Comprehensive Add on Study in Japan | NCT01204294 | Trialant
NCT01204294
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Mar 28, 2014Estimated
Enrollment
574Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
Linagliptin
Linagliptin
Metformin
Metformin
Linagliptin
Linagliptin
Linagliptin
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01204294
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1218.78
Secondary IDs
Not provided
Brief Title
Comprehensive Add on Study in Japan
Official Title
An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Feb 2014
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
Sep 2010
Primary Completion Date
Jan 2012Actual
Completion Date
Jan 2012Actual
First Submitted Date
Sep 16, 2010
First Submission Date that Met QC Criteria
Sep 16, 2010
First Posted Date
Sep 17, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2012
Results First Submitted that Met QC Criteria
Dec 18, 2012
Results First Posted Date
Jan 23, 2013Estimated
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
Feb 27, 2014
Last Update Posted Date
Mar 28, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Name
Class
Eli Lilly and Company
INDUSTRY
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 safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.
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
574Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Bigu+Lina
Experimental
biguanide plus linagliptin
Drug: Linagliptin
Glin+Lina
Experimental
glinide plus linagliptin
Drug: Linagliptin
Glit+Lina
Experimental
glitazone plus linagliptin
Drug: Linagliptin
SU+Lina
Experimental
sulfonylurea plus linagliptin
Drug: Linagliptin
A-GI+Lina
Experimental
alpha-glucosidase inhibitor plus linagliptin
Drug: Linagliptin
SU+Met
Active Comparator
sulfonylurea plus metformin
Drug: Metformin
A-GI+Met
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Linagliptin
Drug
Linagliptin once daily
Glin+Lina
Linagliptin
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
The first drug administration through 7 days after the last drug administration, up to 382 days
Secondary Outcomes
Measure
Description
Time Frame
Glycosylated Haemoglobin A1c (HbA1c)
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
Baseline and 52 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug
Exclusion criteria:
Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
Not provided
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
1218.78.008 Boehringer Ingelheim Investigational Site
Akishima, Tokyo
Japan
1218.78.030 Boehringer Ingelheim Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
A total of 618 patients were enrolled in the trial at 43 trial sites, and 37 patients were withdrawn from the trial because of screening failure. 581 patients were entered into the 2-week placebo run-in period, and 7 patients were withdrawn. 574 patients completed the 2-week placebo run-in period and took linagliptin 5 mg or metformin.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Bigu+Lina
biguanide plus linagliptin
FG001
Glin+Lina
glinide plus linagliptin
Periods
Title
Milestones
Reasons Not Completed
Overall Study
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Active Comparator
alpha-glucosidase inhibitor plus metformin
Drug: Metformin
Drug
Linagliptin once daily
Glit+Lina
Metformin
Drug
Metformin twice or three time per day
A-GI+Met
Metformin
Drug
Metformin twice or three time per day
SU+Met
Linagliptin
Drug
Linagliptin once daily
A-GI+Lina
Linagliptin
Drug
Linagliptin once daily
Bigu+Lina
Linagliptin
Drug
Linagliptin once daily
SU+Lina
Amagasaki, Hyogo
Japan
1218.78.017 Boehringer Ingelheim Investigational Site
Annaka, Gunma
Japan
1218.78.006 Boehringer Ingelheim Investigational Site
Aomori, Aomori
Japan
1218.78.007 Boehringer Ingelheim Investigational Site
Aomori, Aomori
Japan
1218.78.009 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1218.78.013 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
Japan
1218.78.032 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
Japan
1218.78.040 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
Japan
1218.78.037 Boehringer Ingelheim Investigational Site
Higashi Osaka, Osaka
Japan
1218.78.043 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
Japan
1218.78.019 Boehringer Ingelheim Investigational Site
Isesaki, Gunma
Japan
1218.78.036 Boehringer Ingelheim Investigational Site
Kashiwara, Osaka
Japan
1218.78.026 Boehringer Ingelheim Investigational Site
Kasugai, Aichi
Japan
1218.78.038 Boehringer Ingelheim Investigational Site
Kawachinagano, Osaka
Japan
1218.78.021 Boehringer Ingelheim Investigational Site
Kitaazumi-gun, Nagano
Japan
1218.78.022 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
Japan
1218.78.033 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
Japan
1218.78.012 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
Japan
1218.78.041 Boehringer Ingelheim Investigational Site
Meguro-ku, Tokyo
Japan
1218.78.034 Boehringer Ingelheim Investigational Site
Morioka, Iwate
Japan
1218.78.035 Boehringer Ingelheim Investigational Site
Morioka, Iwate
Japan
1218.78.018 Boehringer Ingelheim Investigational Site
Moriya, Ibaraki
Japan
1218.78.024 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.78.025 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.78.027 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.78.028 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.78.031 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
Japan
1218.78.039 Boehringer Ingelheim Investigational Site
Oita, Oita
Japan
1218.78.004 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
Japan
1218.78.016 Boehringer Ingelheim Investigational Site
Sagae, Yamagata
Japan
1218.78.001 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.78.020 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.78.042 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
Japan
1218.78.005 Boehringer Ingelheim Investigational Site
Shimajiri-gun, Okinawa
Japan
1218.78.014 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo
Japan
1218.78.002 Boehringer Ingelheim Investigational Site
Shinjyuku-ku. Tokyo
Japan
1218.78.011 Boehringer Ingelheim Investigational Site
Shizuoka, Shizuoka
Japan
1218.78.003 Boehringer Ingelheim Investigational Site
Suita, Osaka
Japan
1218.78.023 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
Japan
1218.78.029 Boehringer Ingelheim Investigational Site
Tokorozawa, Saitama
Japan
1218.78.010 Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki
Japan
1218.78.015 Boehringer Ingelheim Investigational Site
Yamagata, Yamagata
Japan
FG002
Glit+Lina
glitazone plus linagliptin
FG003
SU+Lina
sulfonylurea plus linagliptin
FG004
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
FG005
SU+Met
sulfonylurea plus metformin
FG006
A-GI+Met
alpha-glucosidase inhibitor plus metformin
FG00082 subjects
FG00166 subjects
FG00274 subjects
FG003143 subjects
FG00485 subjects
FG00563 subjects
FG00661 subjects
COMPLETED
FG00079 subjects
FG00158 subjects
FG00269 subjects
FG003132 subjects
FG00483 subjects
FG00558 subjects
FG00659 subjects
NOT COMPLETED
FG0003 subjects
FG0018 subjects
FG0025 subjects
FG00311 subjects
FG0042 subjects
FG0055 subjects
FG0062 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0016 subjects
FG0020 subjects
FG0037 subjects
FG0041 subjects
FG0054 subjects
FG0060 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0022 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Other (house moving)
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Bigu+Lina
biguanide plus linagliptin
BG001
Glin+Lina
glinide plus linagliptin
BG002
Glit+Lina
glitazone plus linagliptin
BG003
SU+Lina
sulfonylurea plus linagliptin
BG004
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
BG005
SU+Met
sulfonylurea plus metformin
BG006
A-GI+Met
alpha-glucosidase inhibitor plus metformin
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00082
BG00166
BG00274
BG003143
BG00485
BG00563
BG00661
BG007574
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.4± 9.9
BG00162.6± 8.8
BG00260.4± 9.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00033
BG00118
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
Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
The treated set (TS) comprised all patients who received at least one dose of randomised study medication in the 52-week treatment period
Posted
Number
Patients
The first drug administration through 7 days after the last drug administration, up to 382 days
ID
Title
Description
OG000
Bigu+Lina
biguanide plus linagliptin
OG001
Glin+Lina
glinide plus linagliptin
OG002
Glit+Lina
glitazone plus linagliptin
OG003
SU+Lina
sulfonylurea plus linagliptin
OG004
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
OG005
SU+Met
sulfonylurea plus metformin
OG006
A-GI+Met
alpha-glucosidase inhibitor plus metformin
Units
Counts
Participants
OG00082
OG00166
OG00274
OG003
Title
Denominators
Categories
Patients with any AE
Title
Measurements
OG00069
OG00155
OG00262
OG003
Secondary
Glycosylated Haemoglobin A1c (HbA1c)
The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.
The full analysis set (FAS) comprised all treated patients who had baseline HbA1c measurement and at least one on-treatment HbA1c measurement available
Posted
Mean
Standard Deviation
Percentage
Baseline and 52 weeks
ID
Title
Description
OG000
Bigu+Lina
biguanide plus linagliptin
OG001
Glin+Lina
glinide plus linagliptin
OG002
Glit+Lina
glitazone plus linagliptin
OG003
SU+Lina
sulfonylurea plus linagliptin
OG004
A-GI+Lina
Time Frame
The first drug administration through 7 days after the last drug administration, up to 382 days
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
Bigu+Lina
biguanide plus linagliptin
8
82
55
82
EG001
Glin+Lina
glinide plus linagliptin
5
66
41
66
EG002
Glit+Lina
glitazone plus linagliptin
2
74
37
74
EG003
SU+Lina
sulfonylurea plus linagliptin
7
143
83
143
EG004
A-GI+Lina
alpha-glucosidase inhibitor plus linagliptin
7
85
54
85
EG005
SU+Met
sulfonylurea plus metformin
5
63
31
63
EG006
A-GI+Met
alpha-glucosidase inhibitor plus metformin
3
61
33
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infectious peritonitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG0030 affected143 at risk
EG0040 affected85 at risk
EG0050 affected63 at risk
EG0060 affected61 at risk
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Haemangioma of liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected82 at risk
EG0011 affected66 at risk
EG0020 affected74 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0001 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Lip and/or oral cavity cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Metastases to lymph nodes
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected82 at risk
EG0010 affected66 at risk
EG0020 affected74 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)