI 2021 creatinine equation) or need for dialysis * Active liver disease, abnormal liver function (ALT or AST above 3 times the upper limit of normal), or decompensated cirrhosis * Marked edema, large-volume ascites, amputation, or other conditions that may impair accurate body weight measurement or distort weight-based dosing * Known allergy to insulin icodec or its excipients * Extensive skin lesions, allergy to continuous glucose monitor adhesive, or anticipated frequent magnetic resonance imaging that may interfere with monitor wear or interpretation * Active malignancy * Acute cardiovascular or cerebrovascular event (such as myocardial infarction, stroke, or unstable angina) within the past 6 months, or other major illness with short expected survival or poor compliance * Pregnancy or lactation, or women of childbearing potential with pregnancy plans * Participation in another drug or device clinical trial within the past 3 months * Other conditions judged by the investigator to be unsuitable for enrollment or likely to affect participant safety or data reliability
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100, China
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