Japanese P III vs Voglibose and Placebo

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: voglibose; Drug: BI 1356; Drug: voglibose placebo; Drug: BI 1356 placebo

• Registration Number: NCT00654381
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-08
• Primary Completion: 2010-01
• Results First Submitted: 2011-05-18
• Results First Submitted QC: 2011-07-05
• Results First Posted: 2011-08-02
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
voglibose 0.2 mg three times a day (TID)	voglibose	patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356
BI 1356 low dose	BI 1356	patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose
BI 1356 high dose	BI 1356	patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose
placebo	voglibose placebo	patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose
placebo	BI 1356 placebo	patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at Week 12	12 weeks	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in HbA1c at Week 26	26 weeks	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Examination of Long-term Safety of Linagliptin (52-week Treatment)	52 weeks	The incidence of AEs (Preferred Terms) with a frequency of 5% or more in the patients with type 2 diabetes mellitus who received linagliptin (5 mg or 10 mg) once daily for 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12	12 weeks	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26	26 weeks	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52	52 weeks	Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication
Relative Efficacy Response of HbA1c at Week 12	12 weeks	HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 12
Relative Efficacy Response of HbA1c at Week 26	26 weeks	HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 26
Relative Efficacy Response of HbA1c at Week 52	52 weeks	HbA1c value decreased below 7.0%, below 6.5% and reduction from baseline ≥0.5% at Week 52

Trial Locations

Locations (47)

1218.23.33 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.23.35 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.23.19 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.23.46 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1218.23.05 Boehringer Ingelheim Investigational Site; 🇯🇵 Asahi, Chiba, Japan

1218.23.44 Boehringer Ingelheim Investigational Site; 🇯🇵 Hitachiota, Ibaraki, Japan

1218.23.06 Boehringer Ingelheim Investigational Site; 🇯🇵 Funabashi, Chiba, Japan

1218.23.21 Boehringer Ingelheim Investigational Site; 🇯🇵 Hitachinaka, Ibaraki, Japan

1218.23.45 Boehringer Ingelheim Investigational Site; 🇯🇵 Inashiki-gun, Ibaraki, Japan

1218.23.13 Boehringer Ingelheim Investigational Site; 🇯🇵 Izumisano, Osaka, Japan

1218.23.27 Boehringer Ingelheim Investigational Site; 🇯🇵 Kariya, Aichi, Japan

1218.23.47 Boehringer Ingelheim Investigational Site; 🇯🇵 Kitakatsushika-gun, Saitama, Japan

1218.23.02 Boehringer Ingelheim Investigational Site; 🇯🇵 Koriyama, Fukushima, Japan

1218.23.03 Boehringer Ingelheim Investigational Site; 🇯🇵 Koriyama, Fukushima, Japan

1218.23.12 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.23.29 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.23.32 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.23.30 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.23.22 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan

1218.23.11 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka, Osaka, Japan

1218.23.41 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.23.42 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.23.18 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.23.43 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.23.01 Boehringer Ingelheim Investigational Site; 🇯🇵 Sendai, Miyagi, Japan

1218.23.20 Boehringer Ingelheim Investigational Site; 🇯🇵 Sendai, Miyagi, Japan

1218.23.08 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjyuku-ku,Tokyo, Japan

1218.23.14 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1218.23.31 Boehringer Ingelheim Investigational Site; 🇯🇵 Takatsuki, Osaka, Japan

1218.23.48 Boehringer Ingelheim Investigational Site; 🇯🇵 Yokohama, Kanagawa, Japan

1218.23.09 Boehringer Ingelheim Investigational Site; 🇯🇵 Imizu, Toyama, Japan

1218.23.39 Boehringer Ingelheim Investigational Site; 🇯🇵 Kitakyuushuu, Fukuoka, Japan

1218.23.10 Boehringer Ingelheim Investigational Site; 🇯🇵 Kyoto, Kyoto, Japan

1218.23.37 Boehringer Ingelheim Investigational Site; 🇯🇵 Marugame, Kagawa, Japan

1218.23.07 Boehringer Ingelheim Investigational Site; 🇯🇵 Meguro-ku, Tokyo, Japan

1218.23.23 Boehringer Ingelheim Investigational Site; 🇯🇵 Matsumoto, Nagano, Japan

1218.23.38 Boehringer Ingelheim Investigational Site; 🇯🇵 Marugame, Kagawa, Japan

1218.23.25 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.23.26 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.23.28 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.23.04 Boehringer Ingelheim Investigational Site; 🇯🇵 Naka, Ibaraki, Japan

1218.23.15 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishi-ku, Hiroshima, Hiroshima, Japan

1218.23.40 Boehringer Ingelheim Investigational Site; 🇯🇵 Oita, Oita, Japan

1218.23.34 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishi-ku, Sakai, Osaka, Japan

1218.23.16 Boehringer Ingelheim Investigational Site; 🇯🇵 Oita, Oita, Japan

1218.23.36 Boehringer Ingelheim Investigational Site; 🇯🇵 Okayama, Okayama, Japan

1218.23.17 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan