Clinical trial NCT00654381: Japanese P III vs Voglibose and Placebo
Official title: A Double-blind Phase III Study to Evaluate the Efficacy of BI 1356 5 mg and 10 mg vs. Placebo for 12 Weeks and vs. Voglibose 0.6 mg for 26 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control, Followed by an Extension Study to 52 Weeks to Evaluate Long-term Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 561
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.


Eligibility criteria: Inclusion criteria:

1. Japanese patients with a diagnosis of type 2 diabetes mellitus. Antidiabetic therapy has to be stable for at least 10 weeks before Visit 1.
2. Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at Visit 3 (beginning of the 2-week placebo run-in phase)
3. Age: \>= 20 and \<= 80
4. Body Mass Index (BMI) \<= 40 kg/m2

Exclusion criteria:

1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months before Visit 1
2. Impaired hepatic function
3. History of severe allergy/hypersensitivity
4. Treatment with anti-diabetic, anti obesity drugs, etc 3 months before Visit 1
5. Fasting blood glucose \>240 mg/dl (=13.3 mmol/L) at Visits 2 or 3

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in HbA1c at Week 26
timeFrame: 26 weeks
measure: Examination of Long-term Safety of Linagliptin (52-week Treatment)
timeFrame: 52 weeks
Secondary outcomes:
measure: Relative Efficacy Response of HbA1c at Week 12
timeFrame: 12 weeks
measure: Relative Efficacy Response of HbA1c at Week 26
timeFrame: 26 weeks
measure: Relative Efficacy Response of HbA1c at Week 52
timeFrame: 52 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
timeFrame: 26 weeks
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Asahi, Chiba
country: Japan
facility: 1218.23.05 Boehringer Ingelheim Investigational Site
city: Funabashi, Chiba
country: Japan
facility: 1218.23.06 Boehringer Ingelheim Investigational Site
city: Hitachinaka, Ibaraki
country: Japan
facility: 1218.23.21 Boehringer Ingelheim Investigational Site
city: Hitachiota, Ibaraki
country: Japan
facility: 1218.23.44 Boehringer Ingelheim Investigational Site
city: Imizu, Toyama
country: Japan
facility: 1218.23.09 Boehringer Ingelheim Investigational Site
city: Inashiki-gun, Ibaraki
country: Japan
facility: 1218.23.45 Boehringer Ingelheim Investigational Site
city: Izumisano, Osaka
country: Japan
facility: 1218.23.13 Boehringer Ingelheim Investigational Site
city: Kariya, Aichi
country: Japan
facility: 1218.23.27 Boehringer Ingelheim Investigational Site
city: Kitakatsushika-gun, Saitama
country: Japan
facility: 1218.23.47 Boehringer Ingelheim Investigational Site
city: Kitakyuushuu, Fukuoka
country: Japan
facility: 1218.23.39 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1218.23.02 Boehringer Ingelheim Investigational Site
city: Koriyama, Fukushima
country: Japan
facility: 1218.23.03 Boehringer Ingelheim Investigational Site
city: Kyoto, Kyoto
country: Japan
facility: 1218.23.10 Boehringer Ingelheim Investigational Site
city: Marugame, Kagawa
country: Japan
facility: 1218.23.37 Boehringer Ingelheim Investigational Site
city: Marugame, Kagawa
country: Japan
facility: 1218.23.38 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1218.23.23 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 1218.23.07 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.23.25 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.23.26 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.23.28 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.23.29 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.23.30 Boehringer Ingelheim Investigational Site
city: Naka, Ibaraki
country: Japan
facility: 1218.23.04 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Hiroshima, Hiroshima
country: Japan
facility: 1218.23.15 Boehringer Ingelheim Investigational Site
city: Nishi-ku, Sakai, Osaka
country: Japan
facility: 1218.23.34 Boehringer Ingelheim Investigational Site
city: Nishishinjyuku, Shinjyuku-ku, Tokyo
country: Japan
facility: 1218.23.22 Boehringer Ingelheim Investigational Site
city: Oita, Oita
country: Japan
facility: 1218.23.16 Boehringer Ingelheim Investigational Site
city: Oita, Oita
country: Japan
facility: 1218.23.40 Boehringer Ingelheim Investigational Site
city: Okayama, Okayama
country: Japan
facility: 1218.23.36 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.23.11 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.23.12 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.23.32 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.23.33 Boehringer Ingelheim Investigational Site
city: Osaka, Osaka
country: Japan
facility: 1218.23.35 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.17 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.18 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.19 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.41 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.42 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.23.43 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1218.23.01 Boehringer Ingelheim Investigational Site
city: Sendai, Miyagi
country: Japan
facility: 1218.23.20 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1218.23.46 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku,Tokyo
country: Japan
facility: 1218.23.08 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1218.23.14 Boehringer Ingelheim Investigational Site
city: Takatsuki, Osaka
country: Japan
facility: 1218.23.31 Boehringer Ingelheim Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: 1218.23.48 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Johansen OE, Neubacher D, von Eynatten M, Patel S, Woerle HJ. Cardiovascular safety with linagliptin in patients with type 2 diabetes mellitus: a pre-specified, prospective, and adjudicated meta-analysis of a phase 3 programme. Cardiovasc Diabetol. 2012 Jan 10;11:3. doi: 10.1186/1475-2840-11-3.
citation: Horie Y, Hayashi N, Dugi K, Takeuchi M. Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo. Trials. 2009 Sep 5;10:82. doi: 10.1186/1745-6215-10-82.