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A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Insuline glargine U100 (reduced)
Insuline glargine U100 (titrated)
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 Mellitus (T2D) mellitus greater than or equal to (>=) 180 days before screening.
  • Glycated haemoglobin (HbA1c) of 7-9 percentage [(53-75 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening.
  • Body mass index (BMI) greater than or equal to (>=) 25 kilograms per meter square (kg/m^2) on the day of screening.
  • Stable daily dose(s) greater than or equal to (>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens:
  • Any metformin formulations greater than or equal to (>=) 1500 milligrams (mg) or maximum tolerated or effective dose.
  • Any metformin combination formulation greater than or equal to (>=) 1500 mg or maximum tolerated or effective dose.

The treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors.

• Treated with once daily insulin glargine Unit 100 injections less than or equal to (<=) 40 units/day greater than or equal to (>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed.

Exclusion Criteria:

  • 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.
  • Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.5 nanomoles per litre (nmol/L) [1.5 nanograms per millilitre (ng/mL)] or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening.
  • Presence or history of pancreatitis (acute or chronic).
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification.
  • Any episodes of diabetic ketoacidosis within 90 days before screening.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insuline glargine U100 (reduced) + semaglutide

Insuline glargine U100 (titrated)

Arm Description

Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).

Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).

Outcomes

Primary Outcome Measures

Change in Glycated Haemoglobin (HbA1c)
Non-inferiority of semaglutide s.c. as add-on to dose-reduced insulin glargine to that of titrated insulin glargine will be assessed based on the clinically acceptable margin of 0.3 percentage (%) for the mean treatment difference in HbA1c. Measured as percentage.

Secondary Outcome Measures

Change in Body Weight
Measured as kilogram
Relative Change in Daily Insulin Dose
Measured as percentage
Change in HbA1c
Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage.
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
The questionnaire has been designed to measure the change in the level of satisfaction with diabetes treatment regimens in participants with diabetes who have had a recent intervention. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. Measured as score on a scale.
Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)
Measured as count of participants
Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)
Measured as count of participants
Participants Achieving: HbA1c less than 7 Percentage (Yes/No)
Measured as count of participants
Number of Severe Hypoglycaemic Episodes (Level 3)
Measured as number of episodes
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter)
Measured as number of episodes
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3)
Measured as number of episodes
Participants Achieving All of The Following Targets: HbA1c Reduced From Baseline by At Least 0.3 %; Insulin Dose Reduced From Baseline; No Hypoglycaemic Episodes; No Weight Gain
No hypoglycaemic episodes defined as less than 3.9 mmol/L [70 milligrams per decilitre (mg/dL)] confirmed by Blood Glucose meter. Outcome measure measured as count of participants.
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
The questionnaire has been designed to measure satisfaction with diabetes treatment regimens in participants with diabetes. The questionnaire contains 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Measured as score on a scale.
Change in Score of Short Form 36 Version 2 (SF-36 v2)
The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.

Full Information

First Posted
August 22, 2022
Last Updated
October 23, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05514535
Brief Title
A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)
Official Title
Efficacy and Safety of Once-weekly Semaglutide S.C. 2.0 mg as Add-on to Dose-reduced Insulin Glargine vs Titrated Insulin Glargine in Participants With Type 2 Diabetes and Overweight
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2022 (Actual)
Primary Completion Date
November 20, 2024 (Anticipated)
Study Completion Date
December 25, 2024 (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 semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Insuline glargine U100 (reduced) + semaglutide
Arm Type
Experimental
Arm Description
Participants will initially receive 0.25 milligrams (mg) once-weekly semaglutide subcutaneously (s.c.) and the dose will be gradually escalated to 2 mg as an add-on to dose-reduced insulin glargine s.c. given once-daily. Insulin glargine U100 will be reduced by 10 U at the initiation of semaglutide and then again at each semaglutide dose escalation. Insulin glargine dose will be adjusted based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values (target SMPG: 4.4-7.2 millimoles per litre (mmol/L)).
Arm Title
Insuline glargine U100 (titrated)
Arm Type
Active Comparator
Arm Description
Participants will receive titrated insuline glargine U100 s.c. once-daily. Insulin glargine U100 dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will receive once-weekly semaglutide s.c. for 40 weeks. Semaglutide 0.25 mg will be given at week 0 and then the dose will be escalated at weeks 4, 8 and 12 to 0.5 mg, 1 mg, 2 mg respectively.
Intervention Type
Drug
Intervention Name(s)
Insuline glargine U100 (reduced)
Intervention Description
Participants will receive insulin glargine U100 s.c. once-daily. Insulin glargine dose will be reduced by 10 U at initiation of semaglutide and then again at each semaglutide dose escalation up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Intervention Type
Drug
Intervention Name(s)
Insuline glargine U100 (titrated)
Intervention Description
Participants will receive titrated insulin glargine U100 s.c. once-daily up to 40 weeks. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.4-7.2 mmol/L).
Primary Outcome Measure Information:
Title
Change in Glycated Haemoglobin (HbA1c)
Description
Non-inferiority of semaglutide s.c. as add-on to dose-reduced insulin glargine to that of titrated insulin glargine will be assessed based on the clinically acceptable margin of 0.3 percentage (%) for the mean treatment difference in HbA1c. 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
Relative Change in Daily Insulin Dose
Description
Measured as percentage
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Change in HbA1c
Description
Superiority of semaglutide s.c. as add-on to dose-reduced insulin glargine versus titrated insulin glargine will be assessed. Measured as percentage.
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Score of Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc)
Description
The questionnaire has been designed to measure the change in the level of satisfaction with diabetes treatment regimens in participants with diabetes who have had a recent intervention. It consists of 8 questions, which are to be answered on a Likert scale from -3 to +3 (-3 = much less satisfied now to +3 = much more satisfied now), with 0 (midpoint), representing no change. Six questions are summed to produce a total treatment satisfaction score. The remaining two questions concern perceived frequency of hyperglycemia and perceived frequency of hypoglycemia, respectively. The DTSQc total treatment satisfaction score ranges from -18 to +18, with higher scores associated with greater treatment satisfaction. Measured as score on a scale.
Time Frame
At end of treatment (week 40)
Title
Participants Achieving: Insulin Dose Equal to 0 Units (Yes/No)
Description
Measured as count of participants
Time Frame
At end of treatment (week 40)
Title
Participants Achieving: Insulin Dose Reduced From Baseline by at Least 50 Percentage (Yes/No)
Description
Measured as count of participants
Time Frame
At end of treatment (week 40)
Title
Participants Achieving: HbA1c less than 7 Percentage (Yes/No)
Description
Measured as count of participants
Time Frame
At end of treatment (week 40)
Title
Number of Severe Hypoglycaemic Episodes (Level 3)
Description
Measured as number of episodes
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 Millimoles Per Litre (mmol/L) [54 Milligrams Per Decilitre (mg/dL)] Confirmed by Blood Glucose Meter)
Description
Measured as number of episodes
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than 3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) or Severe Hypoglycaemic Episodes (Level 3)
Description
Measured as number of episodes
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Participants Achieving All of The Following Targets: HbA1c Reduced From Baseline by At Least 0.3 %; Insulin Dose Reduced From Baseline; No Hypoglycaemic Episodes; No Weight Gain
Description
No hypoglycaemic episodes defined as less than 3.9 mmol/L [70 milligrams per decilitre (mg/dL)] confirmed by Blood Glucose meter. Outcome measure measured as count of participants.
Time Frame
At end of treatment (week 40)
Title
Change in Score of Diabetes Treatment Satisfaction Questionnaire - Status Version (DTSQs)
Description
The questionnaire has been designed to measure satisfaction with diabetes treatment regimens in participants with diabetes. The questionnaire contains 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Measured as score on a scale.
Time Frame
From baseline (week 0) to end of treatment (week 40)
Title
Change in Score of Short Form 36 Version 2 (SF-36 v2)
Description
The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.
Time Frame
From baseline (week 0) to end of treatment (week 40)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Type 2 Diabetes Mellitus (T2D) mellitus greater than or equal to (>=) 180 days before screening. Glycated haemoglobin (HbA1c) of 7-9 percentage [(53-75 millimoles per mole (mmol/mol)] (both inclusive) as assessed by central laboratory on the day of screening. Body mass index (BMI) greater than or equal to (>=) 25 kilograms per meter square (kg/m^2) on the day of screening. Stable daily dose(s) greater than or equal to (>=) 90 days before screening of any of the following anti-diabetic drugs or combination regimens: Any metformin formulations greater than or equal to (>=) 1500 milligrams (mg) or maximum tolerated or effective dose. Any metformin combination formulation greater than or equal to (>=) 1500 mg or maximum tolerated or effective dose. The treatment can be with or without sodium glucose cotransporter 2 (SGLT-2) inhibitors. • Treated with a once daily basal insulin (e.g. insulin glargine Unit 100 or U300, neutral protamine hagedorn (NPH) insulin, insulin detemir, insulin degludec) less than or equal to (<=) 40 units/day (U/day) for greater than or equal to (>=) 90 days before screening. Short-term bolus insulin treatment for a maximum of 14 days before screening is allowed. Exclusion Criteria: 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. Potentially missed diagnosis of Type 1 diabetes (T1D) or latent autoimmune diabetes in adults (LADA) verified by C-peptide less than 0.26 nanomoles per litre (nmol/L) (or 260 picomoles per liter [pmol/L] [0.78 nanograms per millilitre {ng/mL}]) or antibodies to glutamic acid decarboxylase (anti-GAD) greater than 5 units/millilitre, as measured by the central laboratory at screening. Presence or history of pancreatitis (acute or chronic). Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 millilitre per minute per 1.73 meter square at screening as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 classification. Any episodes of diabetic ketoacidosis within 90 days before screening. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
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
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
West Hills
State/Province
California
ZIP/Postal Code
91304
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329-4015
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Hinesville
State/Province
Georgia
ZIP/Postal Code
31313
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405-6901
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51501
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461-4231
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012-4637
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78220
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191-4327
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230-3005
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Pardubice 5
ZIP/Postal Code
530 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Plzen - Vychodni Predmesti
ZIP/Postal Code
326 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
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 8
ZIP/Postal Code
18100
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Alexandroupolis
ZIP/Postal Code
GR-68100
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11528
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Haidari-Athens
ZIP/Postal Code
GR-12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nikaia
ZIP/Postal Code
GR-18454
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54636
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54643
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Latina
State/Province
LT
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Montichiari
ZIP/Postal Code
25018
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Caldas da Rainha
ZIP/Postal Code
2500-176
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1050-099
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410025
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Targoviste
State/Province
Dambovita
ZIP/Postal Code
130086
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430222
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Ploiesti
State/Province
Prahova
ZIP/Postal Code
100018
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300125
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bucuresti
ZIP/Postal Code
040172
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Galati
ZIP/Postal Code
800578
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Iasi
ZIP/Postal Code
700547
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Oradea
ZIP/Postal Code
410001
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Satu-Mare
ZIP/Postal Code
440055
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Targu Mures
ZIP/Postal Code
540098
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
83103
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Individual Site Status
Suspended
Facility Name
Novo Nordisk Investigational Site
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Nove Zamky
ZIP/Postal Code
940 59
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Poprad
ZIP/Postal Code
05801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Prievidza
ZIP/Postal Code
97101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2198
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
Umkomaas
State/Province
KwaZulu-Natal
ZIP/Postal Code
4170
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Novo Nordisk Investigational Site
City
La Roca del Vallés
ZIP/Postal Code
08430
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novo Nordisk Investigational Site
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Novo Nordisk Investigational Site
City
Zaporizhzhia
ZIP/Postal Code
69037
Country
Ukraine
Individual Site Status
Withdrawn

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 Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

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