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

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Exclusion Criteria

Not provided

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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)

1264.3.01006 Boehringer Ingelheim Investigational Site; 🇺🇸 Norwalk, California, United States

1264.3.01044 Boehringer Ingelheim Investigational Site; 🇺🇸 Charlotte, North Carolina, United States

1264.3.01084 Boehringer Ingelheim Investigational Site; 🇺🇸 Cartersville, Georgia, United States

1264.3.01069 Boehringer Ingelheim Investigational Site; 🇺🇸 Hyattsville, Maryland, United States

1264.3.37209 Boehringer Ingelheim Investigational Site; 🇪🇪 Pärnu, Estonia

1264.3.01045 Boehringer Ingelheim Investigational Site; 🇺🇸 Burlington, North Carolina, United States

1264.3.49012 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany

1264.3.49008 Boehringer Ingelheim Investigational Site; 🇩🇪 Leipzig, Germany

1264.3.49010 Boehringer Ingelheim Investigational Site; 🇩🇪 Offenbach, Germany

1264.3.01056 Boehringer Ingelheim Investigational Site; 🇺🇸 Norfolk, Virginia, United States

1264.3.34001 Boehringer Ingelheim Investigational Site; 🇪🇸 Barcelona, Spain

1264.3.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Stuhr, Germany

1264.3.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Dortmund, Germany

1264.3.44029 Boehringer Ingelheim Investigational Site; 🇬🇧 Baillieston, Glasgow, United Kingdom

1264.3.34005 Boehringer Ingelheim Investigational Site; 🇪🇸 Borges del Camp- Tarragona, Spain

1264.3.34010 Boehringer Ingelheim Investigational Site; 🇪🇸 Centelles - Barcelona, Spain

1264.3.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 Dietzenbach, Germany

1264.3.44028 Boehringer Ingelheim Investigational Site; 🇬🇧 Ash Vale, Aldershot, United Kingdom

1264.3.34009 Boehringer Ingelheim Investigational Site; 🇪🇸 L'Hospitalet de Llobregat, Spain

1264.3.34007 Boehringer Ingelheim Investigational Site; 🇪🇸 Tarrega - Lleida, Spain

1264.3.44011 Boehringer Ingelheim Investigational Site; 🇬🇧 Chippenham, United Kingdom

1264.3.34008 Boehringer Ingelheim Investigational Site; 🇪🇸 Barcelona, Spain

1264.3.34006 Boehringer Ingelheim Investigational Site; 🇪🇸 Canet de Mar - Barcelona, Spain

1264.3.44032 Boehringer Ingelheim Investigational Site; 🇬🇧 Annan, United Kingdom

1264.3.34013 Boehringer Ingelheim Investigational Site; 🇪🇸 Badía del Vallès - Barcelona, 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

1264.3.44027 Boehringer Ingelheim Investigational Site; 🇬🇧 Chestfield, Whitstable, United Kingdom

1264.3.44034 Boehringer Ingelheim Investigational Site; 🇬🇧 Paisley, United Kingdom

1264.3.01031 Boehringer Ingelheim Investigational Site; 🇺🇸 Concord, California, United States

1264.3.01050 Boehringer Ingelheim Investigational Site; 🇺🇸 Savannah, Georgia, United States

1264.3.01049 Boehringer Ingelheim Investigational Site; 🇺🇸 Carmichael, California, United States

1264.3.01017 Boehringer Ingelheim Investigational Site; 🇺🇸 Corpus Christi, Texas, United States

1264.3.01004 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1264.3.01079 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1264.3.01061 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

1264.3.01066 Boehringer Ingelheim Investigational Site; 🇺🇸 Southfield, Michigan, United States

1264.3.01039 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1264.3.01047 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1264.3.01064 Boehringer Ingelheim Investigational Site; 🇺🇸 Mesa, Arizona, United States

1264.3.01033 Boehringer Ingelheim Investigational Site; 🇺🇸 Norwalk, Connecticut, United States

1264.3.01065 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States

1264.3.01074 Boehringer Ingelheim Investigational Site; 🇺🇸 Blue Ridge, Georgia, United States

1264.3.01041 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1264.3.01082 Boehringer Ingelheim Investigational Site; 🇺🇸 Hialeah, Florida, United States

1264.3.01042 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1264.3.01077 Boehringer Ingelheim Investigational Site; 🇺🇸 Chicago, Illinois, United States

1264.3.01057 Boehringer Ingelheim Investigational Site; 🇺🇸 Great Falls, Montana, United States

1264.3.01081 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbia, South Carolina, United States

1264.3.01070 Boehringer Ingelheim Investigational Site; 🇺🇸 Houston, Texas, United States

1264.3.01025 Boehringer Ingelheim Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

1264.3.01067 Boehringer Ingelheim Investigational Site; 🇺🇸 Dallas, Texas, United States

1264.3.01007 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

1264.3.01002 Boehringer Ingelheim Investigational Site; 🇺🇸 Wichita, Kansas, United States

1264.3.44033 Boehringer Ingelheim Investigational Site; 🇬🇧 Johnstone, United Kingdom

1264.3.01012 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1264.3.01032 Boehringer Ingelheim Investigational Site; 🇺🇸 Oklahoma City, Oklahoma, United States

1264.3.01026 Boehringer Ingelheim Investigational Site; 🇺🇸 Birmingham, Alabama, United States

1264.3.01059 Boehringer Ingelheim Investigational Site; 🇺🇸 San Diego, California, United States

1264.3.01009 Boehringer Ingelheim Investigational Site; 🇺🇸 Tampa, Florida, United States

1264.3.49001 Boehringer Ingelheim Investigational Site; 🇩🇪 Bad Lauterberg / Harz, Germany

1264.3.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Hamburg, Germany

1264.3.34012 Boehringer Ingelheim Investigational Site; 🇪🇸 Valencia, Spain

1264.3.34011 Boehringer Ingelheim Investigational Site; 🇪🇸 Vic - Barcelona, Spain

1264.3.01021 Boehringer Ingelheim Investigational Site; 🇺🇸 Montgomery, Alabama, United States

1264.3.01020 Boehringer Ingelheim Investigational Site; 🇺🇸 Muscle Shoals, Alabama, United States

1264.3.01078 Boehringer Ingelheim Investigational Site; 🇺🇸 Chino, California, United States

1264.3.01037 Boehringer Ingelheim Investigational Site; 🇺🇸 Lakewood, California, United States

1264.3.01058 Boehringer Ingelheim Investigational Site; 🇺🇸 Valencia, California, United States

1264.3.01027 Boehringer Ingelheim Investigational Site; 🇺🇸 Denver, Colorado, United States

1264.3.01035 Boehringer Ingelheim Investigational Site; 🇺🇸 Boca Raton, Florida, United States

1264.3.01038 Boehringer Ingelheim Investigational Site; 🇺🇸 Miami, Florida, United States

1264.3.01052 Boehringer Ingelheim Investigational Site; 🇺🇸 Brownsburg, Indiana, United States

1264.3.01076 Boehringer Ingelheim Investigational Site; 🇺🇸 Evansville, Indiana, United States

1264.3.01029 Boehringer Ingelheim Investigational Site; 🇺🇸 Sunset, Louisiana, United States

1264.3.01022 Boehringer Ingelheim Investigational Site; 🇺🇸 Zanesville, Ohio, United States

1264.3.01011 Boehringer Ingelheim Investigational Site; 🇺🇸 Kingsport, Tennessee, United States

1264.3.01048 Boehringer Ingelheim Investigational Site; 🇺🇸 Midland, 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

1264.3.37210 Boehringer Ingelheim Investigational Site; 🇪🇪 Viljandi County, Estonia

1264.3.49009 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

1264.3.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Mainz, Germany

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

1264.3.44007 Boehringer Ingelheim Investigational Site; 🇬🇧 Midsomer Norton, United Kingdom

1264.3.44031 Boehringer Ingelheim Investigational Site; 🇬🇧 Warminster, United Kingdom

1264.3.01023 Boehringer Ingelheim Investigational Site; 🇺🇸 Tarzana, California, United States

1264.3.01016 Boehringer Ingelheim Investigational Site; 🇺🇸 Tustin, California, United States

1264.3.01015 Boehringer Ingelheim Investigational Site; 🇺🇸 Clearwater, Florida, United States

1264.3.01083 Boehringer Ingelheim Investigational Site; 🇺🇸 Westlake Village, California, United States

1264.3.01036 Boehringer Ingelheim Investigational Site; 🇺🇸 Jacksonville, Florida, United States

1264.3.01013 Boehringer Ingelheim Investigational Site; 🇺🇸 Longwood, Florida, United States

1264.3.01019 Boehringer Ingelheim Investigational Site; 🇺🇸 Port Orange, Florida, United States

1264.3.01018 Boehringer Ingelheim Investigational Site; 🇺🇸 St. Cloud, Florida, United States

1264.3.01008 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

1264.3.01051 Boehringer Ingelheim Investigational Site; 🇺🇸 Fleetwood, Pennsylvania, United States

1264.3.01055 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

1264.3.01060 Boehringer Ingelheim Investigational Site; 🇺🇸 Perry, Georgia, United States

1264.3.01075 Boehringer Ingelheim Investigational Site; 🇺🇸 Evansville, Indiana, United States

1264.3.01073 Boehringer Ingelheim Investigational Site; 🇺🇸 Franklin, Indiana, United States

1264.3.01040 Boehringer Ingelheim Investigational Site; 🇺🇸 Killeen, Texas, United States

1264.3.01030 Boehringer Ingelheim Investigational Site; 🇺🇸 New Braunfels, Texas, United States

1264.3.01001 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Cucamonga, California, United States

1264.3.01071 Boehringer Ingelheim Investigational Site; 🇺🇸 North Richland Hills, Texas, United States

1264.3.37204 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallin, Estonia

1264.3.37206 Boehringer Ingelheim Investigational Site; 🇪🇪 Tartu, Estonia

1264.3.37112 Boehringer Ingelheim Investigational Site; 🇱🇻 Daugavpils, Latvia

1264.3.37113 Boehringer Ingelheim Investigational Site; 🇱🇻 Daugavpils, Latvia

1264.3.01062 Boehringer Ingelheim Investigational Site; 🇺🇸 Chandler, Arizona, United States

1264.3.01003 Boehringer Ingelheim Investigational Site; 🇺🇸 Greer, South Carolina, United States

1264.3.37201 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallinn, Estonia

1264.3.37208 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallinn, Estonia

1264.3.37207 Boehringer Ingelheim Investigational Site; 🇪🇪 Harju, Estonia

1264.3.37202 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallinn, Estonia

1264.3.37203 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallin, Estonia

1264.3.37205 Boehringer Ingelheim Investigational Site; 🇪🇪 Tallin, Estonia

1264.3.37105 Boehringer Ingelheim Investigational Site; 🇱🇻 Daugavpils, Latvia

1264.3.37110 Boehringer Ingelheim Investigational Site; 🇱🇻 Jelgava, Latvia

1264.3.37101 Boehringer Ingelheim Investigational Site; 🇱🇻 Liepaja, 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

1264.3.01010 Boehringer Ingelheim Investigational Site; 🇺🇸 Lexington, Kentucky, United States

1264.3.01028 Boehringer Ingelheim Investigational Site; 🇺🇸 New Orleans, Louisiana, United States