New combo shot aims to simplify type 2 diabetes management
NCT ID NCT06716424
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study tests a fixed-dose combination of insulin glargine and lixisenatide (iGlarLixi) in 105 adults with type 2 diabetes whose blood sugar is not well controlled on oral drugs or other injectables. The main goal is to check safety and side effects, while also measuring changes in blood sugar levels over time. All participants receive the same treatment, so there is no placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- insulin glargine/lixisenatide (iGlarLixi)
- What this could lead to
- If successful, this could offer a convenient single-injection option to help people with type 2 diabetes better control their blood sugar.
- What could go wrong
- This is a single-arm, phase 4 study with no comparison group, so results may be less definitive. Side effects like low blood sugar or gastrointestinal 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
-
105 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
-
Jun 2026
- 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 must be ≥18 years of age, at the time of signing the informed consent * Participants with Type 2 Diabetes diagnosed for at least 1 year at the time of screening on treatment with Metformin +/- OADs or basal insulin/GLP-1RA for a minimum period of 6 months prior to screening * HbA1c between ≥ 7.5% and ≤10.5% inclusive, during screening * Participant with BMI \>= 25 kg/m2 (as per Endocrine Society of India, Ref 12) * Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27) * Signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Type 1 Diabetes mellitus or any diabetes other than T2DM * Prior use of any combination of Basal Insulin + GLP-1 RA Fixed Ratio or Free Combination, Premix Insulin, Basal bolus therapy * Basal insulin dose \>50 U at screening * Any clinically-significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment * Known presence of factors that interfere with the HbA1c measurement (e.g., specific hemoglobin variants, hemolytic anemia) compromising the reliability of HbA1c assessment or medical conditions that affect interpretation of HbA1c results (e.g., blood transfusion or severe blood loss in the last 3 months prior to baseline, any condition that shortens erythrocyte survival) * History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit * Proliferative retinopathy or maculopathy requiring treatment according to the Investigator * Use of weight loss drugs (including over-the-counter and herbal medications) within 12 Weeks prior to the screening visit * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit * Likelihood to require treatment prohibited by the protocol during the study. * Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment * Any specific situation during study implementation/course that may raise ethics considerations * History of hypoglycemia unawareness * Patients with known hypersensitivity to lixisenatide, insulin glargine or to any of the inactive ingredients in the formulation * History of drug or alcohol abuse within 6 months prior to screening visit The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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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.
Contacts and locations
Locations
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Investigational Site Number : 3560001
Kolkata, 700020, India
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Investigational Site Number : 3560003
Kanpur, 208002, India
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Investigational Site Number : 3560005
Hyderabad, 500034, India
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Investigational Site Number : 3560006
Indore, 452010, India
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Investigational Site Number : 3560007
Delhi, 110088, India
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Investigational Site Number : 3560008
Pune, 411004, India
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Investigational Site Number : 3560009
Bengaluru, 560054, India
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Investigational Site Number : 3560011
Jaipur, 302020, India
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Investigational Site Number : 3560014
Visakhapatnam, 530040, India
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Investigational Site Number: 3560013
Pune, 411057, India
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