Comprehensive Add on Study in Japan

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204294
• Other study ID #: 1218.78
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2010
• Last updated: February 27, 2014
• Start date: September 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Linagliptin
Linagliptin once daily
• Linagliptin
Linagliptin once daily
• Metformin
Metformin twice or three time per day
• Metformin
Metformin twice or three time per day
• Linagliptin
Linagliptin once daily
• Linagliptin
Linagliptin once daily
• Linagliptin
Linagliptin once daily

Locations

Country	Name	City	State
Japan	1218.78.008 Boehringer Ingelheim Investigational Site	Akishima, Tokyo
Japan	1218.78.030 Boehringer Ingelheim Investigational Site	Amagasaki, Hyogo
Japan	1218.78.017 Boehringer Ingelheim Investigational Site	Annaka, Gunma
Japan	1218.78.006 Boehringer Ingelheim Investigational Site	Aomori, Aomori
Japan	1218.78.007 Boehringer Ingelheim Investigational Site	Aomori, Aomori
Japan	1218.78.009 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1218.78.013 Boehringer Ingelheim Investigational Site	Chuo-ku, Tokyo
Japan	1218.78.032 Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	1218.78.040 Boehringer Ingelheim Investigational Site	Fukuoka, Fukuoka
Japan	1218.78.037 Boehringer Ingelheim Investigational Site	Higashi Osaka, Osaka
Japan	1218.78.043 Boehringer Ingelheim Investigational Site	Hitachinaka, Ibaraki
Japan	1218.78.019 Boehringer Ingelheim Investigational Site	Isesaki, Gunma
Japan	1218.78.036 Boehringer Ingelheim Investigational Site	Kashiwara, Osaka
Japan	1218.78.026 Boehringer Ingelheim Investigational Site	Kasugai, Aichi
Japan	1218.78.038 Boehringer Ingelheim Investigational Site	Kawachinagano, Osaka
Japan	1218.78.021 Boehringer Ingelheim Investigational Site	Kitaazumi-gun, Nagano
Japan	1218.78.022 Boehringer Ingelheim Investigational Site	Matsumoto, Nagano
Japan	1218.78.033 Boehringer Ingelheim Investigational Site	Matsumoto, Nagano
Japan	1218.78.012 Boehringer Ingelheim Investigational Site	Meguro-ku, Tokyo
Japan	1218.78.041 Boehringer Ingelheim Investigational Site	Meguro-ku, Tokyo
Japan	1218.78.034 Boehringer Ingelheim Investigational Site	Morioka, Iwate
Japan	1218.78.035 Boehringer Ingelheim Investigational Site	Morioka, Iwate
Japan	1218.78.018 Boehringer Ingelheim Investigational Site	Moriya, Ibaraki
Japan	1218.78.024 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.78.025 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.78.027 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.78.028 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.78.031 Boehringer Ingelheim Investigational Site	Nagoya, Aichi
Japan	1218.78.039 Boehringer Ingelheim Investigational Site	Oita, Oita
Japan	1218.78.004 Boehringer Ingelheim Investigational Site	Okinawa, Okinawa
Japan	1218.78.016 Boehringer Ingelheim Investigational Site	Sagae, Yamagata
Japan	1218.78.001 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.78.020 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.78.042 Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	1218.78.005 Boehringer Ingelheim Investigational Site	Shimajiri-gun, Okinawa
Japan	1218.78.014 Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo
Japan	1218.78.002 Boehringer Ingelheim Investigational Site	Shinjyuku-ku. Tokyo
Japan	1218.78.011 Boehringer Ingelheim Investigational Site	Shizuoka, Shizuoka
Japan	1218.78.003 Boehringer Ingelheim Investigational Site	Suita, Osaka
Japan	1218.78.023 Boehringer Ingelheim Investigational Site	Tokorozawa, Saitama
Japan	1218.78.029 Boehringer Ingelheim Investigational Site	Tokorozawa, Saitama
Japan	1218.78.010 Boehringer Ingelheim Investigational Site	Tsuchiura, Ibaraki
Japan	1218.78.015 Boehringer Ingelheim Investigational Site	Yamagata, Yamagata

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events	The first drug administration through 7 days after the last drug administration, up to 382 days	Yes
Secondary	Glycosylated Haemoglobin A1c (HbA1c)	The change from baseline in HbA1c after 52 weeks of treatment. When the HbA1c after 52 weeks treatment was missing, the value from the measurements at the closest preceding visit replaced the missing value.	Baseline and 52 weeks	No

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