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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Semaglutide 2 mg

Semaglutide placebo 2 mg

Semaglutide 8 mg

Semaglutide placebo 8 mg

Semaglutide 16 mg

Semaglutide placebo 16 mg

Arm Description

Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.

Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.

Participants will receive once-weekly semaglutide 8 mg s.c. injection.

Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.

Participants will receive once-weekly semaglutide 16 mg s.c. injection.

Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c)
Measured as percentage

Secondary Outcome Measures

Change in Body Weight
Measured as kilogram
Number of Treatment-emergent Adverse Events (TEAEs)
Measured as count of events
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Measured as number of episodes

Full Information

First Posted
July 31, 2022
Last Updated
October 23, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05486065
Brief Title
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
November 6, 2023 (Anticipated)
Study Completion Date
December 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide 2 mg
Arm Type
Experimental
Arm Description
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
Arm Title
Semaglutide placebo 2 mg
Arm Type
Placebo Comparator
Arm Description
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
Arm Title
Semaglutide 8 mg
Arm Type
Experimental
Arm Description
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
Arm Title
Semaglutide placebo 8 mg
Arm Type
Placebo Comparator
Arm Description
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
Arm Title
Semaglutide 16 mg
Arm Type
Experimental
Arm Description
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
Arm Title
Semaglutide placebo 16 mg
Arm Type
Placebo Comparator
Arm Description
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c)
Description
Measured as percentage
Time Frame
From baseline (week 0) to end of treatment (week 40)
Secondary Outcome Measure Information:
Title
Change in Body Weight
Description
Measured as kilogram
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Number of Treatment-emergent Adverse Events (TEAEs)
Description
Measured as count of events
Time Frame
From baseline (week 0) to end of study (week 49)
Title
Number of Treatment-emergent Severe Hypoglycaemic Episodes
Description
Measured as number of episodes
Time Frame
From baseline (week 0) to end of study (week 49)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5804
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11528
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-15125
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-17562
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Haidari-Athens
ZIP/Postal Code
GR-12462
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR 54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54635
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54643
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57010
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Szeged
State/Province
Csongrád-Csanád
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Komárom
State/Province
Komárom-Esztergom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szombathely
ZIP/Postal Code
H-9700
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Skierniewice
State/Province
Lodzkie
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-465
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-710
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
State/Province
Podlaskie Voivodeship
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Staszow
State/Province
Świętokrzyskie
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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