search
Back to results

Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
semaglutide
semaglutide
oral placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI above or equal to 25 and below or equal to 40 kg/m^2
  • Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening
  • HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive)

Exclusion Criteria:

  • Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Chronic malabsorption, regardless of aetiology
  • History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
  • Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit

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 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
  • 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
  • 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
  • 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
  • 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 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

1:Semaglutide tablets : 2.5 mg

2:Semaglutide tablets: 2.5 mg/5 mg

3:Semaglutide tablets: 5.0 mg/10 mg

4:Semaglutide tablets:5.0 mg/10 mg/20 mg

5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg

7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg

8:Placebo tablets

9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg

Arm Description

2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.

Secondary Outcome Measures

Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Change in Body Weight
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Change in Body Mass Index (BMI)
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Number of Confirmed Hypoglycaemic Episodes Recorded
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

Full Information

First Posted
August 13, 2013
Last Updated
January 14, 2021
Sponsor
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT01923181
Brief Title
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Official Title
Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2, 2013 (Actual)
Primary Completion Date
December 11, 2014 (Actual)
Study Completion Date
December 11, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:Semaglutide tablets : 2.5 mg
Arm Type
Experimental
Arm Description
2.5 mg for 26 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
2:Semaglutide tablets: 2.5 mg/5 mg
Arm Type
Experimental
Arm Description
2.5 mg for 4 weeks, then 5.0 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
3:Semaglutide tablets: 5.0 mg/10 mg
Arm Type
Experimental
Arm Description
5.0 mg for 4 weeks, then 10 mg for 22 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
4:Semaglutide tablets:5.0 mg/10 mg/20 mg
Arm Type
Experimental
Arm Description
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
5:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
Arm Type
Experimental
Arm Description
5.0 mg for 4 weeks, then 10 mg for 4 weeks, then 20 mg for 4 weeks, then 40 mg for 14 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
6:Semaglutide tablets:5.0 mg/10 mg/20 mg/40 mg
Arm Type
Experimental
Arm Description
5.0 mg for 8 weeks, then 10 mg for 8 weeks, then 20 mg for 8 weeks, then 40 mg for 2 weeks All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
7:Semaglutide tablets: 5.0 mg/10 mg/20 mg/40 mg
Arm Type
Experimental
Arm Description
5.0 mg for 2 weeks, then 10 mg for 2 weeks, then 20 mg for 2 weeks, then 40 mg for 20 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
8:Placebo tablets
Arm Type
Placebo Comparator
Arm Description
All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Arm Title
9:Semaglutide injections :0.25 mg/0.50 mg/1.0 mg
Arm Type
Active Comparator
Arm Description
0.25 mg for 4 weeks, then 0.50 mg for 4 weeks, then 1.0 mg for 18 weeks. All arms include 26 weeks of treatment and a 5 week follow-up period. The trial medication will be add-on to metformin therapy or as monotherapy in the case where the subject is treated with diet and exercise alone.
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Once-daily oral administration as tablets.
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
Intervention Type
Drug
Intervention Name(s)
oral placebo
Intervention Description
Once-daily oral administration as tablets.
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Haemoglobin)
Description
Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)
Description
Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time Frame
After 26 weeks of treatment
Title
Change in Body Weight
Description
Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time Frame
Week 0, Week 26
Title
Change in Waist Circumference
Description
Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time Frame
Week 0, week 26
Title
Change in Body Mass Index (BMI)
Description
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Time Frame
Week 0, week 26
Title
Number of Treatment Emergent Adverse Events (TEAEs) Recorded
Description
TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.
Time Frame
Weeks 0-31
Title
Number of Confirmed Hypoglycaemic Episodes Recorded
Description
Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
Time Frame
Weeks 0-31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI above or equal to 25 and below or equal to 40 kg/m^2 Subjects diagnosed with T2D (Type 2 diabetes) treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) Exclusion Criteria: Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants History of chronic pancreatitis or idiopathic acute pancreatitis Chronic malabsorption, regardless of aetiology History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094-5965
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19147
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Humboldt
State/Province
Tennessee
ZIP/Postal Code
38343
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spring Hill
State/Province
Tennessee
ZIP/Postal Code
37174
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
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
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Saint Stefan
ZIP/Postal Code
8511
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1010
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4Z9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 1E2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Stayner
State/Province
Ontario
ZIP/Postal Code
L0M 1S0
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Elsterwerda
ZIP/Postal Code
04910
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
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
Saint Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Speyer
ZIP/Postal Code
67346
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Herzliya
ZIP/Postal Code
46851
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Rishon Le Zion
ZIP/Postal Code
75650
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Ipoh
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kota Bharu
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Penang
ZIP/Postal Code
10450
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seri Manjung
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2090
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Almería
ZIP/Postal Code
04001
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Linköping
ZIP/Postal Code
582 16
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Oskarshamn
ZIP/Postal Code
572 28
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Belfast
ZIP/Postal Code
BT16 1RH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Bexhill-on-Sea
ZIP/Postal Code
TN39 4SP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Chesterfield, Derbyshire
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Crewe
ZIP/Postal Code
CW5 5NX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Hinckley
ZIP/Postal Code
LE10 2SE
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
W6 7HY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29049653
Citation
Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J. Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1460-1470. doi: 10.1001/jama.2017.14752.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

We'll reach out to this number within 24 hrs