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NCT Number: NCT05486065

A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide [2 milligrams (mg), 8 mg, or 16 mg] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Athens ATTIKON, Athens, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female.
  • Aged 18-64 years (both inclusive) at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
  • Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).
  • Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2).
  • Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

Exclusion criteria

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.

Treatment and study plan

semaglutide

Drug

Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Placebo

Drug

Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Primary outcomes

  1. Change in Glycated Haemoglobin (HbA1c)

    Time frame: Baseline (week 0) and End of treatment (week 40)

    Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.

Secondary outcomes

  1. Change in Body Weight

    Time frame: Baseline (week 0) and End of treatment (week 40)

    Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.

  2. Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) up to end of study (week 49)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable & unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up.

  3. Number of Treatment-emergent Severe Hypoglycaemic Episodes

    Time frame: From baseline (week 0) up to end of study (week 49)

    Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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