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

Gå till den engelska sidan

New triple therapy could improve diabetes control

NCT ID NCT03899402

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether adding two extra medications (semaglutide and dapagliflozin) to insulin helps adults with type 1 diabetes control their blood sugar better than insulin alone or with just one extra drug. The 78 participants, aged 18-70 with a BMI of 25 or higher, will be followed for 12 months. The main goal is to see if the triple therapy lowers HbA1c, a key measure of long-term blood sugar control.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

78 people

The number who actually took part.

Started

May 2019

Expected to finish

Jun 2026

An estimate. End dates often move.

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 to 75 years

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: 1. Type 1 Diabetes for at least 1 year on staple use of continuous subcutaneous insulin infusion (CSII) or multiple daily (four or more) injections (MDI) of insulin for last 3 months. 2. C-peptide \<0.23 nM 3. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII 4. Regularly measuring blood sugars four or more times daily. 5. HbA1c of \>7.5%. 6. Well versed in CHO counting\* 7. Age 18-70 years. 8. BMI ≥25 kg/m2. Exclusion Criteria: 1. Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY 2. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months. 3. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit 4. Frequent episodes of severe hypoglycemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), and/or glucagon therapy administered by a third-party individual within 1 month prior to the screening visit 5. Symptoms of poorly controlled diabetes that would preclude participation in this trial 6. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program 7. History of bariatric surgery or lap-band procedure within 12 months prior to screening 8. History of Addison's disease or chronic adrenal insufficiency 9. History of diabetes insipidus 10. Hepatic disease or cirrhosis with Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN 11. Serum Total Bilirubin \> 2X ULN unless exclusively caused by Gilbert's Syndrome 12. Hemoglobin \< 11.0 g/dL (110 g/L) for men; hemoglobin \< 10.0 g/dL (100 g/L) for women. 13. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months or patients with congestive heart failure. 14. ESRD on hemodialysis; and or e-GFR \< 60 ml/min/1.73m2 15. HIV or Hepatitis B/C positive status 16. Any other life-threatening, noncardiac disease 17. History of pancreatitis 18. Women who are pregnant or women of childbearing potential who are not using adequate contraception or who are breast feeding 19. Inability to give informed consent 20. History of gastroparesis 21. History of medullary thyroid carcinoma or MEN 2 syndrome 22. History of serious hypersensitivity reaction to these agents 23. Painful gallstones 24. Alcoholism 25. Hypertriglyceridemia (\>500 mg/dl) 26. Recurrent genital mycotic infection. 27. Hypovolemic patients or with chronic renal insufficiency. 28. Patients with any malignancy except treated in situ malignancy and basal cell carcinoma of the skin 29. Unexplained hematuria 30. Patients with a history of diabetic retinopathy 31. Use of an investigational agent or therapeutic regimen within 30 days of study 32. Participation in any other concurrent interventional clinical trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Type 1 diabetes are added.

Vår säkerhetsrekommendation!

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.

Contacts and locations

Locations

  • Diabetes and Endocrinology Research Center of WNY

    Williamsville, New York, 14221, United States

More trials for these conditions

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