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Comprehensive Add on Study in Japan

NCT ID: NCT01204294

Last Updated: 2014-03-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

574 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-01-31

Brief Summary

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The objective of the current study is to investigate the safety and efficacy of linagliptin (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one approved antidiabetic drug.

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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

NONE

Study Groups

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Bigu+Lina

biguanide plus linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin once daily

Glin+Lina

glinide plus linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin once daily

Glit+Lina

glitazone plus linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin once daily

SU+Lina

sulfonylurea plus linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin once daily

A-GI+Lina

alpha-glucosidase inhibitor plus linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Linagliptin once daily

SU+Met

sulfonylurea plus metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin twice or three time per day

A-GI+Met

alpha-glucosidase inhibitor plus metformin

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin twice or three time per day

Interventions

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Linagliptin

Linagliptin once daily

Intervention Type DRUG

Linagliptin

Linagliptin once daily

Intervention Type DRUG

Metformin

Metformin twice or three time per day

Intervention Type DRUG

Metformin

Metformin twice or three time per day

Intervention Type DRUG

Linagliptin

Linagliptin once daily

Intervention Type DRUG

Linagliptin

Linagliptin once daily

Intervention Type DRUG

Linagliptin

Linagliptin once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of type 2 diabetes mellitus
2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion Criteria

1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
2. Impaired hepatic function
3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate \<30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate \<60 ml/min (moderate renal impairment) at Visit 1
4. Treatment with anti-obesity drugs
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1218.78.008 Boehringer Ingelheim Investigational Site

Akishima, Tokyo, , Japan

Site Status

1218.78.030 Boehringer Ingelheim Investigational Site

Amagasaki, Hyogo, , Japan

Site Status

1218.78.017 Boehringer Ingelheim Investigational Site

Annaka, Gunma, , Japan

Site Status

1218.78.006 Boehringer Ingelheim Investigational Site

Aomori, Aomori, , Japan

Site Status

1218.78.007 Boehringer Ingelheim Investigational Site

Aomori, Aomori, , Japan

Site Status

1218.78.009 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1218.78.013 Boehringer Ingelheim Investigational Site

Chuo-ku, Tokyo, , Japan

Site Status

1218.78.032 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1218.78.040 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

Site Status

1218.78.037 Boehringer Ingelheim Investigational Site

Higashi Osaka, Osaka, , Japan

Site Status

1218.78.043 Boehringer Ingelheim Investigational Site

Hitachinaka, Ibaraki, , Japan

Site Status

1218.78.019 Boehringer Ingelheim Investigational Site

Isesaki, Gunma, , Japan

Site Status

1218.78.036 Boehringer Ingelheim Investigational Site

Kashiwara, Osaka, , Japan

Site Status

1218.78.026 Boehringer Ingelheim Investigational Site

Kasugai, Aichi, , Japan

Site Status

1218.78.038 Boehringer Ingelheim Investigational Site

Kawachinagano, Osaka, , Japan

Site Status

1218.78.021 Boehringer Ingelheim Investigational Site

Kitaazumi-gun, Nagano, , Japan

Site Status

1218.78.022 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

Site Status

1218.78.033 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

Site Status

1218.78.012 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, , Japan

Site Status

1218.78.041 Boehringer Ingelheim Investigational Site

Meguro-ku, Tokyo, , Japan

Site Status

1218.78.034 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

1218.78.035 Boehringer Ingelheim Investigational Site

Morioka, Iwate, , Japan

Site Status

1218.78.018 Boehringer Ingelheim Investigational Site

Moriya, Ibaraki, , Japan

Site Status

1218.78.024 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.78.025 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.78.027 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.78.028 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.78.031 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

Site Status

1218.78.039 Boehringer Ingelheim Investigational Site

Oita, Oita, , Japan

Site Status

1218.78.004 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, , Japan

Site Status

1218.78.016 Boehringer Ingelheim Investigational Site

Sagae, Yamagata, , Japan

Site Status

1218.78.001 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.78.020 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.78.042 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

1218.78.005 Boehringer Ingelheim Investigational Site

Shimajiri-gun, Okinawa, , Japan

Site Status

1218.78.014 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

1218.78.002 Boehringer Ingelheim Investigational Site

Shinjyuku-ku. Tokyo, , Japan

Site Status

1218.78.011 Boehringer Ingelheim Investigational Site

Shizuoka, Shizuoka, , Japan

Site Status

1218.78.003 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Site Status

1218.78.023 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

Site Status

1218.78.029 Boehringer Ingelheim Investigational Site

Tokorozawa, Saitama, , Japan

Site Status

1218.78.010 Boehringer Ingelheim Investigational Site

Tsuchiura, Ibaraki, , Japan

Site Status

1218.78.015 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, , Japan

Site Status

Countries

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Japan

Other Identifiers

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1218.78

Identifier Type: -

Identifier Source: org_study_id

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