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A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin Icodec
Semaglutide
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days prior to the day of screening HbA1c from 7.5%-10.5% (58-91 millimoles per mole [mmol/mol]) (both inclusive) Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) >= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses >= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs) Exclusion Criteria: Presence or history of pancreatitis (acute or chronic) within 180 days before screening Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening Planned coronary, carotid or peripheral artery revascularization Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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 SiteRecruiting
  • 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 Type

Experimental

Arm Label

Insulin Icodec + Semaglutide

Arm Description

Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses.

Outcomes

Primary Outcome Measures

Change in glycated haemoglobin (HbA1c)
Measured in percentage (%) points.

Secondary Outcome Measures

Change in mean 7-point self-measured plasma glucose (SMPG) profiles
Measured in millimoles per liter (mmol/L).
Change in mean post-prandial glucose increment (over all meals)
Measured in mmol/L.
Change in fasting plasma glucose (FPG)
Measured in mmol/L.
Number of severe hypoglycaemic episodes (level 3)
Measured in number of episodes.
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 mmol/L [54 milligrams per deciliter {mg/dL}], confirmed by blood glucose [BG] meter)
Measured in number of episodes.
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL]), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Measured as number of episodes.
Change in body weight
Measured in kilograms (Kg).
Relative change in weekly insulin icodec dose
Measured in units (U).

Full Information

First Posted
April 3, 2023
Last Updated
September 28, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05813912
Brief Title
A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
Official Title
A Single Arm Study Investigating the Glycaemic Control and Safety of Adding Semaglutide to Insulin Icodec in Participants With Type 2 Diabetes Qualifying for Treatment Intensification
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2023 (Actual)
Primary Completion Date
September 3, 2024 (Anticipated)
Study Completion Date
July 25, 2025 (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 looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insulin Icodec + Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses.
Intervention Type
Drug
Intervention Name(s)
Insulin Icodec
Intervention Description
Participants will receive subcutaneously insulin icodec once weekly for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks.
Primary Outcome Measure Information:
Title
Change in glycated haemoglobin (HbA1c)
Description
Measured in percentage (%) points.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Secondary Outcome Measure Information:
Title
Change in mean 7-point self-measured plasma glucose (SMPG) profiles
Description
Measured in millimoles per liter (mmol/L).
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Title
Change in mean post-prandial glucose increment (over all meals)
Description
Measured in mmol/L.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Title
Change in fasting plasma glucose (FPG)
Description
Measured in mmol/L.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Title
Number of severe hypoglycaemic episodes (level 3)
Description
Measured in number of episodes.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 mmol/L [54 milligrams per deciliter {mg/dL}], confirmed by blood glucose [BG] meter)
Description
Measured in number of episodes.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L [54 mg/dL]), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Description
Measured as number of episodes.
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 57 (visit 56)
Title
Change in body weight
Description
Measured in kilograms (Kg).
Time Frame
From baseline (time of insulin icodec and semaglutide initiation [week 26, visit 28]) to week 52 (visit 54)
Title
Relative change in weekly insulin icodec dose
Description
Measured in units (U).
Time Frame
From the week prior to intensification, week 25 (visit 27) to week 52 (visit 54)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes (T2D) greater than or equal to (>=) 180 days prior to the day of screening HbA1c from 7.5%-10.5% (58-91 millimoles per mole [mmol/mol]) (both inclusive) Treated with once daily or twice daily basal insulin (minimum of 0.25 international units per kilograms per day (IU/kg/day) or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RA) >= 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses >= 90 days prior to screening: metformin, sulfonylureas, meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose Cotransporter-2 (SGLT2) inhibitors, thiazolidinediones, alpha-glucosidase inhibitors. Oral combination products (for the allowed individual oral anti-diabetic drugs) Exclusion Criteria: Presence or history of pancreatitis (acute or chronic) within 180 days before screening Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and initiation Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening Planned coronary, carotid or peripheral artery revascularization Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
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
Broumov
ZIP/Postal Code
550 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Plzeň 3
ZIP/Postal Code
301 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 4 - Chodov
ZIP/Postal Code
148 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
140 21
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sarawak
State/Province
Miri
ZIP/Postal Code
98000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sungai Buloh
State/Province
Selangor
ZIP/Postal Code
47000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Putrajaya
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gorzow Wielkopolski
State/Province
Lubuskie
ZIP/Postal Code
66-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-261
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-710
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Wierzchoslawice
ZIP/Postal Code
33-122
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Not yet recruiting

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 See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

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