A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination

This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Semaglutide; Drug: Semaglutide/dapagliflozin; Drug: Dapagliflozin

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Novo Nordisk Investigational Site
  • Brandenburg
    • Berlin, Brandenburg, Germany, 14050
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female
• Aged 18-64 years (both inclusive) at the time of signing informed consent.
• Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

• Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method.
• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

• Use of tobacco and nicotine products, defined as any of the below:

  • Smoking more than 5 cigarettes or the equivalent per day
  • Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods

• Blood donation, plasma donation or blood draw, defined as any of the below:

  • In excess of 400 mL within the past 90 days prior to the day of screening
  • In excess of 50 mL within the past 30 days prior to the day of screening
• History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.
• Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 sequence A; Semaglutide followed by Semaglutide/dapagliflozin	Drug: Semaglutide; Tablet given orally
Experimental: Part 1 sequence B; Semaglutide/dapagliflozin followed by Semaglutide	Drug: Semaglutide/dapagliflozin; Tablet given orally
Experimental: Part 2 sequence A; Dapagliflozin followed by Semaglutide/dapagliflozin	Drug: Dapagliflozin; Tablet given orally
Experimental: Part 2 sequence B; Semaglutide/dapagliflozin followed by dapagliflozin	Drug: Semaglutide/dapagliflozin; Tablet given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state	measured in h*nmol/L	From 0 to 24 hours on day 49 and 84 in Part 1
AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state	measured inh*ng/mL	From 0 to 24 hours on day 49 and 98 in Part 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)	measured in nmol/L	From 0 to 24 hours on day 49 and 84 in Part 1
Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state	measured in ng/mL	From 0 to 24 hours on day 49 and 98 in Part 2
tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state	measured in hours	From 0 to 24 hours on day 49 and 84 in Part 1
tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state	measured in hours	From 0 to 24 hours on day 49 and 98 in Part 2

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: NN9917-4751; U1111-1266-4254 (Other Identifier: World Health Organization (WHO)); 2022-500007-52-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No