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New combo therapy for diabetic dialysis patients shows promise

NCT ID NCT02176681

Disease control Sponsor: University Hospital, Strasbourg, France 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding vildagliptin (a diabetes pill) to insulin helps control blood sugar in people with type 2 diabetes who are on hemodialysis. 70 patients were randomly assigned to receive either insulin alone or insulin plus vildagliptin for 12 weeks. The goal was to see if the combination improved blood sugar levels and reduced dangerous lows (hypoglycemia).

What this could mean

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

Active substance
Vildagliptin (Galvus) added to insulin
What this could lead to
If successful, this could provide a safe and effective way to improve blood sugar control in diabetic patients on dialysis, potentially reducing complications.
What could go wrong
This is a small, early-phase study (70 participants) that only lasted 12 weeks, so results may not apply to all patients. Adding a new drug also carries risks of side effects or interactions.

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

70 people

The number who actually took part.

Started

Jun 2014

Finished

Oct 2017

Lead sponsor

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

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: * Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid * Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent * Age \> 18 years * TGO, TPO and lipase \< 3x ULN * effective means of contraception Non-inclusion Criteria: * Blood transfusion in the 2 previous months * Life expectancy less than 1 year * Chronic inflammatory disease * Steroid treatment \> 5mg/day * Cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated * Patient waiting for programmed surgery * History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months * Patients suffering from stage 3 and 4 cardiac insufficiency * Non-compliant patients * History of pancreatitis * History of angioedema * Hypersensitivity to the active substance or to any of the excipients of Galvus® * Pregnancy or breastfeeding

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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.

Haemodialyzed, type 2 diabetes

Contacts and locations

Locations

  • AURAL Clinique Sainte Anne

    Strasbourg, 67000, France

  • AURAL Colmar

    Colmar, 68000, France

  • AURAL Mulhouse

    Mulhouse, 68070, France

  • AURAL Strasbourg

    Strasbourg, 67200, France

  • CH d'Amiens

    Amiens, 80054, France

  • CH de Besançon

    Besançon, 25030, France

  • CH de Dijon

    Dijon, 21079, France

  • CH de Mulhouse

    Mulhouse, 68070, France

  • CH de Nancy

    Nancy, 54000, France

  • CH de Valenciennes

    Valenciennes, 59300, France

  • Clinique Sainte Anne

    Strasbourg, 67000, France

  • Hospices civils de Colmar

    Colmar, 68024, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France