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A study to evaluate the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin

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Servier Protocol Code: S005201-175

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 52 locations

Study description

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.
Official title: A phase 3, randomised, double-blind, placebo-controlled study assessing the efficacy and safety of gliclazide MR in patients with type 2 diabetes inadequately controlled with dapagliflozin with or without metformin.
Conditions
Type 2 diabetes
Interventions / Treatments
  • S05762
  • Dapaglifozin
  • Metformin
Other study id numbers
  • S005201-175

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To 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.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Glicazide MR (S05762)

Glicazide MR

Intervention / Treatment
Drug: Glicazide MR

Glicazide MR 60 mg tablets

0.5-1 oral tablet once a day at breakfast meal

Drug: Dapagliflozin with or without metformin

Dapagliflozin 10 mg with or without metformin

1 oral tablet once a day at breakfast meal

Participant Group / Arm
Placebo Comparator: Placebo

Matched placebo

Intervention / Treatment
Drug: Placebo

Placebo tablets

0.5-1 oral tablet once a day at breakfast meal

Drug: Dapagliflozin with or without metformin

Dapagliflozin 10 mg with or without metformin

1 oral tablet once a day at breakfast meal

Keywords

Provided by Servier
Type 2 Diabetes Mellitus Gliclazide Modified Release Dapagliflozin Blood Glucose Control Antidiabetic Drugs
Additional Relevant MeSH Terms Glioma
Diabetes Mellitus, Type 2 Hypoglycemic Agents Gliclazide Dapagliflozin Blood Glucose