Japanese P III vs Voglibose and Placebo | NCT00654381 | Trialant
NCT00654381
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jan 27, 2014Estimated
Enrollment
561Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
BI 1356
BI 1356
voglibose placebo
BI 1356 placebo
voglibose
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT00654381
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1218.23
Secondary IDs
Not provided
Brief Title
Japanese P III vs Voglibose and Placebo
Official Title
A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Dec 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2008
Primary Completion Date
Jan 2010Actual
Completion Date
Not provided
First Submitted Date
Apr 3, 2008
First Submission Date that Met QC Criteria
Apr 3, 2008
First Posted Date
Apr 8, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
May 18, 2011
Results First Submitted that Met QC Criteria
Jul 5, 2011
Results First Posted Date
Aug 2, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 11, 2013
Last Update Posted Date
Jan 27, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
561Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
voglibose 0.2 mg three times a day (TID)
Active Comparator
patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
Drug: voglibose
BI 1356 low dose
Experimental
patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
Drug: BI 1356
BI 1356 high dose
Experimental
patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
Drug: BI 1356
placebo
Placebo Comparator
patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
Drug: voglibose placebo
Drug: BI 1356 placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BI 1356
Drug
5 mg/daily
BI 1356 low dose
BI 1356
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in HbA1c at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
12 weeks
Change From Baseline in HbA1c at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
26 weeks
Examination of Long-term Safety of Linagliptin (52-week Treatment)
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Relative Efficacy Response of HbA1c at Week 12
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
12 weeks
Relative Efficacy Response of HbA1c at Week 26
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
Age: >= 20 and <= 80
Body Mass Index (BMI) <= 40 kg/m2
Exclusion criteria:
Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
Impaired hepatic function
History of severe allergy/hypersensitivity
Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
Fasting blood glucose >240 mg/dl (=13.3 mmol/L) at Visits 2 or 3
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1218.23.05 Boehringer Ingelheim Investigational Site
Asahi, Chiba
Japan
1218.23.06 Boehringer Ingelheim Investigational Site
Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
Placebo group has 2 sub-groups, placebo-linagliptin 5mg (from 2nd stage) and placebo-linagliptin 10mg (from 2nd stage).
Both Linagliptin 5 mg and 10 mg groups don't have sub-group. Voglibose group has 2 sub-groups, voglibose-linagliptin 5mg (from 3rd stage) and voglibose-linagliptin 10mg (from 3rd stage).
Recruitment Details
Total 6 groups (including sub-groups in placebo and voglibose groups)
Placebo in Stage 1 - 5 mg in Stage 2 - 5 mg in Stage 3
FG001
Placebo - Linagliptin 5mg - Linagliptin 10mg
Placebo in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
Periods
Title
Milestones
Reasons Not Completed
1st Stage
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
Not provided
Drug
10 mg/daily
BI 1356 high dose
voglibose placebo
Drug
three times daily
placebo
BI 1356 placebo
Drug
once daily
placebo
voglibose
Drug
0.6 mg/daily
voglibose 0.2 mg three times a day (TID)
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
26 weeks
Relative Efficacy Response of HbA1c at Week 52
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
52 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
12 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
26 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
52 weeks
Funabashi, Chiba
Japan
1218.23.21 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
Japan
1218.23.44 Boehringer Ingelheim Investigational Site
Hitachiota, Ibaraki
Japan
1218.23.09 Boehringer Ingelheim Investigational Site
Imizu, Toyama
Japan
1218.23.45 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki
Japan
1218.23.13 Boehringer Ingelheim Investigational Site
Izumisano, Osaka
Japan
1218.23.27 Boehringer Ingelheim Investigational Site
Kariya, Aichi
Japan
1218.23.47 Boehringer Ingelheim Investigational Site
Kitakatsushika-gun, Saitama
Japan
1218.23.39 Boehringer Ingelheim Investigational Site
Kitakyuushuu, Fukuoka
Japan
1218.23.02 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
Japan
1218.23.03 Boehringer Ingelheim Investigational Site
Koriyama, Fukushima
Japan
1218.23.10 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
Japan
1218.23.37 Boehringer Ingelheim Investigational Site
Marugame, Kagawa
Japan
1218.23.38 Boehringer Ingelheim Investigational Site
Marugame, Kagawa
Japan
1218.23.23 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
Japan
1218.23.07 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
Japan
1218.23.25 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.23.26 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.23.28 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.23.29 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.23.30 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.23.04 Boehringer Ingelheim Investigational Site
Naka, Ibaraki
Japan
1218.23.15 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima
Japan
1218.23.34 Boehringer Ingelheim Investigational Site
Nishi-ku, Sakai, Osaka
Japan
1218.23.22 Boehringer Ingelheim Investigational Site
Nishishinjyuku, Shinjyuku-ku, Tokyo
Japan
1218.23.16 Boehringer Ingelheim Investigational Site
Oita, Oita
Japan
1218.23.40 Boehringer Ingelheim Investigational Site
Oita, Oita
Japan
1218.23.36 Boehringer Ingelheim Investigational Site
Okayama, Okayama
Japan
1218.23.11 Boehringer Ingelheim Investigational Site
Osaka, Osaka
Japan
1218.23.12 Boehringer Ingelheim Investigational Site
Osaka, Osaka
Japan
1218.23.32 Boehringer Ingelheim Investigational Site
Osaka, Osaka
Japan
1218.23.33 Boehringer Ingelheim Investigational Site
Osaka, Osaka
Japan
1218.23.35 Boehringer Ingelheim Investigational Site
Osaka, Osaka
Japan
1218.23.17 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.18 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.19 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.41 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.42 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.43 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.23.01 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
Japan
1218.23.20 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
Japan
1218.23.46 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
Japan
1218.23.08 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo
Japan
1218.23.14 Boehringer Ingelheim Investigational Site
Suita, Osaka
Japan
1218.23.31 Boehringer Ingelheim Investigational Site
Takatsuki, Osaka
Japan
1218.23.48 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
Japan
Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.
10 mg in Stage 1 - 10 mg in Stage 2 - 10 mg in Stage 3
FG004
Voglibose - Voglibose - Linagliptin 5mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 5 mg in Stage 3
FG005
Voglibose - Voglibose - Linagliptin 10mg
Voglibose in Stage 1 - Voglibose in Stage 2 - 10 mg in Stage 3
FG00039 subjects
FG00141 subjects
FG002159 subjects
FG003160 subjects
FG00481 subjects
FG00581 subjects
COMPLETED
FG00036 subjects
FG00138 subjects
FG002156 subjects
FG003155 subjects
FG00479 subjects
FG00579 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0035 subjects
FG0042 subjects
FG0052 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0042 subjects
FG0051 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Investigator's decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
2nd Stage
Type
Comment
Milestone Data
STARTED
FG00036 subjects
FG00138 subjects
FG002156 subjects
FG003155 subjects
FG00479 subjects
FG00579 subjects
COMPLETED
FG00034 subjects
FG00138 subjects
FG002153 subjects
FG003151 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG003
Extension Stage
Type
Comment
Milestone Data
STARTED
FG00034 subjects
FG00138 subjects
FG002153 subjects
FG003151 subjects
FG00471 subjects
FG00576 subjects
COMPLETED
FG00033 subjects
FG00136 subjects
FG002142 subjects
FG003142 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG00211 subjects
FG0039 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0029 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
The patients with placebo at the start of randomised study medication
BG001
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
BG002
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
BG003
Voglibose
The patients with voglibose at the start of randomised study medication
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00080
BG001159
BG002160
BG003162
BG004561
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.7± 8.9
BG00160.3± 9.4
BG00261.3± 10
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00148
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in HbA1c at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Posted
Least Squares Mean
Standard Error
Percent
12 weeks
ID
Title
Description
OG000
Placebo
The patients with placebo at the start of randomised study medication
OG001
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG002
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
OG00080
OG001159
OG002157
Title
Denominators
Categories
Title
Measurements
OG0000.63± 0.08
OG001-0.24± 0.06
OG002-0.25± 0.06
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linagliptin 5 mg vs placebo at week 12
ANCOVA
Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
<0.0001
Least Squares Mean Difference
-0.87
Standard Error of the Mean
0.09
2-Sided
95
-1.04
-0.7
No
Superiority or Other
OG000
Primary
Change From Baseline in HbA1c at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.
Posted
Least Squares Mean
Standard Error
Percent
26 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
OG002
Voglibose
The patients with voglibose at the start of randomised study medication
Units
Counts
Participants
Secondary
Relative Efficacy Response of HbA1c at Week 12
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
Placebo
The patients with placebo at the start of randomised study medication
OG001
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG002
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
Secondary
Relative Efficacy Response of HbA1c at Week 26
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward.
Posted
Number
Participants
26 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
OG002
Voglibose
The patients with voglibose at the start of randomised study medication
Units
Counts
Participants
Secondary
Relative Efficacy Response of HbA1c at Week 52
HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52
For the 52-week analysis, it was planed to analyse for Linagliptin 5mg and 10mg. Then the patients with placebo and voglibose were excluded in this analysis. Full analysis set for 52-week treatment period with Last Observation Carried Forward
Posted
Number
Participants
52 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
For the 12-week analysis, it was planed the comparison between Linagliptin and placebo. Then the patients with voglibose were excluded in this analysis.Full analysis set for 12-week treatment period with Last Observation Carried Forward.
Posted
Least Squares Mean
Standard Error
mg/dL
12 weeks
ID
Title
Description
OG000
Placebo
The patients with placebo at the start of randomised study medication
OG001
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG002
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
For the 26-week analysis, it was planed the comparison between Linagliptin and Voglibose. Then the patients with placebo were excluded in this analysis.Full analysis set for 26-week treatment period with Last Observation Carried Forward
Posted
Least Squares Mean
Standard Error
mg/dL
26 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
OG002
Voglibose
The patients with voglibose at the start of randomised study medication
Units
Counts
Participants
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
The patients who had at least one available baseline FPG measurement under the treatment with linagliptin
Posted
Least Squares Mean
Standard Error
mg/dL
52 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
OG000
Primary
Examination of Long-term Safety of Linagliptin (52-week Treatment)
The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks
The patients who received at least one dose of linagliptin 5 mg or linagliptin 10 mg during the randomised treatment period
Posted
Number
participants
52 weeks
ID
Title
Description
OG000
Linagliptin 5mg
The patients with linagliptin 5 mg at the start of randomised study medication
OG001
Linagliptin 10 mg
The patients with linagliptin 10 mg at the start of randomised study medication
Units
Counts
Participants
OG000
Time Frame
52 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (1st Stage)
1
80
23
80
EG001
Linagliptin 5mg (2nd-Extension Stage After Placebo)
3
36
19
36
EG002
Linagliptin 10mg (2nd-Extension Stage After Placebo)
1
38
21
38
EG003
Linagliptin 5mg (1st-2nd-Extension Stage)
14
159
101
159
EG004
Linagliptin 10mg (1st-2nd-Extension Stage)
10
160
107
160
EG005
Voglibose (1st-2nd Stage)
7
162
83
162
EG006
Linagliptin 5mg (Extension Stage After Voglibose)
3
71
28
71
EG007
Linagliptin 10mg (Extension Stage After Voglibose)
3
76
31
76
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG0031 affected159 at risk
EG0040 affected160 at risk
EG0050 affected162 at risk
EG0060 affected71 at risk
EG0070 affected76 at risk
Herpes zoster
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Bladder cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Gastric cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Large intestine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0020 affected38 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Cataract
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0021 affected38 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0020 affected38 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0020 affected38 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Limb deformity
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Airway burns
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG00010 affected80 at risk
EG00110 affected36 at risk
EG0028 affected38 at risk
EG00360 affected159 at risk
EG00457 affected160 at risk
EG00536 affected162 at risk
EG00614 affected71 at risk
EG00716 affected76 at risk
Rhinitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected36 at risk
EG0022 affected38 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected36 at risk
EG0022 affected38 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA Version 12.1
Systematic Assessment
EG0004 affected80 at risk
EG0013 affected36 at risk
EG0020 affected38 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0022 affected38 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0022 affected38 at risk
EG003
Cataract
Eye disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0023 affected38 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0005 affected80 at risk
EG0010 affected36 at risk
EG0024 affected38 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0010 affected36 at risk
EG0022 affected38 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected36 at risk
EG0020 affected38 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0010 affected36 at risk
EG0021 affected38 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0012 affected36 at risk
EG0020 affected38 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected36 at risk
EG0021 affected38 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0002 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 12.1
Systematic Assessment
EG0000 affected80 at risk
EG0012 affected36 at risk
EG0020 affected38 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 12.1
Systematic Assessment
EG0001 affected80 at risk
EG0011 affected36 at risk
EG0022 affected38 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069476
Linagliptin
C102817
voglibose
Ancestor Terms
ID
Term
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D011799
Quinazolines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
71 subjects
FG00576 subjects
8 subjects
FG0053 subjects
3 subjects
FG0047 subjects
FG0052 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Investigator's decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
68 subjects
FG00573 subjects
3 subjects
FG0053 subjects
7 subjects
FG0041 subjects
FG0051 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
Closure of the trial site
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
58.5
± 9.9
BG00460.0± 9.7
48
BG00347
BG004166
Male
BG00057
BG001111
BG002112
BG003115
BG004395
OG002
Linagliptin 10 mg vs placebo at week 12
ANCOVA
Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
<0.0001
Least Squares Mean Difference
-0.88
Standard Error of the Mean
0.09
2-Sided
95
-1.05
-0.71
No
Superiority or Other
OG000159
OG001157
OG002162
Title
Denominators
Categories
Title
Measurements
OG000-0.13± 0.07
OG001-0.19± 0.07
OG0020.19± 0.07
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
0.0003
Least Squares Mean Difference
-0.32
Standard Error of the Mean
0.09
2-Sided
95
-0.49
-0.15
No
Superiority or Other
OG001
OG002
Linagliptin 10 mg vs voglibose at week 26
ANCOVA
Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication
<0.0001
Least Squares Mean Difference
-0.39
Standard Error of the Mean
0.09
2-Sided
95
-0.56
-0.21
No
Superiority or Other
OG00080
OG001159
OG002157
Title
Denominators
Categories
HbA1c <7.0%
Title
Measurements
OG0008
OG00142
OG00256
HbA1c <6.5%
Title
Measurements
OG0000
OG00115
OG00218
HbA1c reduction from baseline ≥0.5%
Title
Measurements
OG0007
OG00191
OG00294
OG000159
OG001157
OG002162
Title
Denominators
Categories
HbA1c <7.0%
Title
Measurements
OG00048
OG00154
OG00236
HbA1c <6.5%
Title
Measurements
OG00015
OG00121
OG0027
HbA1c reduction from baseline ≥0.5%
Title
Measurements
OG00091
OG00184
OG00261
159
OG001157
Title
Denominators
Categories
HbA1c <7.0%
Title
Measurements
OG00038
OG00129
HbA1c <6.5%
Title
Measurements
OG0006
OG00110
HbA1c reduction from baseline ≥0.5%
Title
Measurements
OG00062
OG00162
OG00080
OG001159
OG002160
Title
Denominators
Categories
Title
Measurements
OG0007.4± 2.5
OG001-12.3± 1.9
OG002-13.0± 1.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Linagliptin 5 mg vs placebo at week 12
ANCOVA
Model includes treatment,baseline FPG, and number of previous antidiabetic medication
<0.0001
Least Squares Mean Difference
-19.7
Standard Error of the Mean
2.9
2-Sided
95
-25.4
-14.0
No
Superiority or Other
OG000
OG002
Linagliptin 10 mg vs placebo at week 12
ANCOVA
Model includes treatment,baseline FPG, and number of previous antidiabetic medication
<0.0001
Least Squares Mean Difference
-20.4
Standard Error of the Mean
2.9
2-Sided
95
-26.2
-14.7
No
Superiority or Other
OG000159
OG001160
OG002162
Title
Denominators
Categories
Title
Measurements
OG000-5.0± 2.4
OG001-7.8± 2.4
OG0022.0± 2.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Linagliptin 5 mg vs Voglibose at week 26
ANCOVA
Model includes treatment,baseline FPG, and number of previous antidiabetic medication
0.0239
Least Squares Mean Difference
-6.9
Standard Error of the Mean
3.1
2-Sided
95
-13.0
-0.9
No
Superiority or Other
OG001
OG002
Linagliptin 10 mg vs voglibose at week 26
ANCOVA
Model includes treatment,baseline FPG, and number of previous antidiabetic medication