Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT05486065Other idNN9535-4984Other idU1111-1271-9209Other id2022-000882-41

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 245 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 5 countries
United States, Greece, Hungary, Poland, Puerto Rico
Start: 8 Aug 2022
Primary completion: 12 Oct 2023
Completion: 13 Dec 2023
First posted: 3 Aug 2022
Last update posted: 12 Dec 2025
Conditions: Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024

Ph 2
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
NCT05486065
8 Aug 2022 to 13 Dec 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SemaglutideDrug
PlaceboDrug

Arms6

Experimental
Semaglutide 2 mg
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
Placebo comparator
Semaglutide placebo 2 mg
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
Experimental
Semaglutide 8 mg
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
Placebo comparator
Semaglutide placebo 8 mg
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
Experimental
Semaglutide 16 mg
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
Placebo comparator
Semaglutide placebo 16 mg
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Glycated Haemoglobin (HbA1c)
Time frame · Baseline (week 0) and End of treatment (week 40)
Registry description
Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.

Secondary outcomes(3)

Change in Body Weight
Time frame · Baseline (week 0) and End of treatment (week 40)
Registry description
Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame · From baseline (week 0) up to end of study (week 49)
Registry description
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.
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Time frame · From baseline (week 0) up to end of study (week 49)
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (week 0) and End of treatment (week 40)

Change in Glycated Haemoglobin (HbA1c)

Group	Value (Percentage-point of HbA1c)	Spread
Semaglutide 2.0 mg	-1.9	1.1
Semaglutide 8.0 mg	-1.8	1.5
Semaglutide 16.0 mg	-2.1	1.5
Placebo	-1.1	1.3

Secondary and other outcome results(3)

Secondary outcomeMean· Baseline (week 0) and End of treatment (week 40)

Change in Body Weight

Group	Value (Kilogram (kg))	Spread
Semaglutide 2.0 mg	-8.9	8.5
Semaglutide 8.0 mg	-10.1	7.4
Semaglutide 16.0 mg	-13.1	8.4
Placebo	-2.3	4.9

Secondary outcomeNumber· From baseline (week 0) up to end of study (week 49)

Number of Treatment-emergent Adverse Events (TEAEs)

Group	Value (Events)
Semaglutide 2.0 mg	43
Semaglutide 8.0 mg	54
Semaglutide 16.0 mg	55
Placebo	37

Secondary outcomeNumber· From baseline (week 0) up to end of study (week 49)

Number of Treatment-emergent Severe Hypoglycaemic Episodes

Group	Value (Episodes)
Semaglutide 2.0 mg	0
Semaglutide 8.0 mg	0
Semaglutide 16.0 mg	0
Placebo	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Semaglutide 2.0 mgParticipants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.	0 / 60	4 / 60	30 / 60
Semaglutide 8.0 mgParticipants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.	0 / 60	2 / 60	48 / 60
Semaglutide 16.0 mgParticipants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.	0 / 62	1 / 62	50 / 62
PlaceboParticipants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.	0 / 59	2 / 59	29 / 59

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 64 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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