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A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IcoSema
Insulin glargine
insulin aspart
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:

  • Male or female and age above or equal to 18 years at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
  • HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.

  • Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening:

    • Metformin
    • Sulfonylureas(a)
    • Meglitinides (glinides)(a)
    • DPP-4 inhibitors(a)
    • Sodium-glucose co-transporter 2 inhibitors
    • Alpha-glucosidase-inhibitors
    • Thiazolidinediones
    • Marketed oral combination products only including the products listed above.

  • Body mass index (BMI) less than or equal to 40.0 kg/m^2.

    1. Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation.

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  • Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids).
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  • Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records.
  • Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
  • Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
  • Chronic heart failure classified as being in New York Heart Association Class IV at screening.
  • Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.

Sites / Locations

  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IcoSema

Insuling glargine/insulin aspart

Arm Description

Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.

Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.

Outcomes

Primary Outcome Measures

Change in HbA1c
Percent-points

Secondary Outcome Measures

Change in body weight
Kg
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Number of episodes
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Percentage of readings
Change in fasting plasma glucose (FPG)
mmol/L
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Score 0-36. The higher the score the greater the satisfaction with treatment.
Number of severe hypoglycaemic episodes (level 3)
Number of episodes
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of episodes
Weekly insulin dose (total)
Units

Full Information

First Posted
August 13, 2021
Last Updated
October 11, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05013229
Brief Title
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)
Official Title
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
November 11, 2023 (Anticipated)
Study Completion Date
November 11, 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 will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IcoSema
Arm Type
Experimental
Arm Description
Participants will receive once weekly subcutaneous (s.c) injections of IcoSema during the 52-week treatment period.
Arm Title
Insuling glargine/insulin aspart
Arm Type
Active Comparator
Arm Description
Participants will receive subcutaneous (s.c) injections of insulin glargine once daily combined with 2-4 times daily injections of insulin aspart.
Intervention Type
Drug
Intervention Name(s)
IcoSema
Intervention Description
Participants will receive a once weekly subcutanous (s.c.) injection of IcoSema, on the same day every week for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Participants will receive a once daily subcutaneous (s.c.) injection of insulin glargine combined with Insulin aspart 2-4 times a day during mealtimes for 52 weeks.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Percent-points
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Kg
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From week 0 (V52) to week 52 (V54)
Title
Time in range 3.9 - 10.0 mmol/L (70 - 180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Description
Percentage of readings
Time Frame
From week 48 (V50) to week 52 (V54)
Title
Time spent more than 10.0 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Description
Percentage of readings
Time Frame
From week 48 (V50) to week 52 (V54)
Title
Time spent less than 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
Description
Percentage of readings
Time Frame
From week 48 (V50) to week 52 (V54)
Title
Change in fasting plasma glucose (FPG)
Description
mmol/L
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Title
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction
Description
Score 0-36. The higher the score the greater the satisfaction with treatment.
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Title
Number of severe hypoglycaemic episodes (level 3)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V56)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V56)
Title
Weekly insulin dose (total)
Description
Units
Time Frame
From week 50 (V52) to week 52 (V54)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female and age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. HbA1c of 7.0-10.0 percentage (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening: Metformin Sulfonylureas(a) Meglitinides (glinides)(a) DPP-4 inhibitors(a) Sodium-glucose co-transporter 2 inhibitors Alpha-glucosidase-inhibitors Thiazolidinediones Marketed oral combination products only including the products listed above. Body mass index (BMI) less than or equal to 40.0 kg/m^2. Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation. Exclusion Criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids). Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. Any episodes of diabetic ketoacidosis within 90 days before screening. As declared by the participant or in the medical records. Presence or history of pancreatitis (acute or chronic) within 180 days before screening. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. Chronic heart failure classified as being in New York Heart Association Class IV at screening. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
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
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
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
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686-6011
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
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
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
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
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
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
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681-1538
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
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
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plzen
State/Province
Czech Republic
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 8
ZIP/Postal Code
18100
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
12000
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHE-sur-YON cedex 9
ZIP/Postal Code
85295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45359
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saint Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1042
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Gandhinagar
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411021
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mohali
State/Province
Punjab
ZIP/Postal Code
160062
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226030
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
ZIP/Postal Code
390013
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Partinico
ZIP/Postal Code
90047
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Sesto San Giovanni (MI)
ZIP/Postal Code
20099
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
State/Province
Miyazaki, Japan
ZIP/Postal Code
880-0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kawagoe-shi
State/Province
Saitama, Japan
ZIP/Postal Code
350-0851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Aichi
ZIP/Postal Code
468-0009
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chiba-shi, Chiba
ZIP/Postal Code
260-0804
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chuo-ku, Tokyo
ZIP/Postal Code
103-0002
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Mito-shi, Ibaraki
ZIP/Postal Code
311-4153
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
569-1045
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seri Manjung
State/Province
Perak
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Sungai Buloh
State/Province
Selangor
ZIP/Postal Code
47000
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Alor Setar
ZIP/Postal Code
05400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Miri, Sarawak
ZIP/Postal Code
98000
Country
Malaysia
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
ZIP/Postal Code
15-435
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-404
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-132
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Kocevje
ZIP/Postal Code
1330
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Koper
ZIP/Postal Code
SI-6000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Ljubljana
ZIP/Postal Code
SI-1000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Murska Sobota
ZIP/Postal Code
SI-9000
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Nova Gorica
ZIP/Postal Code
SI-5290
Country
Slovenia
Facility Name
Novo Nordisk Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Bangkoknoi, Bangkok
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Chiang Mai
State/Province
Mueang Chiang Mai District
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Nakhon Ratchasima
ZIP/Postal Code
30000
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
07058
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Aydin
ZIP/Postal Code
09010
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34400
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)

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