Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
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Description de l'étude
The aim of this study is to see if the test drug S05762, combined with dapagliflozin, is safe and works well for people with type 2 diabetes.
Type 2 diabetes is a disease where the body can’t use insulin properly, causing high blood sugar. It’s important to control blood sugar to avoid serious problems with blood vessels, nerves, eyes, and kidneys.
Different drugs can be used together to help control blood sugar.
S05762, also called gliclazide modified release, has been used since 2008 to treat high blood sugar in type 2 diabetes. It helps the pancreas make more insulin.
Dapagliflozin has been used since 2012 to treat high blood sugar in type 2 diabetes. It helps remove sugar from the body through urine.
If participants are already taking metformin, S05762 and dapagliflozin will be added to their treatment.
The main goals of this study are:
- To see if S05762 combined with dapagliflozin works well for treating type 2 diabetes.
- To check if S05762 combined with dapagliflozin is safe.
- Ivosidenib
- Recommended Combination Dose (RCD) of ivosidenib
- Nivolumab
- Ipilimumab
- CL1-95031-006
Critères d'éligibilité
Age éligible pour l’étude
Sexes
Homme/FemmeAccepte les volontaires en bonne santé
NonTo take part in the study, participants have to:
- be at least 18 years old.
- have a Body Mass Index (BMI) between 25 and 40.
- have Type 2 diabetes, which was diagnosed more than 6 months ago.
- be following a stable diet and exercise plan.
- be currently taking metformin alone at a daily dose of at least 1500 mg for the past 12 weeks, or dapagliflozin or empagliflozin alone or with metformin at a daily dose of at least 1500 mg for the past 12 weeks.
- use effective birth control methods during the study and for a specified period after the last dose of the study medication to prevent pregnancy.
Participants will not be able to join the study if they:
- cannot swallow pills or are unlikely to cooperate with the study or study procedures.
- are currently participating or have participated in another drug study within the past 3 months.
- have type 1 diabetes or have used certain diabetes medications recently.
- have used certain other medications recently, including weight loss drugs.
- have serious heart problems, high blood pressure, or liver disease.
- have a weakened immune system, diabetic complications, or serious eye problems.
- have had significant gastrointestinal surgery or issues.
- have had cancer within the past 3 years (except treated skin cancer).
- have mental health issues, drug/alcohol abuse, or psychiatric disorders that are not well-controlled.
- have any condition that the study doctor believes makes it unsafe to participate.
- are allergic to gliclazide or dapagliflozin, or their ingredients.
- have donated blood, lost a lot of blood, or had a blood transfusion recently.
Comment l'étude est-elle conçue ?
Glicazide MR
Glicazide MR 60 mg tablets
0.5-1 oral tablet once a day at breakfast meal
Dapagliflozin 10 mg with or without metformin
1 oral tablet once a day at breakfast meal
Matched placebo
Placebo tablets
0.5-1 oral tablet once a day at breakfast meal
Dapagliflozin 10 mg with or without metformin
1 oral tablet once a day at breakfast meal