Trial · NCT01248364
A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects
NCT01248364, Phase 2, Completed, Boehringer Ingelheim; results first posted 2014-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects. Trials, record NCT01248364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01248364
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects
- NCT number
- NCT01248364
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 91 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- BI 10773
- First posted
- 2010-11-25
- Last updated
- 2014-09-09
- Other registries' IDs
- eudract:2010-018708-99
- Results first posted
- 2014-09-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Fasting Plasma Glucose at Day 1 | Baseline and day 1 | Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1 |
| Primary | Change From Baseline in Fasting Plasma Glucose at Day 28 | Baseline and day 28 | Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 28. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable |
| Primary | Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 | Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours. |
| Primary | Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 | Change from baseline in the incremental area under the curve of postprandial plasma glucose from 0 to 5 hours (PPG iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal plasma glucose at 0 hours. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable. |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1 | Baseline and day 1 | Change from baseline in rate of endogenous glucose production (EGP) fast after one dose |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28 | Baseline and day 28 | Change from baseline in rate of endogenous glucose production (EGP) fast after 28 days of treatment. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable. |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 | Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal. |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 | Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable. |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1 | Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour. |
| Secondary | Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28 | Change from baseline in the incremental area under the curve of endogenous glucose production from 0 to 5 hours (EGP iAUC 5h), defined as the area under the curve of timepoints 0 to 5 hours after meal reduced by the pre-meal endogenous glucose production at 0 hour. Note, healthy subjects only received a single dose of empa so assessments at day 28 are not applicable. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Fasting Plasma Glucose at Day 1 | Baseline and day 1 | Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)) | mmol/L | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Fasting Plasma Glucose at Day 28 | Baseline and day 28 | Treated set, which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR)), for patients who completed the day 28 visit | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1 | Baseline and day 1 | Treated set (OR) | umol/kgFFM/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28 | Baseline and day 28 | Treated set (OR) for patients who completed the day 28 visit | umol/kgFFM/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 | Treated set (OR) | g | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 1 | Treated set (OR) | g/dL/h | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 | Treated set (OR) for patients who completed the day 28 visit | g/dL/h | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after meal at baseline and day 28 | Treated set (OR) for patients who completed the day 28 visit | g | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 1 | Treated set (OR) | g | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28 | 0 minutes (min), 15min, 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 4h 30min and 5h after drug administration at baseline and day 28 | Treated set (OR) for patients who completed the day 28 visit | g | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Day 1 | T2DM Naive | 0.20 | Standard Error 0.12 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 1 | T2DM Metformin | 0.39 | Standard Error 0.13 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 1 | Impaired Glucose Tolerance | -0.96 | Standard Error 0.86 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 1 | Healthy Subjects | -0.47 | Standard Error 0.97 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 28 | T2DM Naive | -1.02 | Standard Error 0.13 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 28 | T2DM Metformin | -0.79 | Standard Error 0.15 | mmol/L | |
| Change From Baseline in Fasting Plasma Glucose at Day 28 | Impaired Glucose Tolerance | -0.81 | Standard Error 1.12 | mmol/L | |
| Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1 | T2DM Naive | 4.21 | Standard Error 0.45 | umol/kgFFM/min | |
| Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1 | T2DM Metformin | 4.51 | Standard Error 0.60 | umol/kgFFM/min | |
| Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1 | Impaired Glucose Tolerance | 3.28 | Standard Error 0.89 | umol/kgFFM/min |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T2DM Naive | 32 | |
| Overall Study | STARTED | T2DM Metformin | 34 | |
| Overall Study | STARTED | Impaired Glucose Tolerance | 13 | |
| Overall Study | STARTED | Healthy Subjects | 12 | |
| Overall Study | Completed Acute Phase:Single Dose, Day 1 | T2DM Naive | 32 | |
| Overall Study | Completed Acute Phase:Single Dose, Day 1 | T2DM Metformin | 34 | |
| Overall Study | Completed Acute Phase:Single Dose, Day 1 | Impaired Glucose Tolerance | 13 | |
| Overall Study | Completed Acute Phase:Single Dose, Day 1 | Healthy Subjects | 12 | |
| Overall Study | Completed Chronic Phase:28-day Treatment | T2DM Naive | 32 | |
| Overall Study | Completed Chronic Phase:28-day Treatment | T2DM Metformin | 33 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events40
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 | Nasopharyngitis | Infections and infestations | T2DM Naive | 2 | 32 | |
| other | Nasopharyngitis | Infections and infestations | T2DM Metformin | 1 | 34 | |
| other | Nasopharyngitis | Infections and infestations | Impaired Glucose Tolerance | 1 | 13 | |
| other | Nasopharyngitis | Infections and infestations | Healthy Subjects | 1 | 12 | |
| other | Respiratory tract infection | Infections and infestations | T2DM Naive | 0 | 32 | |
| other | Respiratory tract infection | Infections and infestations | T2DM Metformin | 0 | 34 | |
| other | Respiratory tract infection | Infections and infestations | Impaired Glucose Tolerance | 1 | 13 | |
| other | Respiratory tract infection | Infections and infestations | Healthy Subjects | 0 | 12 | |
| other | Headache | Nervous system disorders | T2DM Naive | 2 | 32 | |
| other | Headache | Nervous system disorders | T2DM Metformin | 1 | 34 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T2DM Naive | ||
| Total, all-cause mortality | T2DM Metformin | ||
| Total, all-cause mortality | Impaired Glucose Tolerance | ||
| Total, all-cause mortality | Healthy Subjects | ||
| Total, other adverse events | T2DM Naive | 8 | 32 |
| Total, other adverse events | T2DM Metformin | 5 | 34 |
| Total, other adverse events | Impaired Glucose Tolerance | 4 | 13 |
| Total, other adverse events | Healthy Subjects | 1 | 12 |
| Total, serious adverse events | T2DM Naive | 0 | 32 |
| Total, serious adverse events | T2DM Metformin | 1 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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/NCT01248364
GET https://conductscience.org/api/trials/v1/NCT01248364/results?page=2