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Study Comparing Orforglipron and Dapagliflozin for Adults with Type 2 Diabetes and Poor Blood Sugar Control on Metformin

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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 compare two treatments: Orforglipron (also known by its code name LY3502970) and Dapagliflozin. Participants in the study will continue their current treatment with Metformin, a common medication used to help control blood sugar levels in people with Type 2 Diabetes.

The purpose of the study is to see if Orforglipron is as effective as Dapagliflozin in managing blood sugar levels. Participants will be randomly assigned to receive either Orforglipron or Dapagliflozin, both taken as capsules by mouth once a day. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient. The study will monitor changes in blood sugar levels over time to assess the effectiveness of the treatments.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study aims to provide valuable information on how well Orforglipron works compared to Dapagliflozin in people with Type 2 Diabetes who are already taking Metformin. This research could help improve treatment options for managing blood sugar levels in individuals with this condition.

1 joining the study

Upon joining the study, ensure that you have Type 2 diabetes and have been on a stable treatment with metformin for at least 90 days before the study begins.

Confirm that there has been no significant change in body weight for at least 90 days prior to the start of the study and agree not to start an intensive diet or exercise program aimed at weight loss during the study.

2 randomization

Participants will be randomly assigned to receive either orforglipron or dapagliflozin to compare their effects on blood sugar control.

3 medication administration

If assigned to the orforglipron group, take the medication orally once daily.

If assigned to the dapagliflozin group, take the medication orally once daily.

Both medications are administered in capsule form.

4 monitoring and assessments

Regular monitoring of blood sugar levels will be conducted to assess the change from baseline in Hemoglobin A1c (HbA1c), which is a measure of blood sugar control over time.

Additional health assessments may be conducted to ensure safety and efficacy of the treatment.

5 study duration

The study is expected to continue until July 28, 2025.

Participants are expected to adhere to the study protocol for the entire duration to ensure accurate results.

Who Can Join the Study?

  • Have Type 2 Diabetes, which is a condition where the body doesn’t use insulin properly, leading to high blood sugar levels.
  • Have been on a stable diabetes treatment with metformin for at least 90 days before the study starts. Metformin is a common medication used to help control blood sugar levels.
  • Have not lost or gained body weight for at least 90 days before the study begins and agree not to start an intensive diet or exercise program during the study with the goal of losing weight, except for regular lifestyle or dietary measures for diabetes treatment.
  • Be within the age range of adults, which typically means 18 years and older.
  • Both males and females can participate in the study.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. Lodz Poland
Diabetes-Zentrum-Wilhelmsburg GbR Hamburg Germany

Other Sites

Site Name City Country Status
Diabetes- und Stoffwechselpraxis Bochum Bochum Germany
Sydthfgb Pzsnugfbu Svb jd Bialystok Poland
Cpy Cgizfezy Rjvhwmts Sltckxwj Mibzctgmom Gkqt Berlin Germany
Riw Orlcmbok Gusi Oldenburg In Holstein Germany
Dbikkdvzgljdhwb Sdcvcfnhavlpesnab upo Priuwm fdo Awfmqrklichsxbeh Dsa Vvknddet Wwbleapveuw Rehlingen Germany
Ckvautn Myvwdikb Dyxltogql Radom Poland
Ndtffgnvnqsy Zqtdkn Opdvdb Zbxyaprmnp „nfpeywqxawb z Sgkdgv Grójec Poland
Ejmztp Sla z oduc Lublin Poland
Igplweqy fjml Dfqttntsbmbayvqrd Mgvzykzf Gntd Munster Germany
Innvnxwq Fcpzrtnut Gkdv Essen Germany
Cictsedo Bdzz Sjbcdmxuo Spi z oacv Sgfo Lublin Poland
Mmakseoovfk Erbyd Byquvev Essen Germany
Cqffuwz Mebcmjco Khkgyz Rlhktz Bsbtegaqoqqups I Epz Ktrdulfmbx Sgm ja Bydgoszcz Poland
Moumaolp Cajsblu Dclebgvwfiuzvwugawhofjgibmxdriktyfzayocyklytdl Dyoszmlwkxpye Sep z orxe Cracow Poland
Zloyacb fmh krurahhir Fjpomwaqo Cologne Germany
Czhmtnloq Scz z oggw Lublin Poland
Sfdyydfbbqe Pecdipfix Srtzcgo Kkgtykeyn nw 1 Sfp Zabrze Poland
Dapqqycyccmxfp Dev Laxonjluast Ludwigshafen Am Rhein Germany
Zweiscc Oirsexgrljw Bialystok Poland
Pdjjvs Ddj mtlv Samqnwwzzmzd Lingen (Ems) Germany
Zeoepmn fxx kyrszwjdt Smrfmgy St. Ingbert Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
05.02.2024
Poland Poland
Not recruiting
05.02.2024

Trial locations

Investigated Drugs:

Orforglipron is an oral medication being studied for its ability to help control blood sugar levels in adults with type 2 diabetes. It is taken once daily and is being compared to another diabetes medication to see if it is as effective in managing blood sugar.

Dapagliflozin is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. In this study, it is being used as a comparison to evaluate the effectiveness of orforglipron.

Investigated Diseases:

Type 2 Diabetes – Type 2 Diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, kidneys, eyes, and nerves. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As it progresses, individuals may experience more severe symptoms and complications if blood sugar levels are not managed effectively. Lifestyle factors, such as diet and physical activity, play a significant role in the development and progression of Type 2 Diabetes.

Trial ID:
2023-507206-13-00
Protocol code:
J2A-MC-GZGV
Trial Phase:
Therapeutic confirmatory (Phase III)

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