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Trial record 31 of 186 for:    BI10773

Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT02577315
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Empagliflozin
Drug: Metformin
Enrollment 25
Recruitment Details Actual number of subjects enrolled in fact represents entered / randomized subjects due to the study set up.
Pre-assignment Details  
Arm/Group Title Fixed Dose Combination (FDC) / Empagliflozin + Metformin Empagliflozin + Metformin / Fixed Dose Combination (FDC)
Hide Arm/Group Description Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations. Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
Period Title: Treatment Period 1 (4 Days)
Started 12 13
Completed 12 12
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Washout Period (5 Days)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Treatment Period 2 (4 Days)
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Fixed Dose Combination (FDC) / Empagliflozin + Metformin Empagliflozin + Metformin / Fixed Dose Combination (FDC) Total
Hide Arm/Group Description Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations. Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations. Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
Treated set (TS): all subjects who were randomised to study medication and were documented to have received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
24.7  (3.6) 30.4  (7.8) 27.6  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
4
  33.3%
9
  69.2%
13
  52.0%
Male
8
  66.7%
4
  30.8%
12
  48.0%
1.Primary Outcome
Title Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Hide Description Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomol (nmol)* hours (h) / Litre (L)
6147
(5.4%)
6141
(5.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 100.10
Confidence Interval (2-Sided) 90%
97.466 to 102.804
Estimation Comments Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).
2.Primary Outcome
Title Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Hide Description Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram (ng)*h /millilitre (mL)
11912
(13.6%)
12472
(13.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 95.51
Confidence Interval (2-Sided) 90%
89.29 to 102.16
Estimation Comments Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).
3.Primary Outcome
Title Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)
Hide Description Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
660
(10.9%)
642
(10.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 102.71
Confidence Interval (2-Sided) 90%
97.309 to 108.413
Estimation Comments Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).
4.Primary Outcome
Title Maximum Measured Concentration of the Metformin in Plasma (Cmax)
Hide Description Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1452
(11.3%)
1437
(11.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 101.07
Confidence Interval (2-Sided) 90%
95.565 to 106.902
Estimation Comments Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).
5.Secondary Outcome
Title Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Hide Description Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
6280
(5.7%)
6261
(5.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 100.30
Confidence Interval (2-Sided) 90%
97.532 to 103.149
Estimation Comments Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).
6.Secondary Outcome
Title Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
Hide Description Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.
Time Frame PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description:
Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
Overall Number of Participants Analyzed 24 24
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
12428
(24.8%)
13285
(24.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empagliflozin / Metformin (FDC), Empagliflozin + Metformin Free Combination
Comments Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.
Method of Estimation Estimation Parameter Ratio of geometric means
Estimated Value 93.55
Confidence Interval (2-Sided) 90%
82.86 to 105.61
Estimation Comments Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).
Time Frame From first drug administration until 14 days after the last drug administration, up to 27 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Hide Arm/Group Description Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
All-Cause Mortality
Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empagliflozin / Metformin (FDC) Empagliflozin + Metformin Free Combination
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
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
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02577315     History of Changes
Other Study ID Numbers: 1276.27
First Submitted: October 8, 2015
First Posted: October 16, 2015
Results First Submitted: October 7, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016