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Trial record 9 of 187 for:    BI10773

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

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ClinicalTrials.gov Identifier: NCT01248364
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Intervention Drug: BI 10773
Enrollment 91
Recruitment Details  
Pre-assignment Details  
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Period Title: Overall Study
Started 32 34 13 12
Completed Acute Phase:Single Dose, Day 1 32 34 13 12
Completed Chronic Phase:28-day Treatment 32 33 13 0
Completed 32 33 13 12
Not Completed 0 1 0 0
Reason Not Completed
Adverse Event             0             1             0             0
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects Total
Hide Arm/Group Description Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form. Total of all reporting groups
Overall Number of Baseline Participants 32 34 13 12 91
Hide Baseline Analysis Population Description
Treated set which included all patients/healthy subjects treated with at least one dose of empagliflozin.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 34 participants 13 participants 12 participants 91 participants
60.1  (7.0) 63.3  (6.5) 50.8  (9.8) 47.7  (2.3) 58.3  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 34 participants 13 participants 12 participants 91 participants
Female
11
  34.4%
10
  29.4%
5
  38.5%
2
  16.7%
28
  30.8%
Male
21
  65.6%
24
  70.6%
8
  61.5%
10
  83.3%
63
  69.2%
1.Primary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Day 1
Hide Description Change from baseline of Fasting Plasma glucose (FPG) 3 hours and 35 minutes before meal at day 1
Time Frame Baseline and day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set which included all patients/healthy subjects with at least one dose of empagliflozin (original result (OR))
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 34 13 12
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.20  (0.12) 0.39  (0.13) -0.96  (0.86) -0.47  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2790
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
-0.16 to 0.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.18
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
2.Primary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Day 28
Hide Description

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

Time Frame Baseline and day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 33 13 0
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-1.02  (0.13) -0.79  (0.15) -0.81  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2438
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.23
Confidence Interval (2-Sided) 95%
-0.16 to 0.62
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.20
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
3.Primary Outcome
Title Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 1
Hide Description 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.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR)
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 34 13 11
Least Squares Mean (Standard Error)
Unit of Measure: g/dL/h
-1.94  (0.53) -3.52  (0.61) -5.49  (1.95) -9.20  (3.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0552
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-3.20 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.81
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
4.Primary Outcome
Title Change From Baseline in Glucose Metabolism (Pre-meal and Postprandial Glucose), PPG iAUC 5h, at Day 28
Hide Description

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.

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR) for patients who completed the day 28 visit
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 33 13 0
Least Squares Mean (Standard Error)
Unit of Measure: g/dL/h
-0.71  (0.67) -0.40  (0.72) -7.31  (2.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7561
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-1.66 to 2.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.99
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
5.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 1
Hide Description Change from baseline in rate of endogenous glucose production (EGP) fast after one dose
Time Frame Baseline and day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR)
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 34 13 12
Least Squares Mean (Standard Error)
Unit of Measure: umol/kgFFM/min
4.21  (0.45) 4.51  (0.60) 3.28  (0.89) 1.10  (0.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6931
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-1.19 to 1.79
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.75
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
6.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: Fast, at Day 28
Hide Description

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.

Time Frame Baseline and day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR) for patients who completed the day 28 visit
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 33 13 0
Least Squares Mean (Standard Error)
Unit of Measure: umol/kgFFM/min
2.79  (0.71) 4.63  (0.86) 1.47  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1028
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.84
Confidence Interval (2-Sided) 95%
-0.38 to 4.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.12
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
7.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 1
Hide Description Change from baseline in the area under the curve of endogenous glucose production (EGP) from 0 to 5 hours (EGP AUC 5h) after meal.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR)
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 34 13 11
Least Squares Mean (Standard Error)
Unit of Measure: g
3.28  (1.80) 8.76  (1.77) 3.70  (2.73) 9.22  (3.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0326
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.48
Confidence Interval (2-Sided) 95%
0.47 to 10.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.52
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
8.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: AUC 5h, at Day 28
Hide Description

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.

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR) for patients who completed the day 28 visit
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 33 13 0
Least Squares Mean (Standard Error)
Unit of Measure: g
1.89  (1.35) 5.02  (1.33) 3.14  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1024
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.13
Confidence Interval (2-Sided) 95%
-0.64 to 6.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.89
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
9.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 1
Hide Description 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.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR)
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 34 13 11
Least Squares Mean (Standard Error)
Unit of Measure: g
-8.52  (1.79) -7.22  (2.33) -3.75  (3.82) 1.28  (4.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6576
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
-4.53 to 7.14
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.93
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
10.Secondary Outcome
Title Change From Baseline in Rate of Endogenous Glucose Production: iAUC 5h, at Day 28
Hide Description

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.

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated set (OR) for patients who completed the day 28 visit
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description:
Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
Overall Number of Participants Analyzed 32 33 13 0
Least Squares Mean (Standard Error)
Unit of Measure: g
-6.95  (2.26) -10.63  (2.50) -0.49  (5.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T2DM Naive, T2DM Metformin
Comments No formal testing, exploratory analysis only.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2795
Comments [Not Specified]
Method ANCOVA
Comments Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.68
Confidence Interval (2-Sided) 95%
-10.41 to 3.05
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.38
Estimation Comments Difference calculated as T2DM metformin minus T2DM Naive
Time Frame From first intake of study drug until 7 days after the last treatment intake, 5 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Hide Arm/Group Description Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days. Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
All-Cause Mortality
T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   1/34 (2.94%)   0/13 (0.00%)   0/12 (0.00%) 
Cardiac disorders         
Myocardial infarction  1  0/32 (0.00%)  1/34 (2.94%)  0/13 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T2DM Naive T2DM Metformin Impaired Glucose Tolerance Healthy Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/32 (25.00%)   5/34 (14.71%)   4/13 (30.77%)   1/12 (8.33%) 
Gastrointestinal disorders         
Dyspepsia  1  0/32 (0.00%)  0/34 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Diarrhoea  1  2/32 (6.25%)  1/34 (2.94%)  0/13 (0.00%)  0/12 (0.00%) 
General disorders         
Fatigue  1  0/32 (0.00%)  0/34 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Thirst  1  1/32 (3.13%)  2/34 (5.88%)  0/13 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  2/32 (6.25%)  1/34 (2.94%)  1/13 (7.69%)  1/12 (8.33%) 
Respiratory tract infection  1  0/32 (0.00%)  0/34 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  2/32 (6.25%)  0/34 (0.00%)  1/13 (7.69%)  0/12 (0.00%) 
Nervous system disorders         
Headache  1  2/32 (6.25%)  1/34 (2.94%)  0/13 (0.00%)  0/12 (0.00%) 
Dizziness  1  2/32 (6.25%)  0/34 (0.00%)  0/13 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01248364     History of Changes
Other Study ID Numbers: 1245.39
2010-018708-99 ( EudraCT Number: EudraCT )
First Submitted: November 24, 2010
First Posted: November 25, 2010
Results First Submitted: August 29, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014