New insulin combo aims to improve daily blood sugar control in type 2 diabetes
NCT ID NCT06671587
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a combination insulin drug (iGlarLixi) works better than standard insulin (Gla-100) at keeping blood sugar within a healthy range throughout the day. About 678 Chinese adults with type 2 diabetes who are not well controlled on oral medications will use a continuous glucose monitor for 20 weeks. The goal is to see if iGlarLixi helps them spend more time in the target blood sugar zone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iGlarLixi (a combination of insulin glargine and lixisenatide)
- What this could lead to
- If successful, this could offer a more effective way to manage blood sugar levels in people with type 2 diabetes, potentially reducing complications.
- What could go wrong
- This is a Phase 4 trial, so the drugs are already approved. However, results may not apply to all populations, and side effects like low blood sugar or digestive issues are possible.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 678 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2024
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Participants who are diagnosed as T2D of at least 1 year before screening visit * Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD * Inadequate control * Body mass index (BMI) within the range 20-40 kg/m2 (inclusive) * Is willing and able to wear the CGM device continuously * Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i * Not using another CGM device during the study Exclusion Criteria: * Participants with severe renal dysfunction * Participants with short life expectancy * Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints * Participants with conditions/concomitant diseases precluding their safe participation in this study * An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit * History of clinically significant pancreatitis or severe gastrointestinal disorders * Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication/hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Previous treatment with insulin * Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i) * Use of systemic glucocorticoids * Use of weight loss drugs * History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy * Laboratory findings at the screening visit * Participants have any current or previous skin conditions * Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 2 diabetes (T2D) are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Investigational Site Number: 1560001
RECRUITINGBeijing, 100730, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.