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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
936
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
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 low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
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 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
1264.3.01026 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1264.3.01021 Boehringer Ingelheim Investigational Site
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
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.
Time frame: Baseline and 30 weeks
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.
Time frame: Baseline and 30 weeks
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.
Time frame: 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.
Time frame: 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. by visit interaction.
Time frame: Baseline, week 6, week 12, week 18, week 24, week 30
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.
Time frame: 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
Time frame: Baseline, week 6, week 12, week 18, week 24, week 30
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 frame: Baseline and 30 weeks
Time to First Use of Rescue Therapy
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
Time frame: 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.
Time frame: 30 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 122 more locations