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

NCT ID NCT05114590

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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