Trial · NCT00775684
Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
NCT00775684, Not applicable, Completed, University of Pennsylvania; results first posted 2017-12-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass. Trials, record NCT00775684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00775684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass
- NCT number
- NCT00775684
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Pre-diabetes, Type 2 Diabetes
- Interventions
- Exenatide, Sitagliptin, Glimepiride
- First posted
- 2008-10-20
- Last updated
- 2022-06-07
- Results first posted
- 2017-12-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Baseline and 6 months | The acute insulin response to arginine (AIRarg) performed during the 340mg/dl glucose clamp allows for estimation of the the beta-cell secretory capacity (AIRmax) or functional beta-cell mass. Changes from baseline to 6 months of AIRmax were compared across groups |
| Primary | Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL) | Baseline and 6 months | AGRmin is performed during the 340mg/dl glucose clamp allows for estimation of the minimum alpha-cell glucagon secretion. Changes from baseline to 6 months of AGRmin were compared across groups. |
| Secondary | Change in Acute Insulin Response to Arginine. (AIRarg) | Baseline and 6 months | The changes in B-cell insulin secretion, Acute Insulin Response to arginine (AIRarg) after 6 months were compared to baseline AIRarg for each group. Listed below are AIRarg at baseline and 6 months for each group. |
| Secondary | Insulin Sensitivity at Baseline and 6 Months | Baseline and 6 months | Insulin sensitivity (M/I) was determined by dividing the mean glucose infusion rate required during the 230 mg/dL glucose clamp (M) by the mean prestimulus insulin level (I) between 40 and 45 min of the glucose infusion The mean difference after 6 months in insulin sensitivity (M/I) were compared |
| Secondary | PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months | Baseline and 6 months | Between ∼60 and 250 mg/dL, the magnitude of AIRarg is a linear function of the plasma glucose level, so the difference in AIRarg at fasting and 230 mg/dL glucose levels divided by the difference in plasma glucose (ΔAIRarg/ΔPG) gives the glucose-potentiation slope (GPS) (8,24-26). Using the y-intercept (b) from the line created by these two points, the plasma glucose level at which half-maximal insulin secretion is achieved (PG50) is derived from solving the equation 1/2 (AIRmax) = (GPS · PG50) + b, and provides a measure of β-cell sensitivity to glucose The mean difference after 6 months in PG 50 were compared. Listed below are the PG50 values at baseline and 6 months. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Baseline and 6 months | We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months. | μU/ml | MEAN |
| SECONDARY | Change in Acute Insulin Response to Arginine. (AIRarg) | Baseline and 6 months | uU/mL | MEAN | |
| SECONDARY | Insulin Sensitivity at Baseline and 6 Months | Baseline and 6 months | ((mg/kg) /min) /uU/mL | MEAN | |
| SECONDARY | PG 50 (the Plasma Glucose Level at Which Half-maximal Insulin Secretion is Achieved During the Glucose-potentiated Arginine Test) at Baseline and 6 Months | Baseline and 6 months | mg/dL | MEAN | |
| PRIMARY | Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (pg/mL) | Baseline and 6 months | We conducted a randomized controlled trial in 40 adult subjects with early Type 2 diabetes (T2D) who received the~glucagon-like peptide (GLP-1) analog exenatide, the dipeptidyl peptidase IV inhibitor sitagliptin or the sulfonylurea glimepiride as an active comparator insulin secretagogue for 6 months. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Exenatide | Acute Insulin Response (AIRmax)Baseline | 214 | Standard Error 60 | μU/ml |
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Sitagliptin | Acute Insulin Response (AIRmax)Baseline | 149 | Standard Error 20 | μU/ml |
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Glimepiride | Acute Insulin Response (AIRmax)Baseline | 133 | Standard Error 19 | μU/ml |
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Exenatide | Acute Insulin Response (AIRmax) 6 Months | 188.5 | Standard Error 34.6 | μU/ml |
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Sitagliptin | Acute Insulin Response (AIRmax) 6 Months | 158.3 | Standard Error 30.3 | μU/ml |
| Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml) | Glimepiride | Acute Insulin Response (AIRmax) 6 Months | 202.5 | Standard Error 35.1 | μU/ml |
| Change in Acute Insulin Response to Arginine. (AIRarg) | AIRarg Exenatide | Acute Insulin Response (AIRarg) Baseline | 52 | Standard Error 14 | uU/mL |
| Change in Acute Insulin Response to Arginine. (AIRarg) | AIRarg Sitagliptin | Acute Insulin Response (AIRarg) Baseline | 35 | Standard Error 4 | uU/mL |
| Change in Acute Insulin Response to Arginine. (AIRarg) | AIRarg Glimepiride | Acute Insulin Response (AIRarg) Baseline | 44 | Standard Error 6 | uU/mL |
| Change in Acute Insulin Response to Arginine. (AIRarg) | AIRarg Exenatide | Acute Insulin Response (AIRarg) 6 Months | 52 | Standard Error 11 | uU/mL |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Exenatide | 17 | |
| Overall Study | STARTED | Sitagliptin | 13 | |
| Overall Study | STARTED | Glimepiride | 17 | |
| Overall Study | COMPLETED | Exenatide | 14 | |
| Overall Study | COMPLETED | Sitagliptin | 12 | |
| Overall Study | COMPLETED | Glimepiride | 14 | |
| Overall Study | NOT COMPLETED | Exenatide | 3 | |
| Overall Study | NOT COMPLETED | Sitagliptin | 1 | |
| Overall Study | NOT COMPLETED | Glimepiride | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Exenatide | 0 | 17 |
| Total, all-cause mortality | Sitagliptin | 0 | 13 |
| Total, all-cause mortality | Glimepiride | 0 | 17 |
| Total, other adverse events | Exenatide | 0 | 17 |
| Total, other adverse events | Sitagliptin | 0 | 13 |
| Total, other adverse events | Glimepiride | 0 | 17 |
| Total, serious adverse events | Exenatide | 0 | 17 |
| Total, serious adverse events | Sitagliptin | 0 | 13 |
| Total, serious adverse events | Glimepiride | 0 | 17 |
Source ClinicalTrials.gov
Papers7
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
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/NCT00775684
GET https://conductscience.org/api/trials/v1/NCT00775684/results?page=2