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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Pioglitazone 15 mg; Drug: Linagliptin 5mg / Pioglitazone 15 mg FDC; Drug: Linagliptin 5mg / Pioglitazone 30 mg FDC; Drug: Pioglitazone 45 mg; Drug: Linagliptin 5mg; Drug: Linagliptin 5mg / Pioglitazone 45 mg FDC; Drug: Pioglitazone 30 mg

• Registration Number: NCT01183013
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2014-03-12
• Results First Submitted QC: 2014-03-14
• Results First Posted: 2014-04-21
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 936

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone 15 mg	Pioglitazone 15 mg	Pioglitazone Capsules 15 mg once daily
Linagliptin 5mg / Pioglitazone 15 mg	Linagliptin 5mg / Pioglitazone 15 mg FDC	Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
Linagliptin 5mg / Pioglitazone 30 mg	Linagliptin 5mg / Pioglitazone 30 mg FDC	Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
Pioglitazone 45 mg	Pioglitazone 45 mg	Pioglitazone Capsules 45 mg once daily
Linagliptin 5mg	Linagliptin 5mg	Linagliptin 5mg Tablets once daily
Linagliptin 5mg / Pioglitazone 45 mg	Linagliptin 5mg / Pioglitazone 45 mg FDC	Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
Pioglitazone 30 mg	Pioglitazone 30 mg	Pioglitazone Capsules 30 mg once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 30 Weeks of Treatment.	Baseline and 30 weeks	HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time	Baseline, week 6, week 12, week 18, week 24, week 30	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 to First Use of Rescue Therapy	30 weeks	Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
Incidence of Rescue Therapy During the First 30 Weeks of Treatment	30 weeks	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.
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment	Baseline and 30 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)	Baseline and 30 weeks	The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment	Baseline and 30 weeks	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)	Baseline and 30 weeks	Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
HbA1c Change From Baseline by Visit Over Time	Baseline, week 6, week 12, week 18, week 24, week 30	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	Baseline and 30 weeks	The change from baseline is the FPG after 30 weeks minus the baseline FPG.

Trial Locations

Locations (132)

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

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

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