Recruiting PHASE4 Diabetes Mellitus, Type 2

Compares treatment options for Diabetes Mellitus, Type 2

Official title A Research Study to See How Well Weekly Insulin Icodec Maintains Blood Sugar Levels Compared to Daily Basal Insulins in Adults With Type 2 Diabetes

ClinicalTrials.gov ID: NCT07112339

What this study is testing

What is Insulin icodec?

Insulin icodec is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for diabetes mellitus, type 2.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study compares insulin icodec, taken once a week, with other basal insulins, taken once a day, in people with type 2 diabetes.The purpose of this study is to see how well the approved injectable weekly insulin icodec maintains blood sugar levels when compared to approved and available daily injectable basal insulins in people with type 2 diabetes. The participants will either be prescribed weekly insulin icodec or a daily basal insulin (insulin glargine, insulin detemir or insulin degludec) based on current standards for the treatment of type 2 diabetes.
  • Phase 4: studies an already-approved treatment
  • Time commitment: about 13 months

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Diagnosed with T2D greater than or equal to (≥) 180 days prior to the day of screening.
  • Treatment with any of the following non-insulin glucose-lowering medication(s) or combination regimen(s) at the time of screening: Metformin...
  • Need of intensification with basal insulin, as indicated at the discretion of the investigator.
  • Recorded HbA1c value ≥7% within the last 90 days prior to randomization.

You likely can't join if

  • Known or suspected hypersensitivity to study intervention(s) or related products.
  • Previous participation in this study. Participation is defined as signed informed consent.
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method.
  • Participation (i.e., received any study intervention) in any treatment clinical study within 90 days before screening.
  • Any disorder which in the investigator's opinion might jeopardize participant's safety.

The study team makes the final eligibility decision.

Where it's taking place

  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • New Westminster, British Columbia, Canada
  • Winnipeg, Manitoba, Canada
  • Moncton, New Brunswick, Canada
  • Brampton, Ontario, Canada
  • Burlington, Ontario, Canada
  • Concord, Ontario, Canada
  • Courtice, Ontario, Canada
  • Etobicoke, Ontario, Canada
  • Greater Sudbury, Ontario, Canada
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Nepean, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Sarnia, Ontario, Canada
  • Toronto, Ontario, Canada
  • Joliette, Quebec, Canada
  • Lévis, Quebec, Canada

+ 44 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 13 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; New Westminster, British Columbia, Canada; Winnipeg, Manitoba, Canada; Moncton, New Brunswick, Canada; Brampton, Ontario, Canada and 58 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.