Comprehensive Add on Study in Japan

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Linagliptin; Drug: Metformin

• Registration Number: NCT01204294
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-16
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2012-12-18
• Results First Submitted QC: 2012-12-18
• Results First Posted: 2013-01-23
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 574

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A-GI+Lina	Linagliptin	alpha-glucosidase inhibitor plus linagliptin
SU+Met	Metformin	sulfonylurea plus metformin
Glit+Lina	Linagliptin	glitazone plus linagliptin
Bigu+Lina	Linagliptin	biguanide plus linagliptin
Glin+Lina	Linagliptin	glinide plus linagliptin
SU+Lina	Linagliptin	sulfonylurea plus linagliptin
A-GI+Met	Metformin	alpha-glucosidase inhibitor plus metformin

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	The first drug administration through 7 days after the last drug administration, up to 382 days	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

Secondary Outcome Measures

Name	Time	Method
Glycosylated Haemoglobin A1c (HbA1c)	Baseline and 52 weeks	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.

Trial Locations

Locations (43)

1218.78.037 Boehringer Ingelheim Investigational Site; 🇯🇵 Higashi Osaka, Osaka, Japan

1218.78.026 Boehringer Ingelheim Investigational Site; 🇯🇵 Kasugai, Aichi, Japan

1218.78.038 Boehringer Ingelheim Investigational Site; 🇯🇵 Kawachinagano, Osaka, Japan

1218.78.034 Boehringer Ingelheim Investigational Site; 🇯🇵 Morioka, Iwate, Japan

1218.78.021 Boehringer Ingelheim Investigational Site; 🇯🇵 Kitaazumi-gun, Nagano, Japan

1218.78.019 Boehringer Ingelheim Investigational Site; 🇯🇵 Isesaki, Gunma, Japan

1218.78.036 Boehringer Ingelheim Investigational Site; 🇯🇵 Kashiwara, Osaka, Japan

1218.78.041 Boehringer Ingelheim Investigational Site; 🇯🇵 Meguro-ku, Tokyo, Japan

1218.78.022 Boehringer Ingelheim Investigational Site; 🇯🇵 Matsumoto, Nagano, Japan

1218.78.035 Boehringer Ingelheim Investigational Site; 🇯🇵 Morioka, Iwate, Japan

1218.78.020 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.78.013 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1218.78.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Aomori, Aomori, Japan

1218.78.040 Boehringer Ingelheim Investigational Site; 🇯🇵 Fukuoka, Fukuoka, Japan

1218.78.008 Boehringer Ingelheim Investigational Site; 🇯🇵 Akishima, Tokyo, Japan

1218.78.030 Boehringer Ingelheim Investigational Site; 🇯🇵 Amagasaki, Hyogo, Japan

1218.78.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Aomori, Aomori, Japan

1218.78.032 Boehringer Ingelheim Investigational Site; 🇯🇵 Fukuoka, Fukuoka, Japan

1218.78.018 Boehringer Ingelheim Investigational Site; 🇯🇵 Moriya, Ibaraki, Japan

1218.78.027 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.78.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjyuku-ku. Tokyo, Japan

1218.78.010 Boehringer Ingelheim Investigational Site; 🇯🇵 Tsuchiura, Ibaraki, Japan

1218.78.024 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.78.028 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.78.014 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1218.78.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1218.78.029 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokorozawa, Saitama, Japan

1218.78.015 Boehringer Ingelheim Investigational Site; 🇯🇵 Yamagata, Yamagata, Japan

1218.78.011 Boehringer Ingelheim Investigational Site; 🇯🇵 Shizuoka, Shizuoka, Japan

1218.78.009 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1218.78.017 Boehringer Ingelheim Investigational Site; 🇯🇵 Annaka, Gunma, Japan

1218.78.043 Boehringer Ingelheim Investigational Site; 🇯🇵 Hitachinaka, Ibaraki, Japan

1218.78.012 Boehringer Ingelheim Investigational Site; 🇯🇵 Meguro-ku, Tokyo, Japan

1218.78.033 Boehringer Ingelheim Investigational Site; 🇯🇵 Matsumoto, Nagano, Japan

1218.78.025 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.78.039 Boehringer Ingelheim Investigational Site; 🇯🇵 Oita, Oita, Japan

1218.78.031 Boehringer Ingelheim Investigational Site; 🇯🇵 Nagoya, Aichi, Japan

1218.78.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Okinawa, Okinawa, Japan

1218.78.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.78.016 Boehringer Ingelheim Investigational Site; 🇯🇵 Sagae, Yamagata, Japan

1218.78.042 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1218.78.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Shimajiri-gun, Okinawa, Japan

1218.78.023 Boehringer Ingelheim Investigational Site; 🇯🇵 Tokorozawa, Saitama, Japan