Study on the Effectiveness and Safety of Gliclazide MR, Dapagliflozin, and Metformin for Patients with Type 2 Diabetes Not Well Controlled with Dapagliflozin

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What is this study about?

This clinical trial is focused on studying the treatment of Type 2 Diabetes, a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will evaluate the effectiveness and safety of a medication called gliclazide MR in patients whose diabetes is not well controlled with another medication, dapagliflozin, with or without the addition of metformin. Gliclazide MR is a modified-release tablet, which means it releases the medication slowly over time. Dapagliflozin and metformin are also used to help control blood sugar levels in people with Type 2 Diabetes.

The purpose of this study is to see if the combination of gliclazide MR and dapagliflozin, with or without metformin, is better at reducing blood sugar levels compared to a placebo and dapagliflozin, with or without metformin. Participants in the study will be randomly assigned to receive either the combination of medications or a placebo. The study will last for 24 weeks, during which participants will take the medications by mouth as tablets. Throughout the study, participants will have regular check-ups to monitor their blood sugar levels and overall health.

By the end of the study, researchers aim to determine if the combination of gliclazide MR and dapagliflozin, with or without metformin, is more effective in lowering blood sugar levels than the current treatment options. This information could help improve treatment strategies for people with Type 2 Diabetes who are not achieving optimal blood sugar control with their current medications.

1 randomization and treatment initiation

Upon joining the study, participants are randomly assigned to receive either the active treatment or a placebo. The active treatment consists of gliclazide MR in combination with dapagliflozin, with or without metformin. The placebo group receives a placebo in combination with dapagliflozin, with or without metformin.

The medications are taken orally. Gliclazide MR is provided as a modified-release tablet, dapagliflozin as a film-coated tablet, and metformin as a film-coated tablet. The placebo is also administered orally.

2 treatment period

The treatment period lasts for 24 weeks. During this time, participants continue their assigned treatment regimen. The goal is to assess the effectiveness of the treatment in reducing HbA1c levels, which is a measure of blood sugar control over time.

Participants are monitored for changes in HbA1c and fasting plasma glucose (FPG) levels. The study also tracks the proportion of participants achieving specific HbA1c targets and any adverse events, such as hypoglycemic episodes or infections.

3 end of treatment assessment

At the end of the 24-week treatment period, participants undergo a final assessment. This includes measuring changes in HbA1c and FPG from the start of the study.

The study evaluates the proportion of participants who reach the target HbA1c levels and those who require additional therapy. Vital signs, body weight, and laboratory measures are also assessed to ensure safety and effectiveness.

Who Can Join the Study?

Participants must have been diagnosed with Type 2 Diabetes for more than 6 months.
Participants must be 18 years or older.
Participants should have a Body Mass Index (BMI) between 25 and 40 kg/m². BMI is a measure of body fat based on height and weight.
Participants must be on a stable diet and exercise routine.
Participants should be currently treated with one of the following:
- Metformin alone at a stable daily dose of at least 1500 mg for at least 12 weeks before the first screening visit, with HbA1c levels between 8.0% and 11.5%. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
- Dapagliflozin or Empagliflozin alone or in combination with metformin, with a stable daily dose for at least 12 weeks before the first screening visit, with HbA1c levels between 7.5% and 10.5%.
For the treatment period, participants must have HbA1c levels between 7.0% and 10.5%.
For the treatment period, participants must have Fasting Plasma Glucose (FPG) levels of 15 mmol/L or less. FPG is a test that measures blood sugar after fasting for at least 8 hours.
Participants previously treated with metformin alone will be withdrawn if their fasting capillary blood glucose is greater than 15 mmol/L, based on an average of 3 fasting tests, within the week before the third screening visit.

Who Cannot Join the Study?

Patients who have a different type of diabetes other than Type 2 Diabetes.
Patients who have their diabetes well-controlled with their current medication.
Patients who are not taking dapagliflozin or are taking it with other medications not specified in the study.
Patients who are not within the age range specified for the study.
Patients who are part of a vulnerable population that the study does not include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
MBAL Med Line Clinic AD	Plovdiv	Bulgaria
Diab Serwis Popenda Sp. j.	Chorzow	Poland
Rutas Eglites Gimenes Arsta Prakse SIA	Kuldiga	Latvia
Multiprofessional Hospital For Active Treatment Iulia Vrevska-Byala EOOD	Byala	Bulgaria

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Pauls Stradins Clinical University Hospital	Riga	Latvia
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
Borbanya Praxis Egeszsegugyi Kft.	Nyiregyhaza	Hungary
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.	Cracow	Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Clinexpert Kft.	Budapest	Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Niepubliczny Zaklad Opieki Zdrowotnej Euromedica Sp. z o.o.	Grudziadz	Poland
Semmelweis University	Budapest	Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
University Of Pecs	Pecs	Hungary
Belinus Bt.	Debrecen	Hungary
Med-Tima Kft.	Budapest	Hungary
PVN Kutato Kft.	Budapest	Hungary
RH Konsultacijas, SIA	Sigulda	Latvia
Sydufdvubkn Pskpzhzql Ztrszv Zyqcdddh Ovrxzb Zlbouooohj W Wxssbehkl	Wyszkow	Poland
Cxoejvl Mmqypcpv Pfaeuusa Sbc z owyc	Piaseczno	Poland
Pvyydsxj Nuoaqzejh Znzr	Polgar	Hungary
Sjxflpz Ewwaqouzcli Ksdm	Kalocsa	Hungary
Dcinz Tajtsphaubh apide pjteca etjzsoppzimwxud Sdn	Ogre	Latvia
Zuxcbdsz dwqilmn crdhxe Syz	Jelgava	Latvia
Kfexpixckw Uqk	Jonava	Lithuania
Mmwzkia Coqdol Buyriypv Lutk	Yambol	Bulgaria
Pobuydyyg Idfzzeab Mminthiq Mhectysptots Swjsc Wyynndualdfq I Alinwyvitfwtv	Warsaw	Poland
Lcxfpvf Kdka	Baja	Hungary
Djevucaqoi Cauzjfsrpqhn Cfgnic Eulmln Oef	Varna	Bulgaria
Mfqlogz Cjnuni Mkmas Mci Eycq	Sofia	Bulgaria
Hzneygiulqx Uac	Kaunas	Lithuania

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.06.2024
Hungary	Not recruiting	30.06.2024
Latvia	Not recruiting	30.06.2024
Lithuania	Not recruiting	30.06.2024
Poland	Not recruiting	30.06.2024

Trial locations

Investigated drugs:

Gliclazide MR is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the amount of insulin released by the pancreas, which helps lower blood sugar levels. In this trial, it is being tested to see if it can improve blood sugar control when added to other diabetes medications.

Dapagliflozin is a medication that helps lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. This trial is examining its effectiveness in combination with other diabetes treatments.

Metformin is a common medication used to treat type 2 diabetes. It helps lower blood sugar levels by decreasing the amount of sugar produced by the liver and improving the body’s response to insulin. In this study, it is used alongside other medications to see if it can help better control blood sugar levels.

Investigated diseases:

Type 2 diabetes mellitus

Type 2 Diabetes – This is a chronic condition that affects the way the body processes blood sugar (glucose). In Type 2 Diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn’t produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications and maintain health.

Trial ID:

2024-511408-18-00

Protocol code:

S005201-175

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Gliclazide MR, Dapagliflozin, and Metformin for Patients with Type 2 Diabetes Not Well Controlled with Dapagliflozin

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?