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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

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ClinicalTrials.gov Identifier: NCT05486065
Recruitment Status : Recruiting
First Posted : August 3, 2022
Last Update Posted : March 29, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 8, 2022
Estimated Primary Completion Date : November 6, 2023
Estimated Study Completion Date : December 13, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide 2 mg
Participants will receive once-weekly semaglutide 2 mg subcutaneous (s.c.) injection.
 Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Placebo Comparator: Semaglutide placebo 2 mg
Participants will receive once-weekly semaglutide placebo 2 mg s.c. injection.
 Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Experimental: Semaglutide 8 mg
Participants will receive once-weekly semaglutide 8 mg s.c. injection.
 Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Placebo Comparator: Semaglutide placebo 8 mg
Participants will receive once-weekly semaglutide placebo 8 mg s.c. injection.
 Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Experimental: Semaglutide 16 mg
Participants will receive once-weekly semaglutide 16 mg s.c. injection.
 Drug: Semaglutide
Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
Placebo Comparator: Semaglutide placebo 16 mg
Participants will receive once-weekly semaglutide placebo 16 mg s.c. injection.
 Drug: Placebo
Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]
    Measured as percentage


Secondary Outcome Measures :
  1. Change in Body Weight [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]
    Measured as kilogram

  2. Number of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From baseline (week 0) to end of study (week 49) ]
    Measured as count of events

  3. Number of Treatment-emergent Severe Hypoglycaemic Episodes [ Time Frame: From baseline (week 0) to end of study (week 49) ]
    Measured as number of episodes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05486065


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 2834) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT05486065    
Other Study ID Numbers: NN9535-4984
U1111-1271-9209 ( Other Identifier: World Health Organization (WHO) )
2022-000882-41 ( EudraCT Number )
First Posted: August 3, 2022    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Body Weight