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)

1218.78.008 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

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