Trial · NCT02607865
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
NCT02607865, Phase 3, Completed, Novo Nordisk A/S; results first posted 2020-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes. Trials, record NCT02607865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
- NCT number
- NCT02607865
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,864 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- semaglutide, sitagliptin, placebo
- First posted
- 2015-11-18
- Last updated
- 2022-07-20
- Other registries' IDs
- eudract:2015-001351-71
- Results first posted
- 2020-02-27
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HbA1c: Week 26 | Week 0, week 26 | Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also 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 | Change in Body Weight: Week 26 | Week 0, week 26 | Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also 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 | Change in HbA1c: Weeks 52 and 78 | Week 0, week 52, week 78 | Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in Body Weight (kg): Weeks 52 and 78 | Week 0, week 52, week 78 | Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in Body Weight (%) | Week 0, week 26, week 52, week 78 | Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in FPG | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in BMI | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in Waist Circumference | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in Total Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
| Secondary | Change in LDL Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes43
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HbA1c: Week 26 | Week 0, week 26 | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Body Weight: Week 26 | Week 0, week 26 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Kg | MEAN |
| SECONDARY | Change in HbA1c: Weeks 52 and 78 | Week 0, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Body Weight (kg): Weeks 52 and 78 | Week 0, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Kg | MEAN |
| SECONDARY | Change in Body Weight (%) | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Percentage change | MEAN |
| SECONDARY | Change in FPG | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | mmol/L | MEAN |
| SECONDARY | Change in BMI | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Kg/m^2 | MEAN |
| SECONDARY | Change in Waist Circumference | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | cm | MEAN |
| SECONDARY | Change in Total Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Ratio of total cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change in LDL Cholesterol (Ratio to Baseline) | Week 0, week 26, week 52, week 78 | Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. | Ratio of LDL cholesterol | GEOMETRIC_MEAN |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 outcomesResults by group1,457
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in HbA1c: Week 26 | Oral Semaglutide 3 mg | In-trial | -0.6 | Standard Deviation 1.0 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Oral Semaglutide 7 mg | In-trial | -1.1 | Standard Deviation 1.1 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Oral Semaglutide 14 mg | In-trial | -1.3 | Standard Deviation 1.0 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Sitagliptin 100 mg | In-trial | -0.8 | Standard Deviation 0.9 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Oral Semaglutide 3 mg | On-treatment without rescue medication | -0.6 | Standard Deviation 1.0 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Oral Semaglutide 7 mg | On-treatment without rescue medication | -1.2 | Standard Deviation 1.1 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Oral Semaglutide 14 mg | On-treatment without rescue medication | -1.4 | Standard Deviation 1.0 | Percentage of HbA1c |
| Change in HbA1c: Week 26 | Sitagliptin 100 mg | On-treatment without rescue medication | -0.8 | Standard Deviation 0.9 | Percentage of HbA1c |
| Change in Body Weight: Week 26 | Oral Semaglutide 3 mg | In-trial | -1.2 | Standard Deviation 3.2 | Kg |
| Change in Body Weight: Week 26 | Oral Semaglutide 7 mg | In-trial | -2.2 | Standard Deviation 3.9 | Kg |
1 to 10 of 1,457Source ClinicalTrials.gov
See all 1,457 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 | 466 | |
| Overall Study | STARTED | Oral Semaglutide 7 mg | 466 | |
| Overall Study | STARTED | Oral Semaglutide 14 mg | 465 | |
| Overall Study | STARTED | Sitagliptin 100 mg | 467 | |
| Overall Study | Full Analysis Set (FAS) | Oral Semaglutide 3 mg | 466 | |
| Overall Study | Full Analysis Set (FAS) | Oral Semaglutide 7 mg | 465 | |
| Overall Study | Full Analysis Set (FAS) | Oral Semaglutide 14 mg | 465 | |
| Overall Study | Full Analysis Set (FAS) | Sitagliptin 100 mg | 467 | |
| Overall Study | Safety Analysis Set (SAS) | Oral Semaglutide 3 mg | 466 | |
| Overall Study | Safety Analysis Set (SAS) | Oral Semaglutide 7 mg | 464 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events796
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Oral Semaglutide 3 mg | 21 | 466 | 29 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Oral Semaglutide 7 mg | 13 | 464 | 17 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Oral Semaglutide 14 mg | 20 | 465 | 25 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Sitagliptin 100 mg | 29 | 466 | 32 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Oral Semaglutide 3 mg | 24 | 466 | 35 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Oral Semaglutide 7 mg | 25 | 464 | 31 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Oral Semaglutide 14 mg | 24 | 465 | 25 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Sitagliptin 100 mg | 29 | 466 | 35 |
| other | Decreased appetite | Metabolism and nutrition disorders | Oral Semaglutide 3 mg | 8 | 466 | 8 |
| other | Decreased appetite | Metabolism and nutrition disorders | Oral Semaglutide 7 mg | 14 | 464 | 15 |
1 to 10 of 796Source ClinicalTrials.gov
See all 796 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 | 5 | 466 |
| Total, all-cause mortality | Oral Semaglutide 7 mg | 4 | 464 |
| Total, all-cause mortality | Oral Semaglutide 14 mg | 1 | 465 |
| Total, all-cause mortality | Sitagliptin 100 mg | 3 | 466 |
| Total, other adverse events | Oral Semaglutide 3 mg | 222 | 466 |
| Total, other adverse events | Oral Semaglutide 7 mg | 234 | 464 |
| Total, other adverse events | Oral Semaglutide 14 mg | 232 | 465 |
| Total, other adverse events | Sitagliptin 100 mg | 239 | 466 |
| Total, serious adverse events | Oral Semaglutide 3 mg | 64 | 466 |
| Total, serious adverse events | Oral Semaglutide 7 mg | 47 | 464 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02607865/registered?page=2