Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02106923
Collaborator
Eli Lilly and Company (Industry)
72
1
3
3
24.1
Study Details
Study Description
Brief Summary
The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
Study Start Date
:
Apr 1, 2014
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jul 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High dose, fasted 1 fixed dose combination (FDC) tablet vs 3 single tablets under fasted conditions |
Drug: 10 mg Empagliflozin/1000 mg Metformin XR
Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
Drug: 1 tablet Empagliflozin/2 tablets Metformin XR
Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
|
| Experimental: High dose, fed 1 fixed dose combination (FDC) tablet vs 3 single tablets under fed conditions |
Drug: 1 tablet Empagliflozin/2 tablets Metformin XR
Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
Drug: 10 mg Empagliflozin/1000 mg Metformin XR
Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
|
| Experimental: Low dose, fasted 2 fixed dose combination (FDC) tablets vs 4 single tablets under fasted conditions |
Drug: 1 tablet 10 mg Empagliflozin/3 tablets Metformin XR
Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
Drug: 2 tablets 5 mg Empagliflozin/750 Metformin XR
Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets
|
Outcome Measures
Primary Outcome Measures
- AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
- AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point
- Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Maximum measured concentration of empagliflozin in plasma (Cmax).
- Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Maximum measured concentration of metformin in plasma
Secondary Outcome Measures
- AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
- AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin [1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration]
Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
-
Healthy males or females
-
Age 18-50 years (incl.)
-
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
-
Subjects must be able to understand and comply with study requirements
Exclusion criteria:
Any deviation from healthy condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
Sponsors and Collaborators
- Boehringer Ingelheim
- Eli Lilly and Company
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02106923
Other Study ID Numbers:
- 1276.14
First Posted:
Apr 8, 2014
Last Update Posted:
Mar 9, 2017
Last Verified:
Jan 1, 2017
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted) | Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted) | Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed) | Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed) | Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted) | Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h). | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal. | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal. | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h. |
| Period Title: Overall Study | ||||||
| STARTED | 12 | 12 | 12 | 12 | 12 | 12 |
| COMPLETED | 12 | 12 | 12 | 12 | 12 | 11 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | 1000mg, Fasted | 1000mg, Fed | 1500mg, Fasted | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h). | Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal | Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h | Total of all reporting groups |
| Overall Participants | 24 | 24 | 24 | 72 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
28.5
(8.7)
|
32.4
(9.1)
|
31.3
(8.7)
|
30.7
(8.9)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
16
66.7%
|
16
66.7%
|
16
66.7%
|
48
66.7%
|
| Male |
8
33.3%
|
8
33.3%
|
8
33.3%
|
24
33.3%
|
Outcome Measures
| Title | AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin |
|---|---|
| Description | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [nmol*h/L] |
2630
(18.9)
|
2710
(18.3)
|
2720
(20.5)
|
2710
(19.9)
|
2790
(17.3)
|
2680
(18.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 102.98 | |
| Confidence Interval |
(2-Sided) 90% 100.505 to 105.514 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.014 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 100.25 | |
| Confidence Interval |
(2-Sided) 90% 96.809 to 103.823 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.021 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 96.08 | |
| Confidence Interval |
(2-Sided) 90% 93.507 to 98.721 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.016 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
| Title | AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin |
|---|---|
| Description | Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL] |
7020
(35.2)
|
7170
(36.2)
|
13500
(19.1)
|
13200
(18.8)
|
9860
(26.4)
|
10100
(25.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 102.04 | |
| Confidence Interval |
(2-Sided) 90% 92.30 to 112.81 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 98.93 | |
| Confidence Interval |
(2-Sided) 90% 95.45 to 102.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.02 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0002 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 101.70 | |
| Confidence Interval |
(2-Sided) 90% 93.59 to 110.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.05 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
| Title | AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin |
|---|---|
| Description | Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [nmol*h/L] |
2680
(18.7)
|
2760
(17.9)
|
2790
(21.3)
|
2770
(20.2)
|
2840
(17.4)
|
2740
(19.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 102.88 | |
| Confidence Interval |
(2-Sided) 90% 100.446 to 105.373 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.014 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 100.03 | |
| Confidence Interval |
(2-Sided) 90% 96.448 to 103.738 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.021 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 96.49 | |
| Confidence Interval |
(2-Sided) 90% 93.758 to 99.311 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.017 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
| Title | Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin |
|---|---|
| Description | Maximum measured concentration of empagliflozin in plasma (Cmax). |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [nmol/L] |
377
(22.5)
|
395
(24.6)
|
273
(27.6)
|
277
(31.0)
|
396
(21.9)
|
381
(22.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 104.83 | |
| Confidence Interval |
(2-Sided) 90% 99.522 to 110.412 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.031 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 101.84 | |
| Confidence Interval |
(2-Sided) 90% 95.030 to 109.134 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.041 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 96.03 | |
| Confidence Interval |
(2-Sided) 90% 90.217 to 102.211 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.037 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
| Title | Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin |
|---|---|
| Description | Maximum measured concentration of metformin in plasma |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [ng/mL] |
975
(37.2)
|
964
(39.9)
|
1110
(21.2)
|
1200
(22.7)
|
1220
(32.8)
|
1270
(34.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0027 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 98.94 | |
| Confidence Interval |
(2-Sided) 90% 87.925 to 111.329 |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 1.071 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 108.18 | |
| Confidence Interval |
(2-Sided) 90% 102.792 to 113.859 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.030 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0060 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 103.62 | |
| Confidence Interval |
(2-Sided) 90% 92.116 to 116.559 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.071 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
| Title | AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin |
|---|---|
| Description | Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity |
| Time Frame | 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints. |
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h |
| Measure Participants | 24 | 24 | 24 | 23 | 24 | 23 |
| Geometric Mean (Geometric Coefficient of Variation) [ng*h/mL] |
7480
(37.4)
|
7360
(36.7)
|
13900
(20.7)
|
13600
(20.4)
|
10500
(28.5)
|
10900
(28.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza® (Fasted), Empa/ 1000 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0008 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 98.33 | |
| Confidence Interval |
(2-Sided) 90% 89.13 to 108.47 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted) | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Empa/1000 mg Glumetza ® (Fed), Empa/ 1000 mg Met FDC (Fed) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 98.71 | |
| Confidence Interval |
(2-Sided) 90% 94.77 to 102.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.02 |
|
| Estimation Comments | Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed) | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Empa/ 1500 mg Glumetza® (Fasted), Empa/ 1500 mg Met FDC (Fasted) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Model includes effects for sequence, subjects within sequences, period and treatment. | |
| Statistical Test of Hypothesis | p-Value | 0.0021 |
| Comments | ||
| Method | ANOVA | |
| Comments | P-value for ratio outside interval 80%-125% | |
| Method of Estimation | Estimation Parameter | Adjusted geometric mean ratio (%) |
| Estimated Value | 103.90 | |
| Confidence Interval |
(2-Sided) 90% 94.09 to 114.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.06 |
|
| Estimation Comments | Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted) | |
Adverse Events
| Time Frame | From drug administration until next treatment period or follow-up visit, 10 days | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) | ||||||
| Arm/Group Description | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal | Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h | Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h | ||||||
All Cause Mortality |
||||||||||||
| Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/23 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Empa/1000 mg Glumetza® (Fasted) | Empa/ 1000 mg Met FDC (Fasted) | Empa/1000 mg Glumetza ® (Fed) | Empa/ 1000 mg Met FDC (Fed) | Empa/ 1500 mg Glumetza® (Fasted) | Empa/ 1500 mg Met FDC (Fasted) | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/24 (16.7%) | 5/24 (20.8%) | 4/24 (16.7%) | 4/24 (16.7%) | 6/24 (25%) | 7/23 (30.4%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain | 0/24 (0%) | 1/24 (4.2%) | 0/24 (0%) | 1/24 (4.2%) | 3/24 (12.5%) | 2/23 (8.7%) | ||||||
| Diarrhoea | 2/24 (8.3%) | 2/24 (8.3%) | 0/24 (0%) | 2/24 (8.3%) | 0/24 (0%) | 4/23 (17.4%) | ||||||
| Nausea | 0/24 (0%) | 1/24 (4.2%) | 4/24 (16.7%) | 2/24 (8.3%) | 1/24 (4.2%) | 1/23 (4.3%) | ||||||
| Nervous system disorders | ||||||||||||
| Dizziness | 1/24 (4.2%) | 2/24 (8.3%) | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) | 2/23 (8.7%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Oropharyngeal pain | 2/24 (8.3%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) | 0/23 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02106923
Other Study ID Numbers:
- 1276.14
First Posted:
Apr 8, 2014
Last Update Posted:
Mar 9, 2017
Last Verified:
Jan 1, 2017