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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to end of study (week 49)
Awards & highlights
Summary
This trial tests semaglutide in different doses to see how well it controls blood sugar and weight in people with type 2 diabetes who are overweight and taking metformin. The medicine is given as an injection under the skin. Semaglutide has been studied extensively for its effectiveness in controlling blood sugar and weight in type 2 diabetes, and it is available in both injectable and oral forms.
Eligible Conditions
- Type 2 Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline (week 0) to end of study (week 49)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of study (week 49)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Glycosylated Haemoglobin (HbA1c)
Secondary study objectives
Change in Body Weight
Number of Treatment-emergent Adverse Events (TEAEs)
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT0418984821%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Semaglutide 8 mgExperimental Treatment1 Intervention
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
Group II: Semaglutide 2 mgExperimental Treatment1 Intervention
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
Group III: Semaglutide 16 mgExperimental Treatment1 Intervention
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
Group IV: Semaglutide placebo 2 mgPlacebo Group1 Intervention
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
Group V: Semaglutide placebo 8 mgPlacebo Group1 Intervention
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
Group VI: Semaglutide placebo 16 mgPlacebo Group1 Intervention
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,825 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,313 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You weigh more than what is considered healthy for your height.Your HbA1c level is between 7.0% and 10.5%.Anyone can participate, regardless of gender.Your diabetic eye condition is not under control, and you have not had a recent eye exam to check for any problems.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.Your kidneys are not working well, as shown by a test called eGFR with a value of less than 30 mL/min/1.73 m² at screening.You have been taking the same amount of metformin every day for at least 90 days before screening.Your HbA1c level is between 7.0% and 10.5%.You have been diagnosed with type 2 diabetes for at least 180 days before the screening.You have a body mass index (BMI) of 27 or higher.You are taking metformin for more than 90 days prior to the day of screening.
Research Study Groups:
This trial has the following groups:- Group 1: Semaglutide 8 mg
- Group 2: Semaglutide 2 mg
- Group 3: Semaglutide placebo 2 mg
- Group 4: Semaglutide placebo 8 mg
- Group 5: Semaglutide 16 mg
- Group 6: Semaglutide placebo 16 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05486065 — Phase 2
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