Clinical trial NCT01204294: Comprehensive Add on Study in Japan
Official title: An Open Label, Randomised, Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Background Mono-therapy With an Approved Antidiabetic Drug
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2010-09-17
Enrollment: 574
Sex: ALL
Minimum age (years): 20
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: The first drug administration through 7 days after the last drug administration, up to 382 days
Secondary outcomes:
measure: Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Akishima, Tokyo
country: Japan
facility: 1218.78.008 Boehringer Ingelheim Investigational Site
city: Amagasaki, Hyogo
country: Japan
facility: 1218.78.030 Boehringer Ingelheim Investigational Site
city: Annaka, Gunma
country: Japan
facility: 1218.78.017 Boehringer Ingelheim Investigational Site
city: Aomori, Aomori
country: Japan
facility: 1218.78.006 Boehringer Ingelheim Investigational Site
city: Aomori, Aomori
country: Japan
facility: 1218.78.007 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1218.78.009 Boehringer Ingelheim Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: 1218.78.013 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 1218.78.032 Boehringer Ingelheim Investigational Site
city: Fukuoka, Fukuoka
country: Japan
facility: 1218.78.040 Boehringer Ingelheim Investigational Site
city: Higashi Osaka, Osaka
country: Japan
facility: 1218.78.037 Boehringer Ingelheim Investigational Site
city: Hitachinaka, Ibaraki
country: Japan
facility: 1218.78.043 Boehringer Ingelheim Investigational Site
city: Isesaki, Gunma
country: Japan
facility: 1218.78.019 Boehringer Ingelheim Investigational Site
city: Kashiwara, Osaka
country: Japan
facility: 1218.78.036 Boehringer Ingelheim Investigational Site
city: Kasugai, Aichi
country: Japan
facility: 1218.78.026 Boehringer Ingelheim Investigational Site
city: Kawachinagano, Osaka
country: Japan
facility: 1218.78.038 Boehringer Ingelheim Investigational Site
city: Kitaazumi-gun, Nagano
country: Japan
facility: 1218.78.021 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1218.78.022 Boehringer Ingelheim Investigational Site
city: Matsumoto, Nagano
country: Japan
facility: 1218.78.033 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 1218.78.012 Boehringer Ingelheim Investigational Site
city: Meguro-ku, Tokyo
country: Japan
facility: 1218.78.041 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 1218.78.034 Boehringer Ingelheim Investigational Site
city: Morioka, Iwate
country: Japan
facility: 1218.78.035 Boehringer Ingelheim Investigational Site
city: Moriya, Ibaraki
country: Japan
facility: 1218.78.018 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.78.024 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.78.025 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.78.027 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.78.028 Boehringer Ingelheim Investigational Site
city: Nagoya, Aichi
country: Japan
facility: 1218.78.031 Boehringer Ingelheim Investigational Site
city: Oita, Oita
country: Japan
facility: 1218.78.039 Boehringer Ingelheim Investigational Site
city: Okinawa, Okinawa
country: Japan
facility: 1218.78.004 Boehringer Ingelheim Investigational Site
city: Sagae, Yamagata
country: Japan
facility: 1218.78.016 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.78.001 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.78.020 Boehringer Ingelheim Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: 1218.78.042 Boehringer Ingelheim Investigational Site
city: Shimajiri-gun, Okinawa
country: Japan
facility: 1218.78.005 Boehringer Ingelheim Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: 1218.78.014 Boehringer Ingelheim Investigational Site
city: Shinjyuku-ku. Tokyo
country: Japan
facility: 1218.78.002 Boehringer Ingelheim Investigational Site
city: Shizuoka, Shizuoka
country: Japan
facility: 1218.78.011 Boehringer Ingelheim Investigational Site
city: Suita, Osaka
country: Japan
facility: 1218.78.003 Boehringer Ingelheim Investigational Site
city: Tokorozawa, Saitama
country: Japan
facility: 1218.78.023 Boehringer Ingelheim Investigational Site
city: Tokorozawa, Saitama
country: Japan
facility: 1218.78.029 Boehringer Ingelheim Investigational Site
city: Tsuchiura, Ibaraki
country: Japan
facility: 1218.78.010 Boehringer Ingelheim Investigational Site
city: Yamagata, Yamagata
country: Japan
facility: 1218.78.015 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: