Trial · NCT01879228
Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
NCT01879228, Not applicable, Completed, University of Pennsylvania; results first posted 2022-02-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Chronic Incretin-based Therapy in Cystic Fibrosis. Trials, record NCT01879228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01879228
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Chronic Incretin-based Therapy in Cystic Fibrosis
- NCT number
- NCT01879228
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Cystic Fibrosis, Pancreatic Insufficiency
- Interventions
- Sitagliptin, Placebo
- First posted
- 2013-06-17
- Last updated
- 2022-03-08
- Results first posted
- 2022-02-09
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Baseline and 6 months | The key endpoint of interest will be the change in second phase insulin response derived from the Glucose-Potentiated Arginine (GPA) test. The GPA test will measure insulin, which will be a measure of pancreatic endocrine function in response to the injection of arginine. Arginine is a naturally occurring amino acid (substance) in the body. It will be given in the veins to make the pancreas secrete insulin. After the first injection of arginine, a glucose infusion will be started in order to raise the level of sugar in the blood to 230 mg/dl. Once the level is achieved, arginine will be injected again and blood samples are measured. After a 2 hour break, the glucose infusion will be started to achieve a blood sugar of 340 mg/dl and the arginine injection will be repeated. Comparison of responses at baseline and after 6 months of incretin-based therapy (Sitagliptin) or placebo will be performed using statistical methods. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Baseline and 6 months | Insulin230 µU/mL | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Sitagliptin | Baseline | 0.11 | Inter-Quartile Range 0.05 to 0.906 | Insulin230 µU/mL |
| Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Placebo | Baseline | 0.055 | Inter-Quartile Range 0.022 to 0.13 | Insulin230 µU/mL |
| Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Sitagliptin | 6 Months | 0.085 | Inter-Quartile Range 0.024 to 0.459 | Insulin230 µU/mL |
| Change in Second-phase Insulin Response Derived From the Glucose-potentiated Arginine Test as a Measure of β-cell Sensitivity to Glucose at Baseline and at 6 Months | Placebo | 6 Months | 0.053 | Inter-Quartile Range 0.025 to 0.128 | Insulin230 µU/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sitagliptin | 13 | |
| Overall Study | STARTED | Placebo | 13 | |
| Overall Study | COMPLETED | Sitagliptin | 12 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events2
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 | Mild allergic reaction to study drug | Skin and subcutaneous tissue disorders | Sitagliptin | 1 | 13 | 1 |
| other | Mild allergic reaction to study drug | Skin and subcutaneous tissue disorders | Placebo | 0 | 13 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sitagliptin | 0 | 13 |
| Total, all-cause mortality | Placebo | 0 | 13 |
| Total, other adverse events | Sitagliptin | 1 | 13 |
| Total, other adverse events | Placebo | 0 | 13 |
| Total, serious adverse events | Sitagliptin | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34406395 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sitagliptin vs Placebo: deaths from any cause | Trial comparisons |
| Sitagliptin vs Placebo: serious adverse events | Trial comparisons |
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/NCT01879228
GET https://conductscience.org/api/trials/v1/NCT01879228/registered