Study of oral and injectable NNC0487-0111 (Amycretin) to find the best dose for blood sugar control in adults with type 2 diabetes taking metformin with or without SGLT2 inhibitor

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What is this study about?

This clinical trial investigates a new medication called NNC0487-0111 for treating people with Type 2 Diabetes. The study aims to determine how different doses of this medication, given either as a weekly injection under the skin or as a daily tablet, affect blood sugar levels in patients whose diabetes is not well controlled with current treatments. The medication being tested is a special type of protein that works by targeting specific receptors in the body that help regulate blood sugar.

During the study, participants will receive either NNC0487-0111, placebo, or standard diabetes medications including metformin and a type of medication called SGLT2 inhibitor (dapagliflozin). The treatment period will last for 36 months, during which participants will need to wear a special device that continuously monitors their blood sugar levels.

The study will measure several health indicators, including changes in blood sugar control (HbA1c), body weight, blood pressure, and various blood tests. Researchers will also monitor kidney function and check for any side effects of the treatment. This research will help determine the most effective and safe dose of the new medication for future use in treating diabetes.

1 Initial phase

You will start taking your current metformin medication, with or without SGLT2 inhibitor.

Your blood sugar levels will be monitored through a special device called continuous glucose monitoring (CGM) that you need to wear throughout the study.

2 Treatment period

You will receive one of the following treatments:

– Weekly injection under the skin of NNC0487-0111 medicine

– Daily oral tablet of NNC0487-0111 medicine

Placebo (a substance that looks like the medicine but contains no active ingredient)

The treatment period will last for 36 weeks.

3 Monitoring period

Throughout the 36-week period, several health measurements will be taken:

Blood sugar levels (HbA1c)

Body measurements (weight, waist size, body mass index)

Blood pressure

Blood tests for cholesterol and other markers

Urine tests to check kidney function

4 Safety monitoring

Any side effects or health changes will be recorded throughout the study period.

Regular check-ups will be conducted to ensure your safety and monitor your response to the treatment.

5 Study completion

The study is expected to end by October 31, 2025.

Final health assessments will be conducted to evaluate the overall effects of the treatment.

Who Can Join the Study?

  • Age between 18 and 75 years old at the time of signing consent to participate in the study
  • Have been diagnosed with type 2 diabetes for at least 180 days (6 months) before screening
  • Taking stable doses of diabetes medications for at least 90 days before screening:
    Metformin (a common diabetes medication)
    – With or without SGLT2 inhibitor (a medication that helps lower blood sugar)
  • Have a HbA1c level (a blood test that measures average blood sugar over the past 3 months) between 7.0% and 10.0%
  • Have a body mass index (BMI) between 23.0 and 50.0 kg/m2 (BMI is a measure of body fat based on height and weight)
  • Be willing and able to:
    – Follow the study protocol
    – Wear a continuous glucose monitoring (CGM) device (a small sensor that continuously measures blood sugar levels)

Who Cannot Join the Study?

  • Age below 18 years or above 75 years
  • Diagnosis other than Type 2 Diabetes
  • Not currently taking metformin (a common diabetes medication)
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials
  • History of severe allergic reactions to medications
  • Serious heart, kidney, or liver problems
  • Uncontrolled high blood pressure
  • History of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids)
  • Use of insulin therapy
  • History of pancreatic disease
  • Severe obesity
  • Active cancer or cancer treatment
  • Substance abuse within the past year
  • Mental health conditions that could interfere with study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Krapinske Toplice Croatia
424 Military General Training Hospital Thessaloniki Greece
Uwcrjpgcdf Ox Dssezspx Debrecen Hungary
Lremq Gldszfa Hnjqgimc Or Afgpvg Athens Greece
Diykacfynzkexwpjpinqnns ckzqkq “cjojozdkkmovnlg Eaiw Sofia Bulgaria
Hlzgpmjg Uqjzopssrblrf dp A Cffxtl A Coruna Galicia Spain
Hlkbgabz Cpsjok Du Bcieifsfw Barcelona Spain
Ahknkg Mycclps Cegytp Sruf Thessaloniki Greece
Pzbyrnrwqgx Sciwaf duuinr Zagreb Croatia
Huywevhe Uirxnjhabtgba Mhexuom Dk Vvsazedixg Santander Spain
Sbfpf Sgh z otha Lodz Poland
Thaudw Cnclni Smot Thessaloniki Greece
Uzupxmzbmt Gzeovnl Hxeukmbb Aapzpso Athens Greece
Uyebuqmlug Mfmntiaamefb Hzixmidk Fgv Aqjglt Tiiyuljcg Svmjv Gzttxc Ecg Plovdiv Bulgaria
Sgnwpv Vvqnvbruh Kweseq Mlf Oiancl Krhcmu Kaposvar Hungary
Sfefaidz Cstnpz Jvqelkbw Dd Ukeddnq Pxng Bnsyhfv Timisoara Romania
Ceckkkdl Mjauxen Cxmfhc Ofaitk Osijek Croatia
Sclbebas Poddjdlrr Scl jx Bialystok Poland
Faiaym 2 Sau z onpf Oświęcim Poland
Emsdcn Sih z ofqp Lublin Poland
Dulnlooq sgawmw Presov Slovakia
Nynyn Mpuqsdp Cioywif Sdfqub Ploiesti Romania
Outv Blzdovv Kplpqafk Karlovac Croatia
Mcycfpq Csdafc Aebmm Ikv Puokszj Ekyy Sofia Bulgaria
Kmbwbihp bwytlqzn cxrues Rfivhm (qykukaly Hhggynlb Cbexry Rptxxcm Rijeka Croatia
Ddnfsjlb ssgpox Poprad Slovakia
Mlinduj Cyeccd Rllfin Lwhx Cvfnnk Lefr Sofia Bulgaria
Iusozngfir Puzucefc Fen Sumqfvbdcxx Ozaxadeftgab Mxdhhjc Cupv Dcteyc Momyyua Rwmwgy Lpkc Kyustendil Bulgaria
Pnags Fyiabk My slroxy Sahy Slovakia
Bvrwmqcexlzhwxxsw Kfkgla Es Rmhuccipjqequl Budapest Hungary
Imxhvvvg fdqb Dzymkxkdzdvuebods Mjbdcvvw Gvxk Munster Germany
Axsefdtffv Fbw Irpvskmbsz Pkvzzqqo Fae Shegfqwhovw Mxtznlr Csah Kvopxy Etkm Varna Bulgaria
Psqkqzdgc Iophrcrf Msqnuqcp Mmsnqctojwpy Ssdug Wywqubbmeuew I Aotsbwafabnuc Warsaw Poland
Ehhazyrpmh Glbiqbl Csfvrm Op Tuyzmkaatyjt Thessaloniki Greece
Impxmzth Fqcrljigm Gumi Essen Germany
Lujnov 2 Slk z oktw Siedlce Poland
Rjqjpg Ixtyefvb fsin mvllqnkgjher Samagoy uep Foiccmueqlu Gydp Oldenburg In Holstein Germany
Cnaaqlu Moutlym Dt Gazz Swdloi Timisoara Romania
Mprcqh Strpla Targu Mures Romania
Gzjectgl Scdodt Oradea Romania
Uyxxfhrbrg Mesqyymrfrmx Hsqjmpfi Fuf Abhflo Tzbxobydn Kksjhpx Ewta Plovdiv Bulgaria
Burdc Mhejwfrcfywh &fbxg Dmugmap Dgoeuvdkm Cgrazxecp Sqj jb Legnica Poland
Mlxtnupd Cuidxls Dywjvfmqdbpdsauzhhmuldoqxyqcpnwotxutarrkukxcdi Dvqllrrqthlyq Spf z ogzv Cracow Poland
Muwlhwqj srdizw Zilina Slovakia
Nxnk Extat Ssk z owau Bialystok Poland
Oonk Bozahxy Vlvsqnfn Varazdin Croatia
Mwbhedmde Ccnsrx Sejezv Brasov Romania

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
23.08.2024
Croatia Croatia
Not recruiting
23.08.2024
Germany Germany
Not recruiting
23.08.2024
Greece Greece
Not recruiting
23.08.2024
Hungary Hungary
Not recruiting
23.08.2024
Poland Poland
Not recruiting
23.08.2024
Romania Romania
Not recruiting
23.08.2024
Slovakia Slovakia
Not recruiting
23.08.2024
Spain Spain
Not recruiting
23.08.2024

Trial locations

NNC0487-0111 is an investigational medication being tested in two forms – as a weekly injection under the skin (subcutaneous) and as a daily oral pill. This medication is being studied for treating type 2 diabetes in patients whose blood sugar is not well controlled with their current treatment.

Metformin is a common oral medication used as a first-line treatment for type 2 diabetes. It helps control blood sugar levels by reducing the amount of glucose produced by the liver and improving how the body responds to insulin.

SGLT2 inhibitors are a class of diabetes medications that work by helping the kidneys remove excess sugar from the blood through urination. These medications can be used alongside metformin to help manage blood sugar levels in people with type 2 diabetes.

Investigated Diseases:

Type 2 Diabetes – A chronic metabolic disorder characterized by high blood sugar levels due to the body’s ineffective use of insulin or reduced insulin production. The condition typically develops gradually, with the pancreas initially producing more insulin to compensate for insulin resistance. Over time, the body becomes less able to process glucose effectively, leading to elevated blood sugar levels. The disease often develops in adults and is frequently associated with excess body weight and physical inactivity. Common symptoms include increased thirst, frequent urination, fatigue, blurred vision, and slow healing of wounds.

Trial ID:
2023-509412-28-00
Protocol code:
NN9490-7678
Trial Phase:
Therapeutic exploratory (Phase II)

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