30 Week Parallel Group Comparison Study of Linagliptin +... | NCT01183013 | Trialant
NCT01183013
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Oct 20, 2014Estimated
Enrollment
936Actual
Phase
Phase 3
Conditions
Diabetes Mellitus, Type 2
Interventions
Pioglitazone 15 mg
Pioglitazone 45 mg
Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg FDC
Countries
United States
Estonia
Germany
Latvia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01183013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1264.3
Secondary IDs
ID
Type
Description
Link
2008-008127-15
EudraCT Number
EudraCT
Brief Title
30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks
Official Title
A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Oct 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
Aug 2010
Primary Completion Date
Feb 2013Actual
Completion Date
Feb 2013Actual
First Submitted Date
Aug 16, 2010
First Submission Date that Met QC Criteria
Aug 16, 2010
First Posted Date
Aug 17, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 12, 2014
Results First Submitted that Met QC Criteria
Mar 14, 2014
Results First Posted Date
Apr 21, 2014Estimated
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
Oct 9, 2014
Last Update Posted Date
Oct 20, 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 primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.
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
936Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pioglitazone 15 mg
Active Comparator
Pioglitazone Capsules 15 mg once daily
Drug: Pioglitazone 15 mg
Pioglitazone 30 mg
Active Comparator
Pioglitazone Capsules 30 mg once daily
Drug: Pioglitazone 30 mg
Pioglitazone 45 mg
Active Comparator
Pioglitazone Capsules 45 mg once daily
Drug: Pioglitazone 45 mg
Linagliptin 5mg
Active Comparator
Linagliptin 5mg Tablets once daily
Drug: Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg
Experimental
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Drug: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg / Pioglitazone 30 mg
Experimental
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pioglitazone 15 mg
Drug
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Pioglitazone 15 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in HbA1c After 30 Weeks of Treatment.
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Baseline and 30 weeks
Secondary Outcomes
Measure
Description
Time Frame
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Diagnosis of type 2 diabetes mellitus prior to informed consent
Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation
Exclusion criteria:
Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)
Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :
Diagnose of heart failure or history of heart failure
Haemodialysis patients, due to limited experience with pioglitazone
Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
Participation in another trial with an investigational drug within 30 days prior to informed consent
Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures
Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:
are nursing or pregnant or
are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner
Symptomatic gallbladder disease in the last six months
Medical history of pancreatitis.
Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 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
1264.3.01026 Boehringer Ingelheim Investigational Site
Birmingham
Alabama
United States
1264.3.01021 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
After Amendment #5, patients were considered COMPLETED at the end of Part A (30 weeks) or after their next Part B visit (up to 54 weeks) if already in Part B. Before Amendment #5, all patients were considered COMPLETED at the end of Part A + Part B (84 weeks).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pio15/Pio30
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
FG001
Pio30/Pio30
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
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
India
Taiwan
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: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg / Pioglitazone 45 mg
Experimental
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Drug: Linagliptin 5mg / Pioglitazone 45 mg FDC
Pioglitazone 45 mg
Drug
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Pioglitazone 45 mg
Pioglitazone 30 mg
Drug
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 45 mg FDC
Drug
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 30 mg FDC
Drug
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg
Drug
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Linagliptin 5mg
Linagliptin 5mg / Pioglitazone 15 mg FDC
Drug
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
Linagliptin 5mg / Pioglitazone 15 mg
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Baseline and 30 weeks
Time to First Use of Rescue Therapy
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
30 weeks
Montgomery
Alabama
United States
1264.3.01020 Boehringer Ingelheim Investigational Site
Muscle Shoals
Alabama
United States
1264.3.01062 Boehringer Ingelheim Investigational Site
Chandler
Arizona
United States
1264.3.01064 Boehringer Ingelheim Investigational Site
Mesa
Arizona
United States
1264.3.01049 Boehringer Ingelheim Investigational Site
Carmichael
California
United States
1264.3.01078 Boehringer Ingelheim Investigational Site
Chino
California
United States
1264.3.01031 Boehringer Ingelheim Investigational Site
Concord
California
United States
1264.3.01037 Boehringer Ingelheim Investigational Site
Lakewood
California
United States
1264.3.01065 Boehringer Ingelheim Investigational Site
Los Angeles
California
United States
1264.3.01006 Boehringer Ingelheim Investigational Site
Norwalk
California
United States
1264.3.01001 Boehringer Ingelheim Investigational Site
Rancho Cucamonga
California
United States
1264.3.01059 Boehringer Ingelheim Investigational Site
San Diego
California
United States
1264.3.01023 Boehringer Ingelheim Investigational Site
Tarzana
California
United States
1264.3.01016 Boehringer Ingelheim Investigational Site
Tustin
California
United States
1264.3.01058 Boehringer Ingelheim Investigational Site
Valencia
California
United States
1264.3.01083 Boehringer Ingelheim Investigational Site
Westlake Village
California
United States
1264.3.01027 Boehringer Ingelheim Investigational Site
Denver
Colorado
United States
1264.3.01033 Boehringer Ingelheim Investigational Site
Norwalk
Connecticut
United States
1264.3.01035 Boehringer Ingelheim Investigational Site
Boca Raton
Florida
United States
1264.3.01015 Boehringer Ingelheim Investigational Site
Clearwater
Florida
United States
1264.3.01082 Boehringer Ingelheim Investigational Site
Hialeah
Florida
United States
1264.3.01036 Boehringer Ingelheim Investigational Site
Jacksonville
Florida
United States
1264.3.01013 Boehringer Ingelheim Investigational Site
Longwood
Florida
United States
1264.3.01038 Boehringer Ingelheim Investigational Site
Miami
Florida
United States
1264.3.01042 Boehringer Ingelheim Investigational Site
Miami
Florida
United States
1264.3.01079 Boehringer Ingelheim Investigational Site
Miami
Florida
United States
1264.3.01019 Boehringer Ingelheim Investigational Site
Port Orange
Florida
United States
1264.3.01018 Boehringer Ingelheim Investigational Site
Saint Cloud
Florida
United States
1264.3.01009 Boehringer Ingelheim Investigational Site
Tampa
Florida
United States
1264.3.01012 Boehringer Ingelheim Investigational Site
Tampa
Florida
United States
1264.3.01008 Boehringer Ingelheim Investigational Site
Atlanta
Georgia
United States
1264.3.01055 Boehringer Ingelheim Investigational Site
Atlanta
Georgia
United States
1264.3.01061 Boehringer Ingelheim Investigational Site
Atlanta
Georgia
United States
1264.3.01074 Boehringer Ingelheim Investigational Site
Blue Ridge
Georgia
United States
1264.3.01084 Boehringer Ingelheim Investigational Site
Cartersville
Georgia
United States
1264.3.01060 Boehringer Ingelheim Investigational Site
Perry
Georgia
United States
1264.3.01050 Boehringer Ingelheim Investigational Site
Savannah
Georgia
United States
1264.3.01077 Boehringer Ingelheim Investigational Site
Chicago
Illinois
United States
1264.3.01052 Boehringer Ingelheim Investigational Site
Brownsburg
Indiana
United States
1264.3.01075 Boehringer Ingelheim Investigational Site
Evansville
Indiana
United States
1264.3.01076 Boehringer Ingelheim Investigational Site
Evansville
Indiana
United States
1264.3.01073 Boehringer Ingelheim Investigational Site
Franklin
Indiana
United States
1264.3.01002 Boehringer Ingelheim Investigational Site
Wichita
Kansas
United States
1264.3.01007 Boehringer Ingelheim Investigational Site
Wichita
Kansas
United States
1264.3.01010 Boehringer Ingelheim Investigational Site
Lexington
Kentucky
United States
1264.3.01028 Boehringer Ingelheim Investigational Site
New Orleans
Louisiana
United States
1264.3.01029 Boehringer Ingelheim Investigational Site
Sunset
Louisiana
United States
1264.3.01069 Boehringer Ingelheim Investigational Site
Hyattsville
Maryland
United States
1264.3.01066 Boehringer Ingelheim Investigational Site
Southfield
Michigan
United States
1264.3.01057 Boehringer Ingelheim Investigational Site
Great Falls
Montana
United States
1264.3.01045 Boehringer Ingelheim Investigational Site
Burlington
North Carolina
United States
1264.3.01044 Boehringer Ingelheim Investigational Site
Charlotte
North Carolina
United States
1264.3.01022 Boehringer Ingelheim Investigational Site
Zanesville
Ohio
United States
1264.3.01032 Boehringer Ingelheim Investigational Site
Oklahoma City
Oklahoma
United States
1264.3.01051 Boehringer Ingelheim Investigational Site
Fleetwood
Pennsylvania
United States
1264.3.01025 Boehringer Ingelheim Investigational Site
Pittsburgh
Pennsylvania
United States
1264.3.01081 Boehringer Ingelheim Investigational Site
Columbia
South Carolina
United States
1264.3.01003 Boehringer Ingelheim Investigational Site
Greer
South Carolina
United States
1264.3.01011 Boehringer Ingelheim Investigational Site
Kingsport
Tennessee
United States
1264.3.01017 Boehringer Ingelheim Investigational Site
Corpus Christi
Texas
United States
1264.3.01067 Boehringer Ingelheim Investigational Site
Dallas
Texas
United States
1264.3.01004 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1264.3.01039 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1264.3.01041 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1264.3.01047 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1264.3.01070 Boehringer Ingelheim Investigational Site
Houston
Texas
United States
1264.3.01040 Boehringer Ingelheim Investigational Site
Killeen
Texas
United States
1264.3.01048 Boehringer Ingelheim Investigational Site
Midland
Texas
United States
1264.3.01030 Boehringer Ingelheim Investigational Site
New Braunfels
Texas
United States
1264.3.01071 Boehringer Ingelheim Investigational Site
North Richland Hills
Texas
United States
1264.3.01085 Boehringer Ingelheim Investigational Site
Plano
Texas
United States
1264.3.01046 Boehringer Ingelheim Investigational Site
San Antonio
Texas
United States
1264.3.01056 Boehringer Ingelheim Investigational Site
Norfolk
Virginia
United States
1264.3.37207 Boehringer Ingelheim Investigational Site
Harju
Estonia
1264.3.37209 Boehringer Ingelheim Investigational Site
Pärnu
Estonia
1264.3.37201 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37202 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37203 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37204 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37205 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37208 Boehringer Ingelheim Investigational Site
Tallinn
Estonia
1264.3.37206 Boehringer Ingelheim Investigational Site
Tartu
Estonia
1264.3.37210 Boehringer Ingelheim Investigational Site
Viljandi County
Estonia
1264.3.49001 Boehringer Ingelheim Investigational Site
Bad Lauterberg / Harz
Germany
1264.3.49007 Boehringer Ingelheim Investigational Site
Dietzenbach
Germany
1264.3.49002 Boehringer Ingelheim Investigational Site
Dortmund
Germany
1264.3.49009 Boehringer Ingelheim Investigational Site
Essen
Germany
1264.3.49003 Boehringer Ingelheim Investigational Site
Hamburg
Germany
1264.3.49012 Boehringer Ingelheim Investigational Site
Ingelheim
Germany
1264.3.49008 Boehringer Ingelheim Investigational Site
Leipzig
Germany
1264.3.49005 Boehringer Ingelheim Investigational Site
Mainz
Germany
1264.3.49010 Boehringer Ingelheim Investigational Site
Offenbach
Germany
1264.3.49004 Boehringer Ingelheim Investigational Site
Stuhr
Germany
1264.3.37105 Boehringer Ingelheim Investigational Site
Daugavpils
Latvia
1264.3.37112 Boehringer Ingelheim Investigational Site
Daugavpils
Latvia
1264.3.37113 Boehringer Ingelheim Investigational Site
Daugavpils
Latvia
1264.3.37110 Boehringer Ingelheim Investigational Site
Jelgava
Latvia
1264.3.37101 Boehringer Ingelheim Investigational Site
Liepāja
Latvia
1264.3.37106 Boehringer Ingelheim Investigational Site
Ogre
Latvia
1264.3.37104 Boehringer Ingelheim Investigational Site
Riga
Latvia
1264.3.37108 Boehringer Ingelheim Investigational Site
Riga
Latvia
1264.3.37109 Boehringer Ingelheim Investigational Site
Riga
Latvia
1264.3.37111 Boehringer Ingelheim Investigational Site
Riga
Latvia
1264.3.37107 Boehringer Ingelheim Investigational Site
Talsi
Latvia
1264.3.37102 Boehringer Ingelheim Investigational Site
Tukums
Latvia
1264.3.37103 Boehringer Ingelheim Investigational Site
Valmiera
Latvia
1264.3.34013 Boehringer Ingelheim Investigational Site
Badía Del Vallès - Barcelona
Spain
1264.3.34001 Boehringer Ingelheim Investigational Site
Barcelona
Spain
1264.3.34008 Boehringer Ingelheim Investigational Site
Barcelona
Spain
1264.3.34005 Boehringer Ingelheim Investigational Site
Borges Del Camp- Tarragona
Spain
1264.3.34006 Boehringer Ingelheim Investigational Site
Canet de Mar - Barcelona
Spain
1264.3.34010 Boehringer Ingelheim Investigational Site
Centelles - Barcelona
Spain
1264.3.34009 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
Spain
1264.3.34004 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat - Barcelona
Spain
1264.3.34002 Boehringer Ingelheim Investigational Site
Sant Adrià Del Besós- Barcelona
Spain
1264.3.34007 Boehringer Ingelheim Investigational Site
Tarrega - Lleida
Spain
1264.3.34012 Boehringer Ingelheim Investigational Site
Valencia
Spain
1264.3.34011 Boehringer Ingelheim Investigational Site
Vic - Barcelona
Spain
1264.3.44032 Boehringer Ingelheim Investigational Site
Annan
United Kingdom
1264.3.44028 Boehringer Ingelheim Investigational Site
Ash Vale, Aldershot
United Kingdom
1264.3.44029 Boehringer Ingelheim Investigational Site
Baillieston, Glasgow
United Kingdom
1264.3.44008 Boehringer Ingelheim Investigational Site
Balham
United Kingdom
1264.3.44021 Boehringer Ingelheim Investigational Site
Bradford-on-Avon
United Kingdom
1264.3.44019 Boehringer Ingelheim Investigational Site
Burbage
United Kingdom
1264.3.44012 Boehringer Ingelheim Investigational Site
Chesterfield
United Kingdom
1264.3.44027 Boehringer Ingelheim Investigational Site
Chestfield, Whitstable
United Kingdom
1264.3.44011 Boehringer Ingelheim Investigational Site
Chippenham
United Kingdom
1264.3.44033 Boehringer Ingelheim Investigational Site
Johnstone
United Kingdom
1264.3.44007 Boehringer Ingelheim Investigational Site
Midsomer Norton
United Kingdom
1264.3.44034 Boehringer Ingelheim Investigational Site
Paisley
United Kingdom
1264.3.44031 Boehringer Ingelheim Investigational Site
Warminster
United Kingdom
FG002
Pio45/Pio45
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
FG003
Lina5/Lina5
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
FG004
Lina5Pio15/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
FG005
Lina5Pio30/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
FG006
Lina5Pio45/Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
FG000131 subjects
FG001140 subjects
FG002138 subjects
FG003135 subjects
FG004126 subjects
FG005133 subjects
FG006133 subjects
COMPLETED
FG00086 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG001101 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG00297 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG003105 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG00490 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG00588 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
FG00696 subjectsCompleted is first 30 weeks (Part A) or up to 84 weeks in relation to Protocol Amendment #5
NOT COMPLETED
FG00045 subjects
FG00139 subjects
FG00241 subjects
FG00330 subjects
FG00436 subjects
FG00545 subjects
FG00637 subjects
Type
Comment
Reasons
Adverse Event
FG0006 subjects
FG0018 subjects
FG0025 subjects
FG0035 subjects
FG00410 subjects
FG00510 subjects
FG0066 subjects
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
Protocol Violation
FG0005 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0007 subjects
FG0013 subjects
FG0024 subjects
FG0033 subjects
FG004
Withdrawal by Subject
FG0009 subjects
FG00113 subjects
FG00210 subjects
FG0038 subjects
FG004
Reasons other than stated above
FG00015 subjects
FG00111 subjects
FG00217 subjects
FG00312 subjects
FG004
All patients from the Full Analysis Set (FAS) which includes those patients in the treated set who had a baseline HbA1c value and at least one on-treatment HbA1c value.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pio15/Pio30
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
BG001
Pio30/Pio30
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
BG002
Pio45/Pio45
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
BG003
Lina5/Lina5
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
BG004
Lina5Pio15/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
BG005
Lina5Pio30/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
BG006
Lina5Pio45/Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000124
BG001134
BG002134
BG003130
BG004120
BG005125
BG006126
BG007893
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
BG00056.4± 10.4
BG00157.2± 11.1
BG00256.5± 11.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00057
BG00164
BG002
Baseline HbA1c
Mean
Standard Deviation
percent
Title
Denominators
Categories
Title
Measurements
BG0008.33± 0.93
BG0017.99± 0.85
BG002
Baseline fasting plasma glucose (FPG)
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
Title
Measurements
BG000171.3± 39.3
BG001165.8± 40.0
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 After 30 Weeks of Treatment.
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Patients from Full Analysis Set (FAS) with last observation carried forward (LOCF) used to handle missing values at Week 30. FAS is the patient set which includes all patients who were documented to have taken at least one dose of treatment and who had a baseline HbA1c value at at least one on-treatment HbA1c.
Posted
Mean
Standard Error
percent
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.66± 0.09
OG001-0.69± 0.09
OG002-0.87± 0.09
OG003
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
0.1571
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
Mean Difference (Final Values)
-0.17
95
-0.41
0.07
No
Superiority or Other
OG001
OG005
Secondary
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
FAS patients who also had baseline HbA1c>=7%.Non-completers (patients without a value at Week 30) were considered as failures (NCF).
Posted
Number
participants
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
Secondary
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
FAS patients who also had baseline HbA1c >=6.5%. Non-completers (patients without a value at Week 30) were considered as failures (NCF)
Posted
Number
participants
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
Secondary
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
FAS with non-completers (without a value at Week 30) considered as failure
Posted
Number
participants
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
OG004
Lina5Pio15
Secondary
HbA1c Change From Baseline by Visit Over Time
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
Secondary
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Patients from Full Analysis Set (FAS) with a value for FPG at baseline and on-treatment. Last observation carried forward (LOCF) used to handle missing values at Week 30.
Posted
Mean
Standard Error
mg/dL
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
OG004
Secondary
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
Secondary
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
MTT set: This patient set includes those patients in the FAS who had a valid MTT at baseline and at least one valid on-treatment MTT. An MTT is considered valid if both an FPG and a 2-hour PPG value are available.
Posted
Least Squares Mean
Standard Error
mg/dL
Baseline and 30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
Secondary
Time to First Use of Rescue Therapy
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
FAS
Posted
Number
Proportion of participants
30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
Secondary
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
FAS
Posted
Number
participants
30 weeks
ID
Title
Description
OG000
Pio15
Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
OG001
Pio30
Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
OG002
Pio45
Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
OG003
Lina5
Participants treated with linagliptin 5mg once daily for the first 30 weeks
OG004
Lina5Pio15
Time Frame
Up to 85 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
Pio15/Pio30
Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
9
131
57
131
EG001
Pio30/Pio30
Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
9
140
55
140
EG002
Pio45/Pio45
Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
5
138
66
138
EG003
Lina5/Lina5
Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
9
135
57
135
EG004
Lina5Pio15/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
9
126
52
126
EG005
Lina5Pio30/Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
15
133
58
133
EG006
Lina5Pio45/Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
10
133
56
133
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG0030 affected135 at risk
EG0040 affected126 at risk
EG0050 affected133 at risk
EG0060 affected133 at risk
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Atrial fibrillation
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Coronary artery disease
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Myocardial infarction
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Tachycardia
Cardiac disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Basedow's disease
Endocrine disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Retinal artery embolism
Eye disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Constipation
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Diverticulum
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastroduodenitis
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Chest pain
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Fatigue
General disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Cholestasis
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Jaundice
Hepatobiliary disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Appendicitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Device related infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Diverticulitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastroenteritis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pneumonia
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pneumonia legionella
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pyelonephritis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Fall
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Traumatic fracture
Injury, poisoning and procedural complications
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Hairy cell leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pancreatic carcinoma stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Rectosigmoid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Small intestine carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Tumour invasion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Encephalitis
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Peripheral nerve palsy
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Radiculopathy
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0021 affected138 at risk
EG003
Bipolar disorder
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Depression
Psychiatric disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Renal colic
Renal and urinary disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0001 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0011 affected140 at risk
EG0020 affected138 at risk
EG003
Skin necrosis
Skin and subcutaneous tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Gastric bypass
Surgical and medical procedures
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Vascular graft
Surgical and medical procedures
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Aortic stenosis
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Arteriovenous fistula
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Hypertensive crisis
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Peripheral ischaemia
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0010 affected140 at risk
EG0020 affected138 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MEDDRA 15.1
Systematic Assessment
EG0002 affected131 at risk
EG0010 affected140 at risk
EG0025 affected138 at risk
EG0037 affected135 at risk
EG00410 affected126 at risk
EG0052 affected133 at risk
EG0063 affected133 at risk
Oedema
General disorders
MEDDRA 15.1
Systematic Assessment
EG0004 affected131 at risk
EG0011 affected140 at risk
EG0027 affected138 at risk
EG003
Oedema peripheral
General disorders
MEDDRA 15.1
Systematic Assessment
EG00013 affected131 at risk
EG00111 affected140 at risk
EG00211 affected138 at risk
EG003
Bronchitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0005 affected131 at risk
EG0014 affected140 at risk
EG0027 affected138 at risk
EG003
Nasopharyngitis
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0009 affected131 at risk
EG00110 affected140 at risk
EG0024 affected138 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0002 affected131 at risk
EG0016 affected140 at risk
EG0029 affected138 at risk
EG003
Urinary tract infection
Infections and infestations
MEDDRA 15.1
Systematic Assessment
EG0007 affected131 at risk
EG0017 affected140 at risk
EG0028 affected138 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDDRA 15.1
Systematic Assessment
EG0009 affected131 at risk
EG00110 affected140 at risk
EG0025 affected138 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0003 affected131 at risk
EG0015 affected140 at risk
EG0029 affected138 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG00012 affected131 at risk
EG0015 affected140 at risk
EG00210 affected138 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDDRA 15.1
Systematic Assessment
EG0005 affected131 at risk
EG0015 affected140 at risk
EG0025 affected138 at risk
EG003
Dizziness
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0000 affected131 at risk
EG0017 affected140 at risk
EG0023 affected138 at risk
EG003
Headache
Nervous system disorders
MEDDRA 15.1
Systematic Assessment
EG0007 affected131 at risk
EG0017 affected140 at risk
EG0029 affected138 at risk
EG003
Hypertension
Vascular disorders
MEDDRA 15.1
Systematic Assessment
EG00012 affected131 at risk
EG0014 affected140 at risk
EG0027 affected138 at risk
EG003
The study (Part B treatment only) was stopped early by protocol amendment #5, although Part A (time frame for all efficacy outcomes) proceeded to completion
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
D000077205
Pioglitazone
D000069476
Linagliptin
Ancestor Terms
ID
Term
D045162
Thiazolidinediones
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D011799
Quinazolines
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0052 subjects
FG0060 subjects
4 subjects
FG0053 subjects
FG0063 subjects
2 subjects
FG0056 subjects
FG0065 subjects
7 subjects
FG0059 subjects
FG00610 subjects
12 subjects
FG00515 subjects
FG00613 subjects
56.3
± 10.1
BG00457.1± 10.2
BG00556.4± 10.0
BG00660.1± 10.2
BG00757.1± 10.5
66
BG00351
BG00454
BG00561
BG00657
BG007410
Male
BG00067
BG00170
BG00268
BG00379
BG00466
BG00564
BG00669
BG007483
8.12
± 0.87
BG0038.01± 0.88
BG0048.13± 0.94
BG0058.17± 1.07
BG0068.01± 0.81
BG0078.11± 0.91
167.5
± 37.9
BG003161.4± 38.1
BG004167.3± 39.5
BG005168.8± 46.8
BG006162.3± 36.8
BG007166.3± 39.9
130
OG004120
OG005125
OG006126
-0.39
± 0.09
OG004-0.83± 0.09
OG005-1.06± 0.09
OG006-1.28± 0.09
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
0.0016
Mean Difference (Final Values)
-0.37
2-Sided
95
-0.60
-0.14
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
0.0006
Mean Difference (Final Values)
-0.41
2-Sided
95
-0.64
-0.18
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
0.0003
Mean Difference (Final Values)
-0.44
2-Sided
95
-0.67
-0.20
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
<0.0001
Mean Difference (Final Values)
-0.68
2-Sided
95
-0.91
-0.44
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.
<0.0001
Mean Difference (Final Values)
-0.89
2-Sided
95
-1.12
-0.66
No
Superiority or Other
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000121
OG001125
OG002129
OG003124
OG004112
OG005118
OG006121
Title
Denominators
Categories
Title
Measurements
OG00039
OG00155
OG00268
OG00329
OG00445
OG00561
OG00681
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.4639
Odds Ratio (OR)
1.246
95
0.692
2.242
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0546
Odds Ratio (OR)
1.746
95
0.989
3.083
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0254
Odds Ratio (OR)
1.903
95
1.083
3.345
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0009
Odds Ratio (OR)
2.804
95
1.524
5.159
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
5.429
95
2.947
10.001
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
9.614
95
5.187
17.821
No
Superiority or Other
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001132
OG002134
OG003129
OG004120
OG005123
OG006125
Title
Denominators
Categories
Title
Measurements
OG00020
OG00128
OG00239
OG00314
OG00424
OG00538
OG00643
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.7359
Odds Ratio (OR)
1.126
95
0.565
2.243
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0363
Odds Ratio (OR)
1.905
95
1.042
3.484
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.4039
Odds Ratio (OR)
1.269
95
0.726
2.217
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0345
Odds Ratio (OR)
2.220
95
1.060
4.649
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
4.580
95
2.263
9.266
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
5.066
95
2.530
10.145
No
Superiority or Other
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003130
OG004120
OG005125
OG006126
Title
Denominators
Categories
Title
Measurements
OG00079
OG00183
OG00290
OG00354
OG00479
OG00591
OG006107
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.7540
Odds Ratio (OR)
1.090
95
0.637
1.863
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0506
Odds Ratio (OR)
1.707
95
0.999
2.918
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0005
Odds Ratio (OR)
2.966
2-Sided
95
1.604
5.485
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0002
Odds Ratio (OR)
2.696
95
1.594
4.559
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
4.017
95
2.348
6.873
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
<0.0001
Odds Ratio (OR)
8.521
95
4.630
15.681
No
Superiority or Other
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003130
OG004120
OG005125
OG006126
Title
Denominators
Categories
Change to week 6 (N=121,133,133,130,119,124,125)
Title
Measurements
OG000-0.22± 0.06
OG001-0.16± 0.06
OG002-0.20± 0.06
OG003-0.23± 0.06
OG004-0.43± 0.06
OG005-0.47± 0.06
OG006-0.62± 0.06
Change to week 12 (N=112,124,127,122,111,117,120)
Title
Measurements
OG000-0.47± 0.08
OG001-0.43± 0.07
OG002-0.59± 0.07
OG003
Change to week 18 (N=101,121,122,112,104,104,115)
Title
Measurements
OG000-0.63± 0.09
OG001-0.58± 0.08
OG002-0.82± 0.08
OG003
Change to week 24 (N=91,108,110,95,92,96,109)
Title
Measurements
OG000-0.75± 0.09
OG001-0.67± 0.09
OG002-0.87± 0.09
OG003
Change to week 30 (N=78,93,91,79,86,87,97)
Title
Measurements
OG000-0.77± 0.09
OG001-0.73± 0.08
OG002-0.94± 0.09
OG003
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000123
OG001133
OG002134
OG003130
OG004119
OG005123
OG006125
Title
Denominators
Categories
Title
Measurements
OG000-15.16± 3.49
OG001-25.49± 3.28
OG002-28.69± 3.29
OG003-1.46± 3.35
OG004-18.84± 3.47
OG005-27.33± 3.46
OG006-35.19± 3.40
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
0.4275
Mean Difference (Final Values)
-3.68
2-Sided
95
-12.77
5.42
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
0.6839
Mean Difference (Final Values)
-1.84
2-Sided
95
-10.69
7.02
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
0.1466
Mean Difference (Final Values)
-6.50
2-Sided
95
-15.29
2.28
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
0.0002
Mean Difference (Final Values)
-17.38
2-Sided
95
-26.35
-8.41
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
<0.0001
Mean Difference (Final Values)
-25.87
2-Sided
95
-34.77
-16.98
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.
<0.0001
Mean Difference (Final Values)
-33.73
2-Sided
95
-42.57
-24.89
No
Superiority or Other
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003130
OG004120
OG005125
OG006126
Title
Denominators
Categories
Change at week 6 (N=118,132,133,130,119,122,124)
Title
Measurements
OG000-14.43± 2.99
OG001-16.38± 2.80
OG002-15.72± 2.81
OG003-4.25± 2.84
OG004-19.25± 2.96
OG005-26.89± 2.94
OG006-28.36± 2.89
Change at week 12 (N=111,124,126,122,108,114,118)
Title
Measurements
OG000-10.63± 3.24
OG001-21.36± 3.04
OG002-25.30± 3.03
OG003
Change at week 18 (N=100,122,121,111,104,103,114)
Title
Measurements
OG000-16.68± 3.29
OG001-20.69± 3.02
OG002-28.68± 3.03
OG003
Change at week 24 (N=90,108,108,96,93,93,108)
Title
Measurements
OG000-16.25± 3.25
OG001-21.57± 2.99
OG002-27.67± 3.00
OG003
Change at week 30 (N=76,91,89,79,82,87,98)
Title
Measurements
OG000-17.66± 3.35
OG001-26.09± 3.08
OG002-31.76± 3.11
OG003
OG004
Lina5Pio15
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG00029
OG00134
OG00225
OG00322
OG00428
OG00526
OG00631
Title
Denominators
Categories
Title
Measurements
OG000-30.65± 10.93
OG001-83.00± 9.85
OG002-82.98± 10.92
OG003-51.61± 11.67
OG004-67.26± 11.15
OG005-87.94± 11.14
OG006-84.77± 10.28
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.0057
Mean Difference (Final Values)
-36.61
2-Sided
95
-62.42
-10.80
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.7021
Mean Difference (Final Values)
-4.94
95
-30.39
20.51
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.8932
Mean Difference (Final Values)
-1.78
2-Sided
95
-27.95
24.38
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.2706
Mean Difference (Final Values)
-15.65
2-Sided
95
-43.60
12.30
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.0126
Mean Difference (Final Values)
-36.33
2-Sided
95
-64.78
-7.89
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
ANCOVA
The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.
0.0167
Mean Difference (Final Values)
-33.16
2-Sided
95
-60.23
-6.08
No
Superiority or Other
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003130
OG004120
OG005125
OG006126
Title
Denominators
Categories
Proportion event-free
Title
Measurements
OG0000.8117± 50.5
OG0010.8533± 47.8
OG0020.9051± 55.3
OG0030.7756± 47.7
OG0040.8854± 61.5
OG0050.9078± 54.7
OG0060.9548± 65.7
Standard Error
Title
Measurements
OG0000.0382
OG0010.0330
OG0020.0273
OG003
Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
OG005
Lina5Pio30
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
OG006
Lina5Pio45
Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
Units
Counts
Participants
OG000124
OG001134
OG002134
OG003130
OG004120
OG005125
OG006126
Title
Denominators
Categories
Title
Measurements
OG00020
OG00117
OG00211
OG00326
OG00412
OG00510
OG0065
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
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.3052
Odds Ratio (OR)
0.649
95
0.284
1.482
No
Superiority or Other
OG001
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0844
Odds Ratio (OR)
0.456
2-Sided
95
0.187
1.112
No
Superiority or Other
OG002
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.1561
Odds Ratio (OR)
0.443
2-Sided
95
0.143
1.365
No
Superiority or Other
OG003
OG004
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0146
Odds Ratio (OR)
0.368
95
0.165
0.821
No
Superiority or Other
OG003
OG005
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.
0.0009
Odds Ratio (OR)
0.238
95
0.102
0.557
No
Superiority or Other
OG003
OG006
Treatment comparisons are for fixed dose combination versus monotherapy.
Regression, Logistic
A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.