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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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. 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)
  3. Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
  4. BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria:

  1. 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)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. 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)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

  7. 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
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. 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

  15. 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

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

Sites / Locations

  • 1264.3.01026 Boehringer Ingelheim Investigational Site
  • 1264.3.01021 Boehringer Ingelheim Investigational Site
  • 1264.3.01020 Boehringer Ingelheim Investigational Site
  • 1264.3.01062 Boehringer Ingelheim Investigational Site
  • 1264.3.01064 Boehringer Ingelheim Investigational Site
  • 1264.3.01049 Boehringer Ingelheim Investigational Site
  • 1264.3.01078 Boehringer Ingelheim Investigational Site
  • 1264.3.01031 Boehringer Ingelheim Investigational Site
  • 1264.3.01037 Boehringer Ingelheim Investigational Site
  • 1264.3.01065 Boehringer Ingelheim Investigational Site
  • 1264.3.01006 Boehringer Ingelheim Investigational Site
  • 1264.3.01001 Boehringer Ingelheim Investigational Site
  • 1264.3.01059 Boehringer Ingelheim Investigational Site
  • 1264.3.01023 Boehringer Ingelheim Investigational Site
  • 1264.3.01016 Boehringer Ingelheim Investigational Site
  • 1264.3.01058 Boehringer Ingelheim Investigational Site
  • 1264.3.01083 Boehringer Ingelheim Investigational Site
  • 1264.3.01027 Boehringer Ingelheim Investigational Site
  • 1264.3.01033 Boehringer Ingelheim Investigational Site
  • 1264.3.01035 Boehringer Ingelheim Investigational Site
  • 1264.3.01015 Boehringer Ingelheim Investigational Site
  • 1264.3.01082 Boehringer Ingelheim Investigational Site
  • 1264.3.01036 Boehringer Ingelheim Investigational Site
  • 1264.3.01013 Boehringer Ingelheim Investigational Site
  • 1264.3.01038 Boehringer Ingelheim Investigational Site
  • 1264.3.01042 Boehringer Ingelheim Investigational Site
  • 1264.3.01079 Boehringer Ingelheim Investigational Site
  • 1264.3.01019 Boehringer Ingelheim Investigational Site
  • 1264.3.01018 Boehringer Ingelheim Investigational Site
  • 1264.3.01009 Boehringer Ingelheim Investigational Site
  • 1264.3.01012 Boehringer Ingelheim Investigational Site
  • 1264.3.01008 Boehringer Ingelheim Investigational Site
  • 1264.3.01055 Boehringer Ingelheim Investigational Site
  • 1264.3.01061 Boehringer Ingelheim Investigational Site
  • 1264.3.01074 Boehringer Ingelheim Investigational Site
  • 1264.3.01084 Boehringer Ingelheim Investigational Site
  • 1264.3.01060 Boehringer Ingelheim Investigational Site
  • 1264.3.01050 Boehringer Ingelheim Investigational Site
  • 1264.3.01077 Boehringer Ingelheim Investigational Site
  • 1264.3.01052 Boehringer Ingelheim Investigational Site
  • 1264.3.01075 Boehringer Ingelheim Investigational Site
  • 1264.3.01076 Boehringer Ingelheim Investigational Site
  • 1264.3.01073 Boehringer Ingelheim Investigational Site
  • 1264.3.01002 Boehringer Ingelheim Investigational Site
  • 1264.3.01007 Boehringer Ingelheim Investigational Site
  • 1264.3.01010 Boehringer Ingelheim Investigational Site
  • 1264.3.01028 Boehringer Ingelheim Investigational Site
  • 1264.3.01029 Boehringer Ingelheim Investigational Site
  • 1264.3.01069 Boehringer Ingelheim Investigational Site
  • 1264.3.01066 Boehringer Ingelheim Investigational Site
  • 1264.3.01057 Boehringer Ingelheim Investigational Site
  • 1264.3.01045 Boehringer Ingelheim Investigational Site
  • 1264.3.01044 Boehringer Ingelheim Investigational Site
  • 1264.3.01022 Boehringer Ingelheim Investigational Site
  • 1264.3.01032 Boehringer Ingelheim Investigational Site
  • 1264.3.01051 Boehringer Ingelheim Investigational Site
  • 1264.3.01025 Boehringer Ingelheim Investigational Site
  • 1264.3.01081 Boehringer Ingelheim Investigational Site
  • 1264.3.01003 Boehringer Ingelheim Investigational Site
  • 1264.3.01011 Boehringer Ingelheim Investigational Site
  • 1264.3.01017 Boehringer Ingelheim Investigational Site
  • 1264.3.01067 Boehringer Ingelheim Investigational Site
  • 1264.3.01004 Boehringer Ingelheim Investigational Site
  • 1264.3.01039 Boehringer Ingelheim Investigational Site
  • 1264.3.01041 Boehringer Ingelheim Investigational Site
  • 1264.3.01047 Boehringer Ingelheim Investigational Site
  • 1264.3.01070 Boehringer Ingelheim Investigational Site
  • 1264.3.01040 Boehringer Ingelheim Investigational Site
  • 1264.3.01048 Boehringer Ingelheim Investigational Site
  • 1264.3.01030 Boehringer Ingelheim Investigational Site
  • 1264.3.01071 Boehringer Ingelheim Investigational Site
  • 1264.3.01085 Boehringer Ingelheim Investigational Site
  • 1264.3.01046 Boehringer Ingelheim Investigational Site
  • 1264.3.01056 Boehringer Ingelheim Investigational Site
  • 1264.3.37207 Boehringer Ingelheim Investigational Site
  • 1264.3.37209 Boehringer Ingelheim Investigational Site
  • 1264.3.37201 Boehringer Ingelheim Investigational Site
  • 1264.3.37202 Boehringer Ingelheim Investigational Site
  • 1264.3.37208 Boehringer Ingelheim Investigational Site
  • 1264.3.37203 Boehringer Ingelheim Investigational Site
  • 1264.3.37204 Boehringer Ingelheim Investigational Site
  • 1264.3.37205 Boehringer Ingelheim Investigational Site
  • 1264.3.37206 Boehringer Ingelheim Investigational Site
  • 1264.3.37210 Boehringer Ingelheim Investigational Site
  • 1264.3.49001 Boehringer Ingelheim Investigational Site
  • 1264.3.49007 Boehringer Ingelheim Investigational Site
  • 1264.3.49002 Boehringer Ingelheim Investigational Site
  • 1264.3.49009 Boehringer Ingelheim Investigational Site
  • 1264.3.49003 Boehringer Ingelheim Investigational Site
  • 1264.3.49012 Boehringer Ingelheim Investigational Site
  • 1264.3.49008 Boehringer Ingelheim Investigational Site
  • 1264.3.49005 Boehringer Ingelheim Investigational Site
  • 1264.3.49010 Boehringer Ingelheim Investigational Site
  • 1264.3.49004 Boehringer Ingelheim Investigational Site
  • 1264.3.37105 Boehringer Ingelheim Investigational Site
  • 1264.3.37112 Boehringer Ingelheim Investigational Site
  • 1264.3.37113 Boehringer Ingelheim Investigational Site
  • 1264.3.37110 Boehringer Ingelheim Investigational Site
  • 1264.3.37101 Boehringer Ingelheim Investigational Site
  • 1264.3.37106 Boehringer Ingelheim Investigational Site
  • 1264.3.37104 Boehringer Ingelheim Investigational Site
  • 1264.3.37108 Boehringer Ingelheim Investigational Site
  • 1264.3.37109 Boehringer Ingelheim Investigational Site
  • 1264.3.37111 Boehringer Ingelheim Investigational Site
  • 1264.3.37107 Boehringer Ingelheim Investigational Site
  • 1264.3.37102 Boehringer Ingelheim Investigational Site
  • 1264.3.37103 Boehringer Ingelheim Investigational Site
  • 1264.3.34013 Boehringer Ingelheim Investigational Site
  • 1264.3.34001 Boehringer Ingelheim Investigational Site
  • 1264.3.34008 Boehringer Ingelheim Investigational Site
  • 1264.3.34005 Boehringer Ingelheim Investigational Site
  • 1264.3.34006 Boehringer Ingelheim Investigational Site
  • 1264.3.34010 Boehringer Ingelheim Investigational Site
  • 1264.3.34004 Boehringer Ingelheim Investigational Site
  • 1264.3.34009 Boehringer Ingelheim Investigational Site
  • 1264.3.34002 Boehringer Ingelheim Investigational Site
  • 1264.3.34007 Boehringer Ingelheim Investigational Site
  • 1264.3.34012 Boehringer Ingelheim Investigational Site
  • 1264.3.34011 Boehringer Ingelheim Investigational Site
  • 1264.3.44032 Boehringer Ingelheim Investigational Site
  • 1264.3.44028 Boehringer Ingelheim Investigational Site
  • 1264.3.44029 Boehringer Ingelheim Investigational Site
  • 1264.3.44008 Boehringer Ingelheim Investigational Site
  • 1264.3.44021 Boehringer Ingelheim Investigational Site
  • 1264.3.44019 Boehringer Ingelheim Investigational Site
  • 1264.3.44012 Boehringer Ingelheim Investigational Site
  • 1264.3.44027 Boehringer Ingelheim Investigational Site
  • 1264.3.44011 Boehringer Ingelheim Investigational Site
  • 1264.3.44033 Boehringer Ingelheim Investigational Site
  • 1264.3.44007 Boehringer Ingelheim Investigational Site
  • 1264.3.44034 Boehringer Ingelheim Investigational Site
  • 1264.3.44031 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Pioglitazone 15 mg

Pioglitazone 30 mg

Pioglitazone 45 mg

Linagliptin 5mg

Linagliptin 5mg / Pioglitazone 15 mg

Linagliptin 5mg / Pioglitazone 30 mg

Linagliptin 5mg / Pioglitazone 45 mg

Arm Description

Pioglitazone Capsules 15 mg once daily

Pioglitazone Capsules 30 mg once daily

Pioglitazone Capsules 45 mg once daily

Linagliptin 5mg Tablets once daily

Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily

Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily

Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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. by visit interaction.
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.
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.
Time to First Use of Rescue Therapy
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
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.

Full Information

First Posted
August 16, 2010
Last Updated
October 9, 2014
Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01183013
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
936 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone 15 mg
Arm Type
Active Comparator
Arm Description
Pioglitazone Capsules 15 mg once daily
Arm Title
Pioglitazone 30 mg
Arm Type
Active Comparator
Arm Description
Pioglitazone Capsules 30 mg once daily
Arm Title
Pioglitazone 45 mg
Arm Type
Active Comparator
Arm Description
Pioglitazone Capsules 45 mg once daily
Arm Title
Linagliptin 5mg
Arm Type
Active Comparator
Arm Description
Linagliptin 5mg Tablets once daily
Arm Title
Linagliptin 5mg / Pioglitazone 15 mg
Arm Type
Experimental
Arm Description
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Arm Title
Linagliptin 5mg / Pioglitazone 30 mg
Arm Type
Experimental
Arm Description
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Arm Title
Linagliptin 5mg / Pioglitazone 45 mg
Arm Type
Experimental
Arm Description
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 15 mg
Intervention Description
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 45 mg
Intervention Description
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Intervention Type
Drug
Intervention Name(s)
Pioglitazone 30 mg
Intervention Description
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
Intervention Type
Drug
Intervention Name(s)
Linagliptin 5mg / Pioglitazone 45 mg FDC
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Linagliptin 5mg / Pioglitazone 30 mg FDC
Intervention Description
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
Intervention Type
Drug
Intervention Name(s)
Linagliptin 5mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Linagliptin 5mg / Pioglitazone 15 mg FDC
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c After 30 Weeks of Treatment.
Description
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Time Frame
Baseline and 30 weeks
Secondary Outcome Measure Information:
Title
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
Description
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Time Frame
Baseline and 30 weeks
Title
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
Description
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Time Frame
Baseline and 30 weeks
Title
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
Description
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Time Frame
Baseline and 30 weeks
Title
HbA1c Change From Baseline by Visit Over Time
Description
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. by visit interaction.
Time Frame
Baseline, week 6, week 12, week 18, week 24, week 30
Title
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
Description
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Time Frame
Baseline and 30 weeks
Title
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
Description
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
Time Frame
Baseline, week 6, week 12, week 18, week 24, week 30
Title
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
Description
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Time Frame
Baseline and 30 weeks
Title
Time to First Use of Rescue Therapy
Description
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
Time Frame
30 weeks
Title
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
Description
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.
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1264.3.01026 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1264.3.01021 Boehringer Ingelheim Investigational Site
City
Montgomery
State/Province
Alabama
Country
United States
Facility Name
1264.3.01020 Boehringer Ingelheim Investigational Site
City
Muscle Shoals
State/Province
Alabama
Country
United States
Facility Name
1264.3.01062 Boehringer Ingelheim Investigational Site
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
1264.3.01064 Boehringer Ingelheim Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
1264.3.01049 Boehringer Ingelheim Investigational Site
City
Carmichael
State/Province
California
Country
United States
Facility Name
1264.3.01078 Boehringer Ingelheim Investigational Site
City
Chino
State/Province
California
Country
United States
Facility Name
1264.3.01031 Boehringer Ingelheim Investigational Site
City
Concord
State/Province
California
Country
United States
Facility Name
1264.3.01037 Boehringer Ingelheim Investigational Site
City
Lakewood
State/Province
California
Country
United States
Facility Name
1264.3.01065 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1264.3.01006 Boehringer Ingelheim Investigational Site
City
Norwalk
State/Province
California
Country
United States
Facility Name
1264.3.01001 Boehringer Ingelheim Investigational Site
City
Rancho Cucamonga
State/Province
California
Country
United States
Facility Name
1264.3.01059 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1264.3.01023 Boehringer Ingelheim Investigational Site
City
Tarzana
State/Province
California
Country
United States
Facility Name
1264.3.01016 Boehringer Ingelheim Investigational Site
City
Tustin
State/Province
California
Country
United States
Facility Name
1264.3.01058 Boehringer Ingelheim Investigational Site
City
Valencia
State/Province
California
Country
United States
Facility Name
1264.3.01083 Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
1264.3.01027 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1264.3.01033 Boehringer Ingelheim Investigational Site
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
1264.3.01035 Boehringer Ingelheim Investigational Site
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
1264.3.01015 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1264.3.01082 Boehringer Ingelheim Investigational Site
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
1264.3.01036 Boehringer Ingelheim Investigational Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
1264.3.01013 Boehringer Ingelheim Investigational Site
City
Longwood
State/Province
Florida
Country
United States
Facility Name
1264.3.01038 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1264.3.01042 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1264.3.01079 Boehringer Ingelheim Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
1264.3.01019 Boehringer Ingelheim Investigational Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
1264.3.01018 Boehringer Ingelheim Investigational Site
City
St. Cloud
State/Province
Florida
Country
United States
Facility Name
1264.3.01009 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1264.3.01012 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1264.3.01008 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1264.3.01055 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1264.3.01061 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1264.3.01074 Boehringer Ingelheim Investigational Site
City
Blue Ridge
State/Province
Georgia
Country
United States
Facility Name
1264.3.01084 Boehringer Ingelheim Investigational Site
City
Cartersville
State/Province
Georgia
Country
United States
Facility Name
1264.3.01060 Boehringer Ingelheim Investigational Site
City
Perry
State/Province
Georgia
Country
United States
Facility Name
1264.3.01050 Boehringer Ingelheim Investigational Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
1264.3.01077 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1264.3.01052 Boehringer Ingelheim Investigational Site
City
Brownsburg
State/Province
Indiana
Country
United States
Facility Name
1264.3.01075 Boehringer Ingelheim Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
1264.3.01076 Boehringer Ingelheim Investigational Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
1264.3.01073 Boehringer Ingelheim Investigational Site
City
Franklin
State/Province
Indiana
Country
United States
Facility Name
1264.3.01002 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1264.3.01007 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1264.3.01010 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
1264.3.01028 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1264.3.01029 Boehringer Ingelheim Investigational Site
City
Sunset
State/Province
Louisiana
Country
United States
Facility Name
1264.3.01069 Boehringer Ingelheim Investigational Site
City
Hyattsville
State/Province
Maryland
Country
United States
Facility Name
1264.3.01066 Boehringer Ingelheim Investigational Site
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
1264.3.01057 Boehringer Ingelheim Investigational Site
City
Great Falls
State/Province
Montana
Country
United States
Facility Name
1264.3.01045 Boehringer Ingelheim Investigational Site
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
1264.3.01044 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
1264.3.01022 Boehringer Ingelheim Investigational Site
City
Zanesville
State/Province
Ohio
Country
United States
Facility Name
1264.3.01032 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1264.3.01051 Boehringer Ingelheim Investigational Site
City
Fleetwood
State/Province
Pennsylvania
Country
United States
Facility Name
1264.3.01025 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1264.3.01081 Boehringer Ingelheim Investigational Site
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
1264.3.01003 Boehringer Ingelheim Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
1264.3.01011 Boehringer Ingelheim Investigational Site
City
Kingsport
State/Province
Tennessee
Country
United States
Facility Name
1264.3.01017 Boehringer Ingelheim Investigational Site
City
Corpus Christi
State/Province
Texas
Country
United States
Facility Name
1264.3.01067 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1264.3.01004 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1264.3.01039 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1264.3.01041 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1264.3.01047 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1264.3.01070 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1264.3.01040 Boehringer Ingelheim Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
1264.3.01048 Boehringer Ingelheim Investigational Site
City
Midland
State/Province
Texas
Country
United States
Facility Name
1264.3.01030 Boehringer Ingelheim Investigational Site
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
1264.3.01071 Boehringer Ingelheim Investigational Site
City
North Richland Hills
State/Province
Texas
Country
United States
Facility Name
1264.3.01085 Boehringer Ingelheim Investigational Site
City
Plano
State/Province
Texas
Country
United States
Facility Name
1264.3.01046 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1264.3.01056 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
1264.3.37207 Boehringer Ingelheim Investigational Site
City
Harju
Country
Estonia
Facility Name
1264.3.37209 Boehringer Ingelheim Investigational Site
City
Pärnu
Country
Estonia
Facility Name
1264.3.37201 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1264.3.37202 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1264.3.37208 Boehringer Ingelheim Investigational Site
City
Tallinn
Country
Estonia
Facility Name
1264.3.37203 Boehringer Ingelheim Investigational Site
City
Tallin
Country
Estonia
Facility Name
1264.3.37204 Boehringer Ingelheim Investigational Site
City
Tallin
Country
Estonia
Facility Name
1264.3.37205 Boehringer Ingelheim Investigational Site
City
Tallin
Country
Estonia
Facility Name
1264.3.37206 Boehringer Ingelheim Investigational Site
City
Tartu
Country
Estonia
Facility Name
1264.3.37210 Boehringer Ingelheim Investigational Site
City
Viljandi County
Country
Estonia
Facility Name
1264.3.49001 Boehringer Ingelheim Investigational Site
City
Bad Lauterberg / Harz
Country
Germany
Facility Name
1264.3.49007 Boehringer Ingelheim Investigational Site
City
Dietzenbach
Country
Germany
Facility Name
1264.3.49002 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1264.3.49009 Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
1264.3.49003 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1264.3.49012 Boehringer Ingelheim Investigational Site
City
Ingelheim
Country
Germany
Facility Name
1264.3.49008 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1264.3.49005 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1264.3.49010 Boehringer Ingelheim Investigational Site
City
Offenbach
Country
Germany
Facility Name
1264.3.49004 Boehringer Ingelheim Investigational Site
City
Stuhr
Country
Germany
Facility Name
1264.3.37105 Boehringer Ingelheim Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
1264.3.37112 Boehringer Ingelheim Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
1264.3.37113 Boehringer Ingelheim Investigational Site
City
Daugavpils
Country
Latvia
Facility Name
1264.3.37110 Boehringer Ingelheim Investigational Site
City
Jelgava
Country
Latvia
Facility Name
1264.3.37101 Boehringer Ingelheim Investigational Site
City
Liepaja
Country
Latvia
Facility Name
1264.3.37106 Boehringer Ingelheim Investigational Site
City
Ogre
Country
Latvia
Facility Name
1264.3.37104 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1264.3.37108 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1264.3.37109 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1264.3.37111 Boehringer Ingelheim Investigational Site
City
Riga
Country
Latvia
Facility Name
1264.3.37107 Boehringer Ingelheim Investigational Site
City
Talsi
Country
Latvia
Facility Name
1264.3.37102 Boehringer Ingelheim Investigational Site
City
Tukums
Country
Latvia
Facility Name
1264.3.37103 Boehringer Ingelheim Investigational Site
City
Valmiera
Country
Latvia
Facility Name
1264.3.34013 Boehringer Ingelheim Investigational Site
City
Badía del Vallès - Barcelona
Country
Spain
Facility Name
1264.3.34001 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1264.3.34008 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1264.3.34005 Boehringer Ingelheim Investigational Site
City
Borges del Camp- Tarragona
Country
Spain
Facility Name
1264.3.34006 Boehringer Ingelheim Investigational Site
City
Canet de Mar - Barcelona
Country
Spain
Facility Name
1264.3.34010 Boehringer Ingelheim Investigational Site
City
Centelles - Barcelona
Country
Spain
Facility Name
1264.3.34004 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat - Barcelona
Country
Spain
Facility Name
1264.3.34009 Boehringer Ingelheim Investigational Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
1264.3.34002 Boehringer Ingelheim Investigational Site
City
Sant Adrià del Besós- Barcelona
Country
Spain
Facility Name
1264.3.34007 Boehringer Ingelheim Investigational Site
City
Tarrega - Lleida
Country
Spain
Facility Name
1264.3.34012 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1264.3.34011 Boehringer Ingelheim Investigational Site
City
Vic - Barcelona
Country
Spain
Facility Name
1264.3.44032 Boehringer Ingelheim Investigational Site
City
Annan
Country
United Kingdom
Facility Name
1264.3.44028 Boehringer Ingelheim Investigational Site
City
Ash Vale, Aldershot
Country
United Kingdom
Facility Name
1264.3.44029 Boehringer Ingelheim Investigational Site
City
Baillieston, Glasgow
Country
United Kingdom
Facility Name
1264.3.44008 Boehringer Ingelheim Investigational Site
City
Balham
Country
United Kingdom
Facility Name
1264.3.44021 Boehringer Ingelheim Investigational Site
City
Bradford on Avon
Country
United Kingdom
Facility Name
1264.3.44019 Boehringer Ingelheim Investigational Site
City
Burbage
Country
United Kingdom
Facility Name
1264.3.44012 Boehringer Ingelheim Investigational Site
City
Chesterfield
Country
United Kingdom
Facility Name
1264.3.44027 Boehringer Ingelheim Investigational Site
City
Chestfield, Whitstable
Country
United Kingdom
Facility Name
1264.3.44011 Boehringer Ingelheim Investigational Site
City
Chippenham
Country
United Kingdom
Facility Name
1264.3.44033 Boehringer Ingelheim Investigational Site
City
Johnstone
Country
United Kingdom
Facility Name
1264.3.44007 Boehringer Ingelheim Investigational Site
City
Midsomer Norton
Country
United Kingdom
Facility Name
1264.3.44034 Boehringer Ingelheim Investigational Site
City
Paisley
Country
United Kingdom
Facility Name
1264.3.44031 Boehringer Ingelheim Investigational Site
City
Warminster
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1264/1264.3_C01655906-01.pdf
Description
Related Info

Learn more about this trial

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

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