Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Linagliptin
Drug: Placebo

Registration Number: NCT00954447

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1263

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linagliptin	Linagliptin	patient receives a tablet with intended final marketed dose
Placebo	Placebo	patient receives a tablet identical to those containing Linagliptin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c After 24 Weeks	Baseline and 24 weeks	HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)

Secondary Outcome Measures

Name	Time	Method
Number of Patients With HbA1c < 7.0 Percent	24 and 52 weeks
Number of Patients Lowering HbA1c by at Least 0.5 Percent	24 and 52 weeks
Change From Baseline in HbA1c by Visit at Week 6	Baseline and 6 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 12	Baseline and 12 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 18	Baseline and 18 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 32	Baseline and 32 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 40	Baseline and 40 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in HbA1c by Visit at Week 52	Baseline and 52 weeks	Means adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 Weeks of Treatment	Baseline and 24 weeks	Means adjusted for treatment, baseline HbA1c, baseline FPG, categorical renal function impairment and concomitant OADs
Change From Baseline in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment	Baseline and 52 weeks
Change From Baseline in FPG	Baseline, 6, 12, 18, 24, 32 and 40 weeks
Change From Baseline in Mean Insulin Dose at 52 Weeks of Treatment	Baseline and 52 weeks	Means adjusted for treatment, continous baseline HbA1c, continous baseline weight, continous baseline Insulin, categorical renal function impairment and concomitant OADs
Change From Baseline in Weighted Mean Daily Glucose After 24 and 52 Weeks of Treatment	Baseline, 24 and 52 weeks	Mean Daily Glucose was calculated using the 8-point blood glucose profile
Change From Baseline in Incremental Post-prandial Glucose (iPPG) After 24 Weeks of Treatment	Baseline and 24 weeks: post-breakfast, post-lunch, post-dinner

Trial Locations

Locations (169): 1218.36.01005 Boehringer Ingelheim Investigational Site
🇺🇸
Statesville, North Carolina, United States
1218.36.54004 Boehringer Ingelheim Investigational Site
🇦🇷
Córdoba, Argentina
1218.36.32002 Boehringer Ingelheim Investigational Site
🇧🇪
Edegem, Belgium
1218.36.320099 Boehringer Ingelheim Investigational Site
🇧🇪
Edegem, Belgium
1218.36.32006 Boehringer Ingelheim Investigational Site
🇧🇪
Sint-Gillis-Waas, Belgium
1218.36.02002 Boehringer Ingelheim Investigational Site
🇨🇦
Halifax, Nova Scotia, Canada
1218.36.42007 Boehringer Ingelheim Investigational Site
🇨🇿
Zlin, Czech Republic
1218.36.35807 Boehringer Ingelheim Investigational Site
🇫🇮
Joensuu, Finland
1218.36.35805 Boehringer Ingelheim Investigational Site
🇫🇮
Tampere, Finland
1218.36.30011 Boehringer Ingelheim Investigational Site
🇬🇷
Larissa, Greece
1218.36.31001 Boehringer Ingelheim Investigational Site
🇳🇱
Almere, Netherlands
1218.36.31002 Boehringer Ingelheim Investigational Site
🇳🇱
Ewijk, Netherlands
1218.36.70001 Boehringer Ingelheim Investigational Site
🇷🇺
Samara, Russian Federation
1218.36.31005 Boehringer Ingelheim Investigational Site
🇳🇱
Wildervank, Netherlands
1218.36.42106 Boehringer Ingelheim Investigational Site
🇸🇰
Trebisov, Slovakia
1218.36.88610 Boehringer Ingelheim Investigational Site
🇨🇳
Changhua, Taiwan
1218.36.88609 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei City, Taiwan
1218.36.34001 Boehringer Ingelheim Investigational Site
🇪🇸
Bercelona, Spain
1218.36.01065 Boehringer Ingelheim Investigational Site
🇺🇸
Fresno, California, United States
1218.36.01043 Boehringer Ingelheim Investigational Site
🇺🇸
Escondido, California, United States
1218.36.01056 Boehringer Ingelheim Investigational Site
🇺🇸
Waterbury, Connecticut, United States
1218.36.01048 Boehringer Ingelheim Investigational Site
🇺🇸
Los Angeles, California, United States
1218.36.01040 Boehringer Ingelheim Investigational Site
🇺🇸
Kansas City, Missouri, United States
1218.36.01006 Boehringer Ingelheim Investigational Site
🇺🇸
Burlington, North Carolina, United States
1218.36.01034 Boehringer Ingelheim Investigational Site
🇺🇸
St. Peters, Missouri, United States
1218.36.01008 Boehringer Ingelheim Investigational Site
🇺🇸
Santa Ana, California, United States
1218.36.01020 Boehringer Ingelheim Investigational Site
🇺🇸
Simpsonville, South Carolina, United States
1218.36.01037 Boehringer Ingelheim Investigational Site
🇺🇸
Ponte Vedra, Florida, United States
1218.36.01051 Boehringer Ingelheim Investigational Site
🇺🇸
Escondido, California, United States
1218.36.01029 Boehringer Ingelheim Investigational Site
🇺🇸
St. Louis, Missouri, United States
1218.36.01055 Boehringer Ingelheim Investigational Site
🇺🇸
Honolulu, Hawaii, United States
1218.36.01021 Boehringer Ingelheim Investigational Site
🇺🇸
Greenbrae, California, United States
1218.36.01053 Boehringer Ingelheim Investigational Site
🇺🇸
New Hartford, New York, United States
1218.36.01038 Boehringer Ingelheim Investigational Site
🇺🇸
Dallas, Texas, United States
1218.36.01009 Boehringer Ingelheim Investigational Site
🇺🇸
Roswell, Georgia, United States
1218.36.01039 Boehringer Ingelheim Investigational Site
🇺🇸
Tulsa, Oklahoma, United States
1218.36.02011 Boehringer Ingelheim Investigational Site
🇨🇦
Victoria, British Columbia, Canada
1218.36.55003 Boehringer Ingelheim Investigational Site
🇧🇷
Belém, Brazil
1218.36.01025 Boehringer Ingelheim Investigational Site
🇺🇸
Hickory, North Carolina, United States
1218.36.01027 Boehringer Ingelheim Investigational Site
🇺🇸
Spokane, Washington, United States
1218.36.54002 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1218.36.01003 Boehringer Ingelheim Investigational Site
🇺🇸
Kingsport, Tennessee, United States
1218.36.54001 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1218.36.01024 Boehringer Ingelheim Investigational Site
🇺🇸
Lakewood, Washington, United States
1218.36.42001 Boehringer Ingelheim Investigational Site
🇨🇿
Neratovice, Czech Republic
1218.36.02010 Boehringer Ingelheim Investigational Site
🇨🇦
Calgary, Alberta, Canada
1218.36.02004 Boehringer Ingelheim Investigational Site
🇨🇦
Vancouver, British Columbia, Canada
1218.36.01064 Boehringer Ingelheim Investigational Site
🇺🇸
Richmond, Virginia, United States
1218.36.54003 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1218.36.01019 Boehringer Ingelheim Investigational Site
🇺🇸
Altoona, Pennsylvania, United States
1218.36.30003 Boehringer Ingelheim Investigational Site
🇬🇷
Athens, Greece
1218.36.30005 Boehringer Ingelheim Investigational Site
🇬🇷
Thessaloniki, Greece
1218.36.01058 Boehringer Ingelheim Investigational Site
🇺🇸
San Diego, California, United States
1218.36.01015 Boehringer Ingelheim Investigational Site
🇺🇸
Cincinnati, Ohio, United States
1218.36.01016 Boehringer Ingelheim Investigational Site
🇺🇸
Houston, Texas, United States
1218.36.01026 Boehringer Ingelheim Investigational Site
🇺🇸
Salt Lake city, Utah, United States
1218.36.39002 Boehringer Ingelheim Investigational Site
🇮🇹
Ferrara, Italy
1218.36.39005 Boehringer Ingelheim Investigational Site
🇮🇹
Milano, Italy
1218.36.01018 Boehringer Ingelheim Investigational Site
🇺🇸
Omaha, Nebraska, United States
1218.36.55001 Boehringer Ingelheim Investigational Site
🇧🇷
São Paulo, Brazil
1218.36.55004 Boehringer Ingelheim Investigational Site
🇧🇷
Porto Alegre, Brazil
1218.36.02009 Boehringer Ingelheim Investigational Site
🇨🇦
Hamilton, Ontario, Canada
1218.36.01013 Boehringer Ingelheim Investigational Site
🇺🇸
Los Angeles, California, United States
1218.36.01054 Boehringer Ingelheim Investigational Site
🇺🇸
Clearwater, Florida, United States
1218.36.01035 Boehringer Ingelheim Investigational Site
🇺🇸
Inverness, Florida, United States
1218.36.01042 Boehringer Ingelheim Investigational Site
🇺🇸
New Port Richey, Florida, United States
1218.36.01063 Boehringer Ingelheim Investigational Site
🇺🇸
Pembroke Pines, Florida, United States
1218.36.01032 Boehringer Ingelheim Investigational Site
🇺🇸
St. Cloud, Florida, United States
1218.36.01047 Boehringer Ingelheim Investigational Site
🇺🇸
Decatur, Georgia, United States
1218.36.01011 Boehringer Ingelheim Investigational Site
🇺🇸
Paducah, Kentucky, United States
1218.36.01062 Boehringer Ingelheim Investigational Site
🇺🇸
Tacoma, Washington, United States
1218.36.01007 Boehringer Ingelheim Investigational Site
🇺🇸
Renton, Washington, United States
1218.36.01049 Boehringer Ingelheim Investigational Site
🇺🇸
St. Petersburg, Florida, United States
1218.36.01010 Boehringer Ingelheim Investigational Site
🇺🇸
Miami, Florida, United States
1218.36.01014 Boehringer Ingelheim Investigational Site
🇺🇸
Chicago, Illinois, United States
1218.36.01036 Boehringer Ingelheim Investigational Site
🇺🇸
Atlanta, Georgia, United States
1218.36.01012 Boehringer Ingelheim Investigational Site
🇺🇸
Norristown, Pennsylvania, United States
1218.36.01041 Boehringer Ingelheim Investigational Site
🇺🇸
Bennington, Vermont, United States
1218.36.54005 Boehringer Ingelheim Investigational Site
🇦🇷
Capital Federal, Argentina
1218.36.55002 Boehringer Ingelheim Investigational Site
🇧🇷
São Paulo, Brazil
1218.36.02008 Boehringer Ingelheim Investigational Site
🇨🇦
Sarnia, Ontario, Canada
1218.36.02001 Boehringer Ingelheim Investigational Site
🇨🇦
Laval, Quebec, Canada
1218.36.42004 Boehringer Ingelheim Investigational Site
🇨🇿
Brno, Czech Republic
1218.36.02007 Boehringer Ingelheim Investigational Site
🇨🇦
Toronto, Ontario, Canada
1218.36.02005 Boehringer Ingelheim Investigational Site
🇨🇦
Kingston, Ontario, Canada
1218.36.02006 Boehringer Ingelheim Investigational Site
🇨🇦
St. John's, Newfoundland and Labrador, Canada
1218.36.02003 Boehringer Ingelheim Investigational Site
🇨🇦
Montreal, Quebec, Canada
1218.36.42005 Boehringer Ingelheim Investigational Site
🇨🇿
Hodonin, Czech Republic
1218.36.42002 Boehringer Ingelheim Investigational Site
🇨🇿
Mlada Boleslav, Czech Republic
1218.36.42006 Boehringer Ingelheim Investigational Site
🇨🇿
Breclav, Czech Republic
1218.36.35802 Boehringer Ingelheim Investigational Site
🇫🇮
Kuopio, Finland
1218.36.35803 Boehringer Ingelheim Investigational Site
🇫🇮
Oulu, Finland
1218.36.35804 Boehringer Ingelheim Investigational Site
🇫🇮
Turku, Finland
1218.36.49001 Boehringer Ingelheim Investigational Site
🇩🇪
Berlin, Germany
1218.36.35806 Boehringer Ingelheim Investigational Site
🇫🇮
Vantaa, Finland
1218.36.49002 Boehringer Ingelheim Investigational Site
🇩🇪
Berlin, Germany
1218.36.49009 Boehringer Ingelheim Investigational Site
🇩🇪
Bosenheim, Germany
1218.36.49004 Boehringer Ingelheim Investigational Site
🇩🇪
Dortmund, Germany
1218.36.49006 Boehringer Ingelheim Investigational Site
🇩🇪
Dresden, Germany
1218.36.49010 Boehringer Ingelheim Investigational Site
🇩🇪
Berlin, Germany
1218.36.49014 Boehringer Ingelheim Investigational Site
🇩🇪
Wangen, Germany
1218.36.49017 Boehringer Ingelheim Investigational Site
🇩🇪
Köln, Germany
1218.36.49012 Boehringer Ingelheim Investigational Site
🇩🇪
Magdeburg, Germany
1218.36.49005 Boehringer Ingelheim Investigational Site
🇩🇪
Mainz, Germany
1218.36.49018 Boehringer Ingelheim Investigational Site
🇩🇪
Neuwied, Germany
1218.36.49008 Boehringer Ingelheim Investigational Site
🇩🇪
Pirna, Germany
1218.36.49003 Boehringer Ingelheim Investigational Site
🇩🇪
Unterschneidheim, Germany
1218.36.49019 Boehringer Ingelheim Investigational Site
🇩🇪
Sulzbach-Rosenberg, Germany
1218.36.49015 Boehringer Ingelheim Investigational Site
🇩🇪
Westerkappeln, Germany
1218.36.49011 Boehringer Ingelheim Investigational Site
🇩🇪
Wangen, Germany
1218.36.30007 Boehringer Ingelheim Investigational Site
🇬🇷
Athens, Greece
1218.36.30010 Boehringer Ingelheim Investigational Site
🇬🇷
Athens, Greece
1218.36.30002 Boehringer Ingelheim Investigational Site
🇬🇷
Nikaia, Greece
1218.36.39004 Boehringer Ingelheim Investigational Site
🇮🇹
Genova, Italy
1218.36.39003 Boehringer Ingelheim Investigational Site
🇮🇹
Ferrara, Italy
1218.36.39001 Boehringer Ingelheim Investigational Site
🇮🇹
Pordenone, Italy
1218.36.39007 Boehringer Ingelheim Investigational Site
🇮🇹
Siena, Italy
1218.36.39006 Boehringer Ingelheim Investigational Site
🇮🇹
Siracusa, Italy
1218.36.82004 Boehringer Ingelheim Investigational Site
🇰🇷
Daegu, Korea, Republic of
1218.36.82009 Boehringer Ingelheim Investigational Site
🇰🇷
Daegu, Korea, Republic of
1218.36.82001 Boehringer Ingelheim Investigational Site
🇰🇷
Pusan, Korea, Republic of
1218.36.82008 Boehringer Ingelheim Investigational Site
🇰🇷
Incheon, Korea, Republic of
1218.36.82007 Boehringer Ingelheim Investigational Site
🇰🇷
Jeonju, Korea, Republic of
1218.36.82002 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1218.36.82006 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1218.36.82005 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1218.36.82010 Boehringer Ingelheim Investigational Site
🇰🇷
Suwon, Korea, Republic of
1218.36.52005 Boehringer Ingelheim Investigational Site
🇲🇽
Tijuana, Mexico
1218.36.52002 Boehringer Ingelheim Investigational Site
🇲🇽
Pachuca, Mexico
1218.36.31008 Boehringer Ingelheim Investigational Site
🇳🇱
's Hertogenbosch, Netherlands
1218.36.52004 Boehringer Ingelheim Investigational Site
🇲🇽
San Luis Potosi, Mexico
1218.36.31006 Boehringer Ingelheim Investigational Site
🇳🇱
Beek, Netherlands
1218.36.31004 Boehringer Ingelheim Investigational Site
🇳🇱
Oude Pekela, Netherlands
1218.36.31007 Boehringer Ingelheim Investigational Site
🇳🇱
Roelofarendsveen, Netherlands
1218.36.47002 Boehringer Ingelheim Investigational Site
🇳🇴
Bergen, Norway
1218.36.47004 Boehringer Ingelheim Investigational Site
🇳🇴
Oslo, Norway
1218.36.47001 Boehringer Ingelheim Investigational Site
🇳🇴
Stavanger, Norway
1218.36.47005 Boehringer Ingelheim Investigational Site
🇳🇴
Hamar, Norway
1218.36.47006 Boehringer Ingelheim Investigational Site
🇳🇴
Elverum, Norway
1218.36.51003 Boehringer Ingelheim Investigational Site
🇵🇪
Lima, Peru
1218.36.70003 Boehringer Ingelheim Investigational Site
🇷🇺
Moscow, Russian Federation
1218.36.70007 Boehringer Ingelheim Investigational Site
🇷🇺
Smolensk, Russian Federation
1218.36.70005 Boehringer Ingelheim Investigational Site
🇷🇺
St. Petersburg, Russian Federation
1218.36.70006 Boehringer Ingelheim Investigational Site
🇷🇺
Yaroslavl, Russian Federation
1218.36.42103 Boehringer Ingelheim Investigational Site
🇸🇰
Banska Bystrica, Slovakia
1218.36.42104 Boehringer Ingelheim Investigational Site
🇸🇰
Bratislava, Slovakia
1218.36.42101 Boehringer Ingelheim Investigational Site
🇸🇰
Bratislava, Slovakia
1218.36.42102 Boehringer Ingelheim Investigational Site
🇸🇰
Bratislava, Slovakia
1218.36.42105 Boehringer Ingelheim Investigational Site
🇸🇰
Presov, Slovakia
1218.36.70002 Boehringer Ingelheim Investigational Site
🇷🇺
Moscow, Russian Federation
1218.36.34002 Boehringer Ingelheim Investigational Site
🇪🇸
Badia del Vallés (Barcelona), Spain
1218.36.34005 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1218.36.34010 Boehringer Ingelheim Investigational Site
🇪🇸
Barcelona, Spain
1218.36.88607 Boehringer Ingelheim Investigational Site
🇨🇳
Kaohsiung, Taiwan
1218.36.34007 Boehringer Ingelheim Investigational Site
🇪🇸
Borges del Camp (Tarragona), Spain
1218.36.34004 Boehringer Ingelheim Investigational Site
🇪🇸
L'Hospitalet de Llobregat (Barcelona), Spain
1218.36.34011 Boehringer Ingelheim Investigational Site
🇪🇸
Sevilla, Spain
1218.36.34003 Boehringer Ingelheim Investigational Site
🇪🇸
Centelles (Barcelona), Spain
1218.36.34009 Boehringer Ingelheim Investigational Site
🇪🇸
Tàrrega (Lleida), Spain
1218.36.34006 Boehringer Ingelheim Investigational Site
🇪🇸
Vic (Barcelona), Spain
1218.36.88601 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1218.36.88606 Boehringer Ingelheim Investigational Site
🇨🇳
Tainan, Taiwan
1218.36.88603 Boehringer Ingelheim Investigational Site
🇨🇳
Taichung, Taiwan
1218.36.88605 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1218.36.88608 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1218.36.88602 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1218.36.88604 Boehringer Ingelheim Investigational Site
🇨🇳
Taipei, Taiwan
1218.36.82003 Boehringer Ingelheim Investigational Site
🇰🇷
Seoul, Korea, Republic of
1218.36.01004 Boehringer Ingelheim Investigational Site
🇺🇸
Greer, South Carolina, United States