Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo shot shows promise for Tough-to-Control diabetes

NCT ID NCT05114590

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed Phase 4 study tested Soliqua 100/33, a once-daily injectable combining insulin and a GLP-1 drug, in 124 adults with very uncontrolled type 2 diabetes (HbA1c ≥9%) who were not yet on insulin. The goal was to see if the drug increased the time their blood sugar stayed in a healthy range, measured by continuous glucose monitors over 16 weeks. Participants continued their usual oral diabetes medications during the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Soliqua 100/33 (insulin glargine and lixisenatide combination)
What this could lead to
If successful, this could offer a new treatment option to help people with very uncontrolled type 2 diabetes achieve better daily blood sugar control without starting insulin.
What could go wrong
This is a small, single-arm Phase 4 study with no comparison group, so results may not be definitive. The drug can cause hypoglycemia and gastrointestinal side effects.

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

124 people

The number who actually took part.

Started

Jan 2022

Finished

Apr 2023

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosed with Type 2 Diabetes mellitus (T2DM) for at least 6 months before the baseline period * HbA1c ≥9-13% during the run-in period * On at least 2 OADs with or without GLP-1 RA with stable doses (for both) for 3 months prior to the screening period * Willing and able to wear the CGM device continuously for 14 days to capture CGM measures at baseline until the next site visit and again towards the end of the treatment period * Willing and able to prick fingers a minimum of 2-4 times per week utilizing sterile lancets provided along with a manual blood glucose meter kit * Willing to discontinue the daily (oral or injectable) or weekly GLP-1 RA or DPP 4i prior to administration of iGlarLixi (Soliqua 100/33) * Willing and able to inject iGlarLixi (Soliqua 100/33) and increase dose as needed to achieve SMPG target * Non-pregnant, non-breastfeeding women utilizing a highly-effective contraceptive method or of non-childbearing potential Exclusion Criteria: * Type1 Diabetes mellitus (T1DM) or any other types of diabetes, except T2DM * On meglitinides (eg, nateglinide, repaglinide) * Body mass index (BMI) \>40 kg/m² during the screening period * Any current or previous skin conditions, including (but not limited to) severe psoriasis, burns, eczema, scarring, excessive tattoos, that would inhibit the proper wearing of the CGM device * History of severe nausea and vomiting leading to subsequent discontinuation of GLP-1 RA * Known history or presence of clinically significant pancreatitis or gastroparesis * Participants with an episode of severe hypoglycemia or with hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[for example, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels) diagnosed within the 6 months prior to the screening period * Participants with personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposed to MTC (eg, multiple endocrine neoplasia syndromes) * Significant current (within past 2 months) and/or expected use of medications known to affect glycemia (eg, ≥5 mg/day prednisone) * Use of substances known to interfere with CGM readings, such as aspirin-containing products (\>650 mg/day of salicylic acid) or supplements containing vitamin C (\>1000 mg/day of ascorbic acid) during the 14 days of CGM at either baseline or end of treatment period * Previous treatment with any insulin (except for short term treatment due to intercurrent illness, including gestational diabetes, at the discretion of the investigator) * Had used weight loss drugs (including over the counter and herbal medications) within 12 weeks before the screening visit The above information was not intended to contain all considerations relevant to a 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 mellitus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Clearview Medical Research LLC-Site Number:8400003

    Canyon Country, California, 91351-4138, United States

  • Consano Clinical Research LLC-Site Number:8400010

    Shavano Park, Texas, 78231-1281, United States

  • Downtown LA Research Center Inc - ClinEdge - PPDS-Site Number:8400001

    Los Angeles, California, 90017-5649, United States

  • Endocrinology Associates Inc-Site Number:8400011

    Columbus, Ohio, 43201-3209, United States

  • Floridian Research Institute-Site Number:8400013

    Miami, Florida, 33179-2537, United States

  • Flourish Research - San Antonio - PPDS-Site Number:8400006

    San Antonio, Texas, 78229-3539, United States

  • Hassman Research Institute - HRI - Berlin - CenExel - PPDS-Site Number:8400007

    Berlin, New Jersey, 08009, United States

  • Mid Hudson Medical Research PLLC-Site Number:8400014

    New Windsor, New York, 12553-7754, United States

  • National Research Institute - ClinEdge - PPDS-Site Number:8400004

    Huntington Park, California, 90255-2959, United States

  • National Research Institute - ClinEdge - PPDS-Site Number:8400009

    Huntington Park, California, 90255-2959, United States

  • Northeast Clinical Research of San Antonio LLC-Site Number:8400019

    Schertz, Texas, 78154, United States

  • Palm Research Center, Inc.-Site Number:8400005

    Las Vegas, Nevada, 89128-0463, United States

  • Premier Research Associate-Miami-Site Number:8400002

    Miami, Florida, 33165-7043, United States

  • San Fernando Valley Health Institute - ClinEdge - PPDS-Site Number:8400012

    West Hills, California, 91304-3837, United States

  • Torrance Clinical Research Institute-Site Number:8400008

    Lomita, California, 90717-2101, United States

  • University Clinical Investigators Inc-Site Number:8400020

    Tustin, California, 92780, United States

  • University of Tennessee Health Science Center-Site Number:8400017

    Memphis, Tennessee, 38163, United States

  • University of Texas Southwestern Medical Center-Site Number:8400018

    Dallas, Texas, 75390, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.