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Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

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ClinicalTrials.gov Identifier: NCT01438814
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : June 3, 2014
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: metformin placebo
Drug: linagliptin placebo
Drug: metformin
Drug: linagliptin
Enrollment 689

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description Patients treated with Linagliptin 5mg in combination with metformin once daily. Patients treated with metformin alone twice daily.
Period Title: Overall Study
Started 344 345
Completed 330 331
Not Completed 14 14
Reason Not Completed
Adverse Event             3             3
Protocol Violation             1             2
Lost to Follow-up             4             3
Withdrawal by Subject             4             2
Not specified             2             4
Arm/Group Title Lina 5mg + Met qd Met Bid Total
Hide Arm/Group Description Patients treated with Linagliptin 5mg in combination with metformin once daily. Patients treated with metformin alone twice daily. Total of all reporting groups
Overall Number of Baseline Participants 344 345 689
Hide Baseline Analysis Population Description
Treated set (TS): all patients treated with at least 1 dose of randomised study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 344 participants 345 participants 689 participants
53.1  (10.7) 52.9  (10.7) 53.0  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 345 participants 689 participants
Female
175
  50.9%
187
  54.2%
362
  52.5%
Male
169
  49.1%
158
  45.8%
327
  47.5%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment
Hide Description Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.
Time Frame Baseline and 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Mean (Standard Error)
Unit of Measure: percent
-0.99  (0.05) -0.98  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments One-sided test relative to 0.35
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.13 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8924
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.01
Confidence Interval 95%
-0.13 to 0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment
Hide Description The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 257 306
Measure Type: Number
Unit of Measure: participants
119 148
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8201
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes treatment and continuous baseline HbA1c
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.960
Confidence Interval 95%
0.672 to 1.370
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment
Hide Description Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Measure Type: Number
Unit of Measure: participants
25 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9397
Comments [Not Specified]
Method Regression, Logistic
Comments Model includes treatment and baseline HbA1c.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.022
Confidence Interval (2-Sided) 95%
0.582 to 1.796
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment
Hide Description Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
Time Frame Baseline and 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 with LOCF
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 338
Mean (Standard Error)
Unit of Measure: mg/dL
-24.5  (1.5) -26.6  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3352
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Confidence Interval 95%
-2.1 to 6.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment
Hide Description Patients could experience multiple events, therefore, multiple answers were possible for each patient.
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 73 98
Overall Number of Units Analyzed
Type of Units Analyzed: Events
157 219
Measure Type: Number
Unit of Measure: events
Mild 114 153
Moderate 37 65
Severe 6 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0308
Comments [Not Specified]
Method Fisher Exact
Comments Fishers exact p−value presented due to small cell counts
6.Secondary Outcome
Title Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment
Hide Description The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 154 209
Mean (Standard Error)
Unit of Measure: units on a scale
4.9  (0.2) 4.4  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0545
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Confidence Interval 95%
-0.0 to 1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators
Hide Description The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 291 338
Measure Type: Number
Unit of Measure: participants
83 95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9886
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.997
Confidence Interval 95%
0.689 to 1.445
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)
Hide Description The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 (NCF)
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Measure Type: Number
Unit of Measure: participants
211 257
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2108
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.797
Confidence Interval 95%
0.558 to 1.137
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)
Hide Description The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from the FAS1000 (NCF)
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Measure Type: Number
Unit of Measure: participants
162 187
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9972
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.999
Confidence Interval 95%
0.712 to 1.402
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks
Hide Description The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 (NCF)
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Measure Type: Number
Unit of Measure: participants
194 236
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2816
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.832
Confidence Interval 95%
0.594 to 1.163
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Body Weight by Visit at Week 14
Hide Description Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight
Time Frame Baseline and 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS1000 having values for weight at baseline and week 14.
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 287 324
Mean (Standard Error)
Unit of Measure: kg
-0.44  (0.14) -1.05  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.62
Confidence Interval 95%
0.25 to 0.98
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.19
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks
Hide Description The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 (NCF)
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Measure Type: Number
Unit of Measure: participants
149 175
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lina 5mg + Met qd, Met Bid
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7682
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.951
Confidence Interval 95%
0.681 to 1.328
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in HbA1c Over Time
Hide Description Means are adjusted by treatment and continuous baseline HbA1c
Time Frame Baseline, 2 weeks and 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients from FAS1000 (LOCF)
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description:
Patients treated with Linagliptin 5mg in combination with metformin once daily.
Patients treated with metformin alone twice daily.
Overall Number of Participants Analyzed 298 341
Mean (Standard Error)
Unit of Measure: percent
At week 2 -0.28  (0.02) -0.25  (0.02)
At week 8 -0.84  (0.04) -0.78  (0.04)
Time Frame 14 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lina 5mg + Met qd Met Bid
Hide Arm/Group Description Patients treated with Linagliptin 5mg in combination with metformin once daily. Patients treated with metformin alone twice daily.
All-Cause Mortality
Lina 5mg + Met qd Met Bid
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lina 5mg + Met qd Met Bid
Affected / at Risk (%) Affected / at Risk (%)
Total   2/344 (0.58%)   7/345 (2.03%) 
Gastrointestinal disorders     
Abdominal pain  1  0/344 (0.00%)  1/345 (0.29%) 
Epiploic appendagitis  1  0/344 (0.00%)  1/345 (0.29%) 
Pancreatitis acute  1  1/344 (0.29%)  0/345 (0.00%) 
Hepatobiliary disorders     
Biliary dilatation  1  0/344 (0.00%)  1/345 (0.29%) 
Cholecystitis acute  1  0/344 (0.00%)  1/345 (0.29%) 
Infections and infestations     
Acute tonsillitis  1  0/344 (0.00%)  1/345 (0.29%) 
Appendicitis  1  1/344 (0.29%)  0/345 (0.00%) 
Cellulitis  1  0/344 (0.00%)  2/345 (0.58%) 
Injury, poisoning and procedural complications     
Comminuted fracture  1  0/344 (0.00%)  1/345 (0.29%) 
Road traffic accident  1  0/344 (0.00%)  1/345 (0.29%) 
Nervous system disorders     
Balance disorder  1  0/344 (0.00%)  1/345 (0.29%) 
Dizziness  1  0/344 (0.00%)  1/345 (0.29%) 
Respiratory, thoracic and mediastinal disorders     
Vocal cord leukoplakia  1  0/344 (0.00%)  1/345 (0.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lina 5mg + Met qd Met Bid
Affected / at Risk (%) Affected / at Risk (%)
Total   101/344 (29.36%)   121/345 (35.07%) 
Gastrointestinal disorders     
Abdominal pain  1  23/344 (6.69%)  29/345 (8.41%) 
Diarrhoea  1  62/344 (18.02%)  74/345 (21.45%) 
Nausea  1  23/344 (6.69%)  24/345 (6.96%) 
Infections and infestations     
Urinary tract infection  1  17/344 (4.94%)  34/345 (9.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01438814     History of Changes
Other Study ID Numbers: 1218.60
2011-002276-16 ( EudraCT Number: EudraCT )
First Submitted: September 21, 2011
First Posted: September 22, 2011
Results First Submitted: February 28, 2014
Results First Posted: June 3, 2014
Last Update Posted: November 25, 2014