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Japanese P III vs Voglibose and Placebo

NCT ID: NCT00654381

Last Updated: 2014-01-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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voglibose 0.2 mg three times a day (TID)

patient to receive a tablet containing 0.2 mg voglibose TID plus 2 placebo tablets matching BI 1356

Group Type ACTIVE_COMPARATOR

voglibose

Intervention Type DRUG

0.6 mg/daily

BI 1356 low dose

patient to receive a tablet containing BI 1356 and matching placebo plus 3 placebo tablets matching voglibose

Group Type EXPERIMENTAL

BI 1356

Intervention Type DRUG

5 mg/daily

BI 1356 high dose

patient to receive 2 tablets containing BI 1356 plus 3 placebo tablets matching voglibose

Group Type EXPERIMENTAL

BI 1356

Intervention Type DRUG

10 mg/daily

placebo

patient to receive 2 placebo tablets matching BI 1356 plus 3 placebo tablets matching voglibose

Group Type PLACEBO_COMPARATOR

voglibose placebo

Intervention Type DRUG

three times daily

BI 1356 placebo

Intervention Type DRUG

once daily

Interventions

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BI 1356

5 mg/daily

Intervention Type DRUG

BI 1356

10 mg/daily

Intervention Type DRUG

voglibose placebo

three times daily

Intervention Type DRUG

BI 1356 placebo

once daily

Intervention Type DRUG

voglibose

0.6 mg/daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.23.05 Boehringer Ingelheim Investigational Site

Asahi, Chiba, , Japan

Site Status

1218.23.06 Boehringer Ingelheim Investigational Site

Funabashi, Chiba, , Japan

Site Status

1218.23.21 Boehringer Ingelheim Investigational Site

Hitachinaka, Ibaraki, , Japan

Site Status

1218.23.44 Boehringer Ingelheim Investigational Site

Hitachiota, Ibaraki, , Japan

Site Status

1218.23.09 Boehringer Ingelheim Investigational Site

Imizu, Toyama, , Japan

Site Status

1218.23.45 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, , Japan

Site Status

1218.23.13 Boehringer Ingelheim Investigational Site

Izumisano, Osaka, , Japan

Site Status

1218.23.27 Boehringer Ingelheim Investigational Site

Kariya, Aichi, , Japan

Site Status

1218.23.47 Boehringer Ingelheim Investigational Site

Kitakatsushika-gun, Saitama, , Japan

Site Status

1218.23.39 Boehringer Ingelheim Investigational Site

Kitakyuushuu, Fukuoka, , Japan

Site Status

1218.23.02 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

Site Status

1218.23.03 Boehringer Ingelheim Investigational Site

Koriyama, Fukushima, , Japan

Site Status

1218.23.10 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

Site Status

1218.23.37 Boehringer Ingelheim Investigational Site

Marugame, Kagawa, , Japan

Site Status

1218.23.38 Boehringer Ingelheim Investigational Site

Marugame, Kagawa, , Japan

Site Status

1218.23.23 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

Site Status

1218.23.07 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, , Japan

Site Status

1218.23.25 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.23.26 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.23.28 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.23.29 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.23.30 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.23.04 Boehringer Ingelheim Investigational Site

Naka, Ibaraki, , Japan

Site Status

1218.23.15 Boehringer Ingelheim Investigational Site

Nishi-ku, Hiroshima, Hiroshima, , Japan

Site Status

1218.23.34 Boehringer Ingelheim Investigational Site

Nishi-ku, Sakai, Osaka, , Japan

Site Status

1218.23.22 Boehringer Ingelheim Investigational Site

Nishishinjyuku, Shinjyuku-ku, Tokyo, , Japan

Site Status

1218.23.16 Boehringer Ingelheim Investigational Site

Oita, Oita, , Japan

Site Status

1218.23.40 Boehringer Ingelheim Investigational Site

Oita, Oita, , Japan

Site Status

1218.23.36 Boehringer Ingelheim Investigational Site

Okayama, Okayama, , Japan

Site Status

1218.23.11 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.23.12 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.23.32 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.23.33 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.23.35 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

Site Status

1218.23.17 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.18 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.19 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.41 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.42 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.43 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.23.01 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

Site Status

1218.23.20 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

Site Status

1218.23.46 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1218.23.08 Boehringer Ingelheim Investigational Site

Shinjyuku-ku,Tokyo, , Japan

Site Status

1218.23.14 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1218.23.31 Boehringer Ingelheim Investigational Site

Takatsuki, Osaka, , Japan

Site Status

1218.23.48 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 22234149 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19732457 (View on PubMed)

Other Identifiers

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1218.23

Identifier Type: -

Identifier Source: org_study_id

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