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Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid

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ClinicalTrials.gov Identifier: NCT00915772
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : July 18, 2012
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Linagliptin + metformin
Drug: Linagliptin+metformin
Drug: Metformin
Enrollment 567
Recruitment Details  
Pre-assignment Details In this study, 567 patients were entered and randomised, but only 566 were treated. Therefore the treated set (TS) comprises 566 patients.
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description Metformin 1000mg monotherapy twice daily Linagliptin 2.5mg and metformin 500mg twice daily Linagliptin 2.5mg and metformin 1000mg twice daily
Period Title: Overall Study
Started 170 225 171
Completed 134 179 142
Not Completed 36 46 29
Reason Not Completed
Adverse Event             12             13             11
Protocol Violation             4             1             2
Lost to Follow-up             1             2             2
Lack of Efficacy             9             15             3
Refused to continue trial medication             6             8             4
Any other reason             4             7             7
Arm/Group Title M1000 L2.5+M500 L2.5+M1000 Total
Hide Arm/Group Description Metformin 1000mg monotherapy twice daily Linagliptin 2.5mg and metformin 500mg twice daily Linagliptin 2.5mg and metformin 1000mg twice daily Total of all reporting groups
Overall Number of Baseline Participants 170 225 171 566
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 170 participants 225 participants 171 participants 566 participants
55.6  (10.7) 56.0  (10.7) 55.7  (10.8) 55.8  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 170 participants 225 participants 171 participants 566 participants
Female
77
  45.3%
105
  46.7%
74
  43.3%
256
  45.2%
Male
93
  54.7%
120
  53.3%
97
  56.7%
310
  54.8%
Body Mass Index (BMI) continuous  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 170 participants 225 participants 171 participants 566 participants
29.33  (5.22) 29.06  (4.95) 28.64  (4.79) 29.01  (4.98)
Baseline weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 170 participants 225 participants 171 participants 566 participants
81.09  (18.92) 79.17  (18.75) 78.62  (16.86) 79.58  (18.25)
Baseline Glycosylated haemoglobin (HbA1c) at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 170 participants 225 participants 171 participants 566 participants
7.48  (0.99) 7.64  (1.04) 7.35  (1.12) 7.50  (1.06)
[1]
Measure Description: Based upon non-missing data, n=559 (5:1:1 missing in each of the groups respectively)
Fasting plasma glucose (FPG) at baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 170 participants 225 participants 171 participants 566 participants
156.585  (39.194) 167.088  (44.633) 153.721  (37.128) 159.868  (41.206)
[1]
Measure Description: Based upon non-missing data, n=544 (6:10:6 missing in each of the groups respectively)
1.Primary Outcome
Title Frequency of Patients With Adverse Events (AEs)
Hide Description This includes any AEs detected during routine physical examination and electrocardiogram (ECG) procedures.
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS): all screened patients who were documented to have taken at lease 1 dose of study drug.
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 170 225 171
Measure Type: Number
Unit of Measure: participant
Patients with any AEs 124 149 132
Patients with severe AEs 4 7 5
Patients with withdrawal due to AEs (from AE page) 10 11 9
2.Primary Outcome
Title Change From Baseline at Week 54 in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description Baseline is defined as Visit 1 of 1218.52.
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS and observed cases (OC)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 164 214 165
Mean (Standard Deviation)
Unit of Measure: mmHg
DBP change from baseline -0.3  (8.5) -0.1  (7.4) 0.3  (8.8)
SBP change from baseline 0.6  (12.2) -0.2  (13.2) 2.2  (13.6)
3.Primary Outcome
Title Change From Baseline at Week 54 in Pulse Rate
Hide Description Baseline is defined as Visit 1 of 1218.52.
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS and observed cases (OC)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 164 214 164
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
0.0  (7.7) 0.6  (8.3) 0.1  (8.3)
4.Primary Outcome
Title Frequency of Patients With Possibly Clinically Significant Abnormal Laboratory Parameters: Haematology
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS and observed cases (OC)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 168 225 170
Measure Type: Number
Unit of Measure: participants
Haematocrit abnormality: <=32% 2 2 0
Haemoglobin abnormality:Female ≤9.5;Male ≤11.5g/dL 7 4 2
Red Blood Cells abnormality: < 3* 10^12/L 0 0 0
White Blood Cells abnormal decrease: < 3 * 10^9/L 0 3 1
White Blood Cells abnormal increase: <20.1*10^9/L 0 1 0
Platelets abnormal decrease: <= 75* 10^9/L 0 0 1
Platelets abnormal increase: >= 700* 10^9/L 0 0 0
5.Primary Outcome
Title Possibly Clinically Significant Abnormal Laboratory Parameters: Clinical Chemistry
Hide Description ULN means upper limit of normal
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS and observed cases (OC). In treatment group L2.5+M500, the number of patients analysed was 224 for lactate dehydrogenase abnormality and total bilirubin abnormality due to anailable data.
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 168 225 171
Measure Type: Number
Unit of Measure: participants
Eosinophils abnormality : ≥ 10% 2 4 6
Sodium abnormal decrease: < 130 mmol/L 0 1 2
Sodium abnormal increase: > 160 mmol/L 1 0 0
Potassium abnormal decrease: < 3 mmol/L 0 0 0
Potassium abnormal increase: > 5.8 mmol/L 2 2 4
Calcium abnormal decrease: < 1.8 mmol/L 2 1 0
Calcium abnormal increase: > 3 mmol/L 0 1 0
Phosphate abnormal decrease: < 0.7 mmol/L 1 0 0
Phosphate abnormal increase: > 1.7 mmol/L 0 2 1
Aspartate Transaminase abnormality: ≥3xULN 3 2 2
Alanine Transaminase (ALT) abnormality: >= 3 x ULN 4 3 2
Alkaline phosphatase abnormality: >= 2 x ULN 1 0 0
γ-glutamyl transpeptidase (GGT) increase:≥3ULN 8 5 7
Lactate dehydrogenase abnormality: >= 3 x ULN 0 0 0
Creatine kinase abnormality: >= 3 x ULN 3 1 2
Amylase: > 1.5 x ULN 2 5 4
Total cholesterol abnormality: > 300 mg/dL 0 0 1
Creatinine abnormality: >= 1.5 mg/dL 0 1 0
Total bilirubin abnormality: >= 2 mg/dL 0 1 0
Triglyceride abnormality: >300 mg/dL 14 14 10
Uric acid abnormality:Female: >10;Male: >11 mg/dL 4 3 6
Albumin abnormality: <2.5 g/dL 0 1 0
Bicarbonate abnormal decrease: <21 mmol/L 0 0 2
6.Primary Outcome
Title Clinical Relevant Drug-related Abnormal Findings in Physical Examination and ECG as Reported as AE
Hide Description Frequency of patients with adverse events by treatment, primary system organ class and preferred term
Time Frame Baseline and drug stop (up to 54 weeks) + 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set (TS)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000 Post-treat
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
7 days follow-up period
Overall Number of Participants Analyzed 170 225 171 566
Measure Type: Number
Unit of Measure: participants
Cardiogenic shock 0 0 1 0
Supraventricular tachycardia 0 0 1 0
7.Secondary Outcome
Title Change in HbA1c From Baseline Over Time
Hide Description HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 1 of 1218.52.
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS (OC) with non-missing data at visit
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 168 225 171
Mean (Standard Deviation)
Unit of Measure: Percentage
Change in HbA1c to week 6 (n=157, 207 and 166) -0.06  (0.41) -0.24  (0.51) -0.26  (0.59)
Change in HbA1c to week 18 (n=136, 184 and 147) -0.08  (0.56) -0.29  (0.79) -0.34  (0.93)
Change in HbA1c to week 30 (n=121, 165 and 134) -0.10  (0.82) -0.41  (0.80) -0.36  (0.87)
Change in HbA1c to week 42 (n=110, 152 and 127) -0.14  (0.78) -0.35  (0.80) -0.28  (1.00)
Change in HbA1c to week 54 (n=98, 132 and 117) -0.06  (0.77) -0.28  (0.86) -0.24  (0.91)
8.Secondary Outcome
Title Number of Patients With HbA1c <7.0% After 54 Weeks
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set with non completers considered as failures (NCF)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 170 225 171
Measure Type: Number
Unit of Measure: participant
No 119 168 104
Yes 51 57 67
9.Secondary Outcome
Title Number of Patients With HbA1c <6.5% Over Time
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set with non completers considered as failures (NCF)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 170 225 171
Measure Type: Number
Unit of Measure: participant
No 148 196 130
Yes 22 29 41
10.Secondary Outcome
Title Number of Patients With HbA1c of at Least <0.5% Over Time
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Set with non completers considered as failures (NCF)
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 170 225 171
Measure Type: Number
Unit of Measure: participant
No 143 176 135
Yes 27 49 36
11.Secondary Outcome
Title Change in FPG From Baseline Over Time
Hide Description Baseline is defined as visit 1 of 1218.52.
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS (OC) with non-missing data at visit
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 168 225 171
Mean (Standard Deviation)
Unit of Measure: mg/dL
Change in FPG to week 2 (n=158, 200 and 158) -4.36  (27.86) -12.22  (28.70) -10.57  (28.15)
Change in FPG to week 6 (n=152, 189 and 157) -4.18  (32.68) -13.28  (27.36) -13.46  (32.97)
Change in FPG to week 18 (n=133, 174 and 142) -1.14  (43.18) -11.76  (33.10) -12.88  (33.74)
Change in FPG to week 30 (n=116, 156 and 130) -7.22  (41.67) -13.49  (33.68) -13.90  (32.07)
Change in FPG to week 42 (n=103, 149 and 124) -7.43  (30.48) -9.46  (33.61) -13.10  (34.96)
Change in FPG to week 54 (n=93, 132 and 115) -6.02  (29.25) -7.24  (36.27) -9.82  (31.83)
12.Secondary Outcome
Title Number of Patients With Rescue Therapy
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 170 225 171
Measure Type: Number
Unit of Measure: Number of patients
No 128 163 147
Yes 42 62 24
13.Secondary Outcome
Title Change in HbA1c From Baseline Over Time
Hide Description HbA1c is measured as a percentage. Thus, this change from baseline reflects the visit HbA1c percent minus the baseline HbA1c percent. Baseline is defined as visit 3 from study 1218.46 (NCT00915772).
Time Frame 78 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Non-switcher set (OC) with non-missing data at visit. Only patients who continued on the same treatment in both studies are included
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description:
Metformin 1000mg monotherapy twice daily
Linagliptin 2.5mg and metformin 500mg twice daily
Linagliptin 2.5mg and metformin 1000mg twice daily
Overall Number of Participants Analyzed 109 113 111
Mean (Standard Deviation)
Unit of Measure: Percentage
Change in HbA1c to week 30 (n=102, 103 and 108) -1.19  (0.98) -1.34  (0.91) -1.74  (0.98)
Change in HbA1c to week 42 (n=90, 92 and 95) -1.16  (0.98) -1.31  (0.99) -1.62  (1.05)
Change in HbA1c to week 54 (n=81, 81 and 87) -1.20  (1.14) -1.41  (1.03) -1.73  (0.99)
Change in HbA1c to week 66 (n=74, 73 and 84) -1.26  (1.02) -1.42  (0.93) -1.65  (1.09)
Change in HbA1c to week 78 (n=66, 66 and 78) -1.25  (0.91) -1.32  (1.06) -1.63  (1.05)
Time Frame 54 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title M1000 L2.5+M500 L2.5+M1000
Hide Arm/Group Description Metformin 1000 mg twice daily Linagliptin 2.5 mg + Metformin 500 mg twice daily Linagliptin 2.5 mg + Metformin 1000 mg twice daily
All-Cause Mortality
M1000 L2.5+M500 L2.5+M1000
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
M1000 L2.5+M500 L2.5+M1000
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/170 (4.12%)   12/225 (5.33%)   14/171 (8.19%) 
Blood and lymphatic system disorders       
Anaemia  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Cardiac disorders       
Acute coronary syndrome  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Acute myocardial infarction  1  1/170 (0.59%)  2/225 (0.89%)  0/171 (0.00%) 
Angina pectoris  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Atrial fibrillation  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Atrial flutter  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Cardiac disorder  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Cardiogenic shock  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Coronary artery disease  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Myocardial ischaemia  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Supraventricular tachycardia  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Congenital, familial and genetic disorders       
Holoprosencephaly  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Eye disorders       
Cataract  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Gastrointestinal disorders       
Haemorrhoids  1  1/170 (0.59%)  0/225 (0.00%)  1/171 (0.58%) 
Hepatobiliary disorders       
Cholecystitis chronic  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Cholelithiasis  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Infections and infestations       
Dacryocystitis  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Febrile infection  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Herpes zoster  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Pneumonia  1  1/170 (0.59%)  0/225 (0.00%)  1/171 (0.58%) 
Urinary tract infection  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Injury, poisoning and procedural complications       
Fall  1  0/170 (0.00%)  1/225 (0.44%)  1/171 (0.58%) 
Head injury  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Hip fracture  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Joint dislocation  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Limb injury  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Rib fracture  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Road traffic accident  1  0/170 (0.00%)  1/225 (0.44%)  2/171 (1.17%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Rotator cuff syndrome  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Renal cancer metastatic  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Nervous system disorders       
Cerebrovascular accident  1  1/170 (0.59%)  0/225 (0.00%)  0/171 (0.00%) 
Convulsion  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Ischaemic stroke  1  0/170 (0.00%)  1/225 (0.44%)  0/171 (0.00%) 
Renal and urinary disorders       
Calculus bladder  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/170 (0.00%)  0/225 (0.00%)  1/171 (0.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
M1000 L2.5+M500 L2.5+M1000
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/170 (37.06%)   87/225 (38.67%)   77/171 (45.03%) 
Gastrointestinal disorders       
Diarrhoea  1  4/170 (2.35%)  8/225 (3.56%)  12/171 (7.02%) 
Infections and infestations       
Nasopharyngitis  1  9/170 (5.29%)  9/225 (4.00%)  12/171 (7.02%) 
Urinary tract infection  1  4/170 (2.35%)  9/225 (4.00%)  9/171 (5.26%) 
Investigations       
Glomerular filtration rate decreased  1  6/170 (3.53%)  14/225 (6.22%)  11/171 (6.43%) 
Glycosylated haemoglobin increased  1  9/170 (5.29%)  12/225 (5.33%)  4/171 (2.34%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  14/170 (8.24%)  18/225 (8.00%)  17/171 (9.94%) 
Hyperglycaemia  1  20/170 (11.76%)  29/225 (12.89%)  11/171 (6.43%) 
Hypoglycaemia  1  4/170 (2.35%)  11/225 (4.89%)  11/171 (6.43%) 
Vascular disorders       
Hypertension  1  9/170 (5.29%)  8/225 (3.56%)  10/171 (5.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Other - 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
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00915772     History of Changes
Other Study ID Numbers: 1218.52
2008-008494-59 ( EudraCT Number: EudraCT )
First Submitted: June 2, 2009
First Posted: June 8, 2009
Results First Submitted: June 13, 2012
Results First Posted: July 18, 2012
Last Update Posted: May 14, 2014