Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Bi 1356 + metformin
Drug: matching placebo
Drug: metformin
Drug: BI 1356

Registration Number: NCT00798161

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 857

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1356 + metformin	Bi 1356 + metformin	BI 1356 low dose + metformin 500 mg, twice daily
matching placebo	matching placebo	matching placebo
BI 1356+ Metformin	Bi 1356 + metformin	BI 1356 low dose + metformin 1000 mg, twice daily
Metformin	metformin	Metformin 500 mg, twice daily
BI 1356	BI 1356	BI 1356 high dose, once daily
metformin	metformin	Metformin 1000 mg, twice daily

Primary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 24	Baseline and week 24	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

Secondary Outcome Measures

Name	Time	Method
HbA1c Change From Baseline at Week 6	Baseline and week 6	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 6 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 12	Baseline and week 12	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
HbA1c Change From Baseline at Week 18	Baseline and week 18	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
FPG Change From Baseline at Week 24	Baseline and week 24	This change from baseline reflects the Week 24 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 2	Baseline and week 2	This change from baseline reflects the Week 2 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 6	Baseline and week 6	This change from baseline reflects the Week 6 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 12	Baseline and week 12	This change from baseline reflects the Week 12 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
FPG Change From Baseline at Week 18	Baseline and week 18	This change from baseline reflects the Week 18 FPG minus the baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c <7.0% at Week 24	Baseline and Week 24	The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c<7.0 at Week 24	Baseline and Week 24	The percentage of patients with an HbA1c value below 7% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 7%.
Percentage of Patients With HbA1c <6.5% at Week 24	Baseline and Week 24	The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%. Only patients with baseline HbA1c =\< 6.5%
Adjusted Means for 2h Post-Prandial Glucose (PPG) Change From Baseline at Week 24	Baseline and week 24	This change from baseline reflects the Week 24 2h PPG minus the baseline 2h PPG. Means are treatment adjusted for baseline HbA1c, baseline 2h PPG and previous anti-diabetic medication.
Percentage of Patients With HbA1c < 6.5% at Week 24	Baseline and Week 24	The percentage of patients with an HbA1c value below 6.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c above 6.5%
HbA1c Change From Baseline at Week 24 for Open-label Patients	Baseline and week 24	HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percentage. Mean is unadjusted.
FPG Change From Baseline at Week 24 for Open-label Patients	Baseline and week 24	This change from baseline reflects the Week 24 FPG minus the baseline FPG. Mean is unadjusted.
Use of Rescue Therapy	24 weeks	The use of rescue therapy (SUs, thiazolidinediones \[TZDs\], or insulin) was permitted only during the randomised treatment period of the trial (i.e. Visits 3 to 7), and was to be administered only if a patient had a 'confirmed' glucose level after an overnight fast.
Percentage of Patients With HbA1c Lowering by 0.5% at Week 24	Baseline and week 24	The percentage of patients with an HbA1c reduction from baseline greater than 0.5% at week 24 was calculated for each treatment arm. If a patient did not have an HbA1c value at week 24 they were considered a failure, so HbA1c reduction less than 0.5%.

Trial Locations

Locations (138): 1218.46.11003 Boehringer Ingelheim Investigational Site
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Edmonton, Alberta, Canada
1218.46.11002 Boehringer Ingelheim Investigational Site
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Red Deer, Alberta, Canada
1218.46.11006 Boehringer Ingelheim Investigational Site
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Vancouver, British Columbia, Canada
1218.46.11004 Boehringer Ingelheim Investigational Site
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Hamilton, Ontario, Canada
1218.46.38503 Boehringer Ingelheim Investigational Site
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Krapinske Toplice, Croatia
1218.46.11009 Boehringer Ingelheim Investigational Site
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Oshawa, Ontario, Canada
1218.46.11010 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1218.46.38505 Boehringer Ingelheim Investigational Site
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Rijeka, Croatia
1218.46.38506 Boehringer Ingelheim Investigational Site
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Zagreb, Croatia
1218.46.37202 Boehringer Ingelheim Investigational Site
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Pärnu, Estonia
1218.46.37203 Boehringer Ingelheim Investigational Site
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Tallin, Estonia
1218.46.3303D Boehringer Ingelheim Investigational Site
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Aire sur l'Aadour, France
1218.46.3308B Boehringer Ingelheim Investigational Site
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Bischheim, France
1218.46.3305A Boehringer Ingelheim Investigational Site
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Bourges, France
1218.46.3304F Boehringer Ingelheim Investigational Site
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Bousse, France
1218.46.3306D Boehringer Ingelheim Investigational Site
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Carresse Cassaber, France
1218.46.3308C Boehringer Ingelheim Investigational Site
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Gambsheim, France
1218.46.3305D Boehringer Ingelheim Investigational Site
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Garchizy, France
1218.46.3301A Boehringer Ingelheim Investigational Site
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Grenoble cédex, France
1218.46.3305B Boehringer Ingelheim Investigational Site
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Guerigny, France
1218.46.3304A Boehringer Ingelheim Investigational Site
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Jarny, France
1218.46.3302D Boehringer Ingelheim Investigational Site
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La Riche, France
1218.46.3307A Boehringer Ingelheim Investigational Site
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La Seyne sur Mer, France
1218.46.3307E Boehringer Ingelheim Investigational Site
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La Seyne sur Mer, France
1218.46.3303C Boehringer Ingelheim Investigational Site
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Mont de Marsan, France
1218.46.3303E Boehringer Ingelheim Investigational Site
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Mont de Marsan, France
1218.46.3304C Boehringer Ingelheim Investigational Site
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Moutiers, France
1218.46.3308F Boehringer Ingelheim Investigational Site
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Mundolsheim, France
1218.46.49008 Boehringer Ingelheim Investigational Site
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Neuwied, Germany
1218.46.3304E Boehringer Ingelheim Investigational Site
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Pont à Mousson, France
1218.46.3303B Boehringer Ingelheim Investigational Site
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St Martin d'Oney, France
1218.46.3308A Boehringer Ingelheim Investigational Site
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Strasbourg, France
1218.46.3308E Boehringer Ingelheim Investigational Site
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Strasbourg, France
1218.46.3307B Boehringer Ingelheim Investigational Site
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Toulon, France
1218.46.3307D Boehringer Ingelheim Investigational Site
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Toulon, France
1218.46.3302A Boehringer Ingelheim Investigational Site
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Tours, France
1218.46.3304H Boehringer Ingelheim Investigational Site
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Vandoeuvre les Nancy, France
1218.46.49001 Boehringer Ingelheim Investigational Site
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Bad Mergentheim, Germany
1218.46.49003 Boehringer Ingelheim Investigational Site
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München, Germany
1218.46.49007 Boehringer Ingelheim Investigational Site
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Schauenburg, Germany
1218.46.91009 Boehringer Ingelheim Investigational Site
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Aurangabad, India
1218.46.91007 Boehringer Ingelheim Investigational Site
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Babgalore, India
1218.46.91001 Boehringer Ingelheim Investigational Site
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Bangalore, India
1218.46.91004 Boehringer Ingelheim Investigational Site
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Bangalore, India
1218.46.91012 Boehringer Ingelheim Investigational Site
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Bangalore, India
1218.46.91011 Boehringer Ingelheim Investigational Site
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Bhopal, India
1218.46.91020 Boehringer Ingelheim Investigational Site
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Chennai, India
1218.46.91008 Boehringer Ingelheim Investigational Site
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Jaipur, India
1218.46.91019 Boehringer Ingelheim Investigational Site
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Madurai, India
1218.46.91013 Boehringer Ingelheim Investigational Site
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Maharashtra, India
1218.46.91002 Boehringer Ingelheim Investigational Site
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Manipal, India
1218.46.91015 Boehringer Ingelheim Investigational Site
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Mumbai, India
1218.46.91014 Boehringer Ingelheim Investigational Site
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Nagpur, India
1218.46.91017 Boehringer Ingelheim Investigational Site
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New Delhi, India
1218.46.91016 Boehringer Ingelheim Investigational Site
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P.O Trivandrum, India
1218.46.91010 Boehringer Ingelheim Investigational Site
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Pune, India
1218.46.91006 Boehringer Ingelheim Investigational Site
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West Bengal, India
1218.46.37004 Boehringer Ingelheim Investigational Site
🇱🇹
Kaunas, Lithuania
1218.46.37003 Boehringer Ingelheim Investigational Site
🇱🇹
Vilnius, Lithuania
1218.46.52006 Boehringer Ingelheim Investigational Site
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Aguascalientes, Mexico
1218.46.52002 Boehringer Ingelheim Investigational Site
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Cuernavaca, Mexico
1218.46.52003 Boehringer Ingelheim Investigational Site
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Guadalajara, Mexico
1218.46.52004 Boehringer Ingelheim Investigational Site
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Guadalajara, Mexico
1218.46.52007 Boehringer Ingelheim Investigational Site
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Mexico, Mexico
1218.46.52008 Boehringer Ingelheim Investigational Site
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Mexico, Mexico
1218.46.52001 Boehringer Ingelheim Investigational Site
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Pachuca, Mexico
1218.46.52010 Boehringer Ingelheim Investigational Site
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Tijuana, Mexico
1218.46.52009 Boehringer Ingelheim Investigational Site
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Veracruz, Mexico
1218.46.31004 Boehringer Ingelheim Investigational Site
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's Hertogenbosch, Netherlands
1218.46.31005 Boehringer Ingelheim Investigational Site
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's Hertogenbosch, Netherlands
1218.46.31001 Boehringer Ingelheim Investigational Site
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Almere, Netherlands
1218.46.31002 Boehringer Ingelheim Investigational Site
🇳🇱
Beek en Donk, Netherlands
1218.46.31011 Boehringer Ingelheim Investigational Site
🇳🇱
Eindhoven, Netherlands
1218.46.31012 Boehringer Ingelheim Investigational Site
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Leiderdrop, Netherlands
1218.46.31016 Boehringer Ingelheim Investigational Site
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Nijmegen, Netherlands
1218.46.31009 Boehringer Ingelheim Investigational Site
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Rotterdam, Netherlands
1218.46.31014 Boehringer Ingelheim Investigational Site
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Velp, Netherlands
1218.46.31015 Boehringer Ingelheim Investigational Site
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Zoetermeer, Netherlands
1218.46.40001 Boehringer Ingelheim Investigational Site
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Alba Iulia, Romania
1218.46.40005 Boehringer Ingelheim Investigational Site
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Galati, Romania
1218.46.40002 Boehringer Ingelheim Investigational Site
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Ploiesti, Romania
1218.46.40004 Boehringer Ingelheim Investigational Site
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Satu Mare, Romania
1218.46.70005 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.46.70003 Boehringer Ingelheim Investigational Site
🇷🇺
Moscow, Russian Federation
1218.46.2162A Boehringer Ingelheim Investigational Site
🇹🇳
Bab Sâadoun Tunis, Tunisia
1218.46.2161A Boehringer Ingelheim Investigational Site
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Tunis, Tunisia
1218.46.2161B Boehringer Ingelheim Investigational Site
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Tunis, Tunisia
1218.46.2163A Boehringer Ingelheim Investigational Site
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Tunis, Tunisia
1218.46.2163B Boehringer Ingelheim Investigational Site
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Tunis, Tunisia
1218.46.38003 Boehringer Ingelheim Investigational Site
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Kiev, Ukraine
1218.46.38001 Boehringer Ingelheim Investigational Site
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Lviv, Ukraine
1218.46.38005 Boehringer Ingelheim Investigational Site
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Lvov, Ukraine
1218.46.38004 Boehringer Ingelheim Investigational Site
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Odesa, Ukraine
1218.46.38006 Boehringer Ingelheim Investigational Site
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Vinnitsa, Ukraine
1218.46.11008 Boehringer Ingelheim Investigational Site
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Winnipeg, Manitoba, Canada
1218.46.38501 Boehringer Ingelheim Investigational Site
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Sisak, Croatia
1218.46.3305C Boehringer Ingelheim Investigational Site
🇫🇷
Nevers, France
1218.46.38504 Boehringer Ingelheim Investigational Site
🇭🇷
Osijek, Croatia
1218.46.37201 Boehringer Ingelheim Investigational Site
🇪🇪
Tallin, Estonia
1218.46.40003 Boehringer Ingelheim Investigational Site
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Oradea, Romania
1218.46.3302E Boehringer Ingelheim Investigational Site
🇫🇷
Savonnières, France
1218.46.3308D Boehringer Ingelheim Investigational Site
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Strasbourg, France
1218.46.49006 Boehringer Ingelheim Investigational Site
🇩🇪
Köln, Germany
1218.46.91018 Boehringer Ingelheim Investigational Site
🇮🇳
Hyderadad, India
1218.46.91003 Boehringer Ingelheim Investigational Site
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Chennai, India
1218.46.70006 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.46.46003 Boehringer Ingelheim Investigational Site
🇸🇪
Malmo, Sweden
1218.46.46004 Boehringer Ingelheim Investigational Site
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Goteborg, Sweden
1218.46.46005 Boehringer Ingelheim Investigational Site
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Stockholm, Sweden
1218.46.46001 Boehringer Ingelheim Investigational Site
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Uppsala, Sweden
1218.46.11005 Boehringer Ingelheim Investigational Site
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Calgary, Alberta, Canada
1218.46.11007 Boehringer Ingelheim Investigational Site
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Oakville, Ontario, Canada
1218.46.38502 Boehringer Ingelheim Investigational Site
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Karlovac, Croatia
1218.46.3305G Boehringer Ingelheim Investigational Site
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Lury, France
1218.46.3304D Boehringer Ingelheim Investigational Site
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Mars la Tour, France
1218.46.3303A Boehringer Ingelheim Investigational Site
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Mont de Marsan, France
1218.46.3304B Boehringer Ingelheim Investigational Site
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Mondelange, France
1218.46.3305E Boehringer Ingelheim Investigational Site
🇫🇷
Nevers, France
1218.46.3306A Boehringer Ingelheim Investigational Site
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Ortez, France
1218.46.3306C Boehringer Ingelheim Investigational Site
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Orthez, France
1218.46.3306E Boehringer Ingelheim Investigational Site
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Orthez, France
1218.46.3306F Boehringer Ingelheim Investigational Site
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Orthez, France
1218.46.3306B Boehringer Ingelheim Investigational Site
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Salies de Bearn, France
1218.46.3302B Boehringer Ingelheim Investigational Site
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Saint Avertin, France
1218.46.3302C Boehringer Ingelheim Investigational Site
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Saint Avertin, France
1218.46.3307C Boehringer Ingelheim Investigational Site
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Toulon, France
1218.46.49002 Boehringer Ingelheim Investigational Site
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Bad Dürrheim-Sunthausen, Germany
1218.46.37001 Boehringer Ingelheim Investigational Site
🇱🇹
Kaunas, Lithuania
1218.46.31010 Boehringer Ingelheim Investigational Site
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Breda, Netherlands
1218.46.31008 Boehringer Ingelheim Investigational Site
🇳🇱
Beek, Netherlands
1218.46.31013 Boehringer Ingelheim Investigational Site
🇳🇱
Groningen, Netherlands
1218.46.70001 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.46.70002 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.46.46002 Boehringer Ingelheim Investigational Site
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Goteborg, Sweden
1218.46.70007 Boehringer Ingelheim Investigational Site
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St. Petersburg, Russian Federation
1218.46.38002 Boehringer Ingelheim Investigational Site
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Odessa, Ukraine
1218.46.70004 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation
1218.46.70008 Boehringer Ingelheim Investigational Site
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Moscow, Russian Federation