Trial · NCT04017832
A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
NCT04017832, Phase 3, Completed, Novo Nordisk A/S; results first posted 2023-09-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes. Trials, record NCT04017832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04017832
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes
- NCT number
- NCT04017832
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,441 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Oral semaglutide, Sitagliptin, Placebo (oral semaglutide), Placebo (sitagliptin)
- First posted
- 2019-07-12
- Last updated
- 2024-10-01
- Other registries' IDs
- eudract:2018-002589-38
- Results first posted
- 2023-09-29
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | From baseline to week 26 | Change in HbA1c from baseline to week 26 in percentage (%) point of HbA1c is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period and in-trial observation period. On-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. In-trial observation period: the time period where participants were considered to be in the trial, regardless of discontinuation of trial product or initiation of rescue medication. |
| Secondary | Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | From baseline to week 26 | Change in fasting plasma glucose (FPG) from baseline to week 26 in millimole per liter (mmol/l) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | From baseline to week 26 | Change from baseline in mean 7-point SMPG profile at week 26 is presented. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | From baseline to week 26 | Change from baseline in 7-point SMPG: Mean postprandial increment (over all meals) at week 26 is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | At week 26 | Number of participants who achieved HbA1c \<7.0% (53 mmol/mol) (ADA target) is presented in category "Yes" and participants who could not achieve HbA1C \<7.0 (53 mmol/mol) (ADA target) is presented in category "No". The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | At week 26 | Number of participants who achieved HbA1c equal to or below 6.5 percent (48 mmol/mol) (AACE target) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | At week 26 | Number of participants who achieved HbA1c reduction equal to or above 1 percent-point (10.9 mmol/mol) (yes/no) is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Time to Rescue Medication | From baseline to week 31 | Time to rescue medication is presented as the number of participants who had taken rescue medication anytime from baseline to week 31. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | From baseline to week 26 | Change in body weight from baseline to week 26 in kg is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
| Secondary | Percentage Change From Baseline to Week 26 in Body Weight | From baseline to week 26 | Percentage change from baseline to week 26 in body weight is presented. The outcome data was evaluated based on the on-treatment without rescue medication observation period: from date of first dose of trial product following randomization and the end date which was the first date of any of the following: the last dose of trial product plus 3 days or initiation of rescue medication. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | From baseline to week 26 | Full analysis set (FAS) included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure and Number Analyzed: number of participants with available data for each specified category. | Percentage point of HbA1C | MEAN |
| SECONDARY | Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | From baseline to week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | mmol/l | MEAN |
| SECONDARY | Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile | From baseline to week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals) | From baseline to week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | mmol/L | MEAN |
| SECONDARY | Number of Participants Who Achieved HbA1c <7.0 % (53 mmol/Mol) (American Diabetes Association [ADA] Target) (Yes/no) | At week 26 | FAS included all randomised participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved HbA1c Equal to or Below 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no) | At week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved HbA1c Reduction Equal to or Above 1 Percent-point (10.9 mmol/Mol) (Yes/no) | At week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Rescue Medication | From baseline to week 31 | FAS included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) | From baseline to week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | Kilogram | MEAN |
| SECONDARY | Percentage Change From Baseline to Week 26 in Body Weight | From baseline to week 26 | FAS included all randomized participants. Overall Number of Participants Analyzed: participants with available data for this outcome measure. | Percentage change | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group576
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 3 mg | On-treatment observation period | -0.8 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 7 mg | On-treatment observation period | -1.3 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 14 mg | On-treatment observation period | -1.6 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Sitagliptin 100 mg | On-treatment observation period | -0.7 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 3 mg | In-trial observation period | -0.8 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 7 mg | In-trial observation period | -1.3 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Oral Semaglutide 14 mg | In-trial observation period | -1.5 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) | Sitagliptin 100 mg | In-trial observation period | -0.7 | Standard Deviation 1.0 | Percentage point of HbA1C |
| Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | Oral Semaglutide 3 mg | -1.03 | Standard Deviation 2.11 | mmol/l | |
| Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG) | Oral Semaglutide 7 mg | -1.79 | Standard Deviation 2.20 | mmol/l |
1 to 10 of 576Source ClinicalTrials.gov
See all 576 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Semaglutide 3 mg | 361 | |
| Overall Study | STARTED | Oral Semaglutide 7 mg | 360 | |
| Overall Study | STARTED | Oral Semaglutide 14 mg | 361 | |
| Overall Study | STARTED | Sitagliptin 100 mg | 359 | |
| Overall Study | Full Analysis Set | Oral Semaglutide 3 mg | 361 | |
| Overall Study | Full Analysis Set | Oral Semaglutide 7 mg | 360 | |
| Overall Study | Full Analysis Set | Oral Semaglutide 14 mg | 361 | |
| Overall Study | Full Analysis Set | Sitagliptin 100 mg | 359 | |
| Overall Study | Safety Analysis Set | Oral Semaglutide 3 mg | 361 | |
| Overall Study | Safety Analysis Set | Oral Semaglutide 7 mg | 358 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events236
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased appetite | Metabolism and nutrition disorders | Oral Semaglutide 3 mg | 22 | 361 | 22 |
| other | Decreased appetite | Metabolism and nutrition disorders | Oral Semaglutide 7 mg | 30 | 358 | 30 |
| other | Decreased appetite | Metabolism and nutrition disorders | Oral Semaglutide 14 mg | 34 | 361 | 39 |
| other | Decreased appetite | Metabolism and nutrition disorders | Sitagliptin 100 mg | 5 | 358 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Oral Semaglutide 3 mg | 30 | 361 | 31 |
| other | Diarrhoea | Gastrointestinal disorders | Oral Semaglutide 7 mg | 32 | 358 | 40 |
| other | Diarrhoea | Gastrointestinal disorders | Oral Semaglutide 14 mg | 48 | 361 | 57 |
| other | Diarrhoea | Gastrointestinal disorders | Sitagliptin 100 mg | 16 | 358 | 17 |
| other | Lipase increased | Investigations | Oral Semaglutide 3 mg | 15 | 361 | 15 |
| other | Lipase increased | Investigations | Oral Semaglutide 7 mg | 17 | 358 | 22 |
1 to 10 of 236Source ClinicalTrials.gov
See all 236 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Semaglutide 3 mg | 2 | 361 |
| Total, all-cause mortality | Oral Semaglutide 7 mg | 2 | 358 |
| Total, all-cause mortality | Oral Semaglutide 14 mg | 1 | 361 |
| Total, all-cause mortality | Sitagliptin 100 mg | 0 | 358 |
| Total, other adverse events | Oral Semaglutide 3 mg | 109 | 361 |
| Total, other adverse events | Oral Semaglutide 7 mg | 117 | 358 |
| Total, other adverse events | Oral Semaglutide 14 mg | 144 | 361 |
| Total, other adverse events | Sitagliptin 100 mg | 65 | 358 |
| Total, serious adverse events | Oral Semaglutide 3 mg | 16 | 361 |
| Total, serious adverse events | Oral Semaglutide 7 mg | 11 | 358 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38985161 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04017832
GET https://conductscience.org/api/trials/v1/NCT04017832/registered?page=2