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
University Of Debrecen Debrecen Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Hospital Clinic De Barcelona Barcelona Spain
Poliklinika Solmed d.o.o. Zagreb Croatia
Hospital General Universitario Gregorio Maranon Madrid Spain
Santa Sp. z o.o. Lodz Poland
Thermi Clinic S.A. Thessaloniki Greece
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Clinical Medical Center Osijek Osijek Croatia
Specderm Poznanska Sp. j. Bialystok Poland
Opca Bolnica Karlovac Karlovac Croatia
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Euromedica General Clinic Of Thessaloniki Thessaloniki Greece
InnoDiab Forschung GmbH Essen Germany
Lukmed 2 Sp. z o.o. Siedlce Poland
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Cabinet Medical Dr Geru S.R.L. Timisoara Romania
Mariodiab Clinic S.R.L. Brasov Romania
Mediab S.R.L. Targu Mures Romania
Grandmed S.R.L. Oradea Romania
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j. Legnica Poland
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o. Cracow Poland
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Krapinske Toplice Croatia
Medivasa s.r.o. Zilina Slovakia
424 Military General Training Hospital Thessaloniki Greece
Opca Bolnica Varazdin Varazdin Croatia
Lzwsl Gndjkuc Hqdyjzjl Ou Atjsmd Athens Greece
Hocvbjhl Uxmxllvxdzdqd dh A Crhnzq A Coruna Galicia Spain
Arpbmn Mffsolk Ctdsxj Sntg Thessaloniki Greece
Hghbemjk Uyuhszxxwiekr Mnbbrkc Dv Veauendkja Santander Spain
Uvjirvbhnw Glmirum Hyznxqnk Aehtvhh Athens Greece
Fpxkrb 2 Sjg z onap Oświęcim Poland
Eqmkii Sra z oumm Lublin Poland
Dkcakdmf spaqfu Presov Slovakia
Nqroi Mvxwlga Cvvxgoj Syertu Ploiesti Romania
Mzylsyk Capbbr Afsfm Igj Psrvibm Elam Sofia Bulgaria
Kbjyifqz bneaeink cwkzrr Rmzyvs (kvvvgisw Hwumtxpo Cxbjuc Rdykdpn Rijeka Croatia
Dbmoebrk sguwyj Poprad Slovakia
Mgedolw Cwnpdw Rpddsy Ltfa Cwosrh Lqbp Sofia Bulgaria
Ifsegzchdt Pgksocyu Frj Shqdezchseh Ogtlvfpvajde Mknqfxr Cxbs Dazldx Mvwutxn Rfgkfz Lcrn Kyustendil Bulgaria
Pwwyh Fcigta Mz scveee Sahy Slovakia
Avbunlevga Foo Iinflzejuu Pqwzekzv Feb Strquhzzved Mrpyzip Cnfq Kayrtr Erhp Varna Bulgaria
Pfgrtzims Iwlhyqsb Mceeywph Msinybmemygy Sbdfi Wshevcwoyuan I Acsvmtcjnmgzf Warsaw Poland
Nbix Ehvkt Sxx z opwh Bialystok Poland

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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