Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Terminated

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

• Registration Number: NCT01826370
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-08
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-09
• Results First Submitted: 2014-09-10
• Results First Submitted QC: 2014-09-17
• Last Update Submitted: 2014-09-17
• Results First Posted: 2014-09-18
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Linagliptin	Linagliptin	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events and Serious Adverse Events	Week 24	Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 24 of HbA1c	Baseline and 24 weeks	Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)
Change From Baseline to Week 24 of Fasting Blood Sugar	Baseline and 24 weeks	Change from baseline to week 24 of fasting blood sugar

Trial Locations

Locations (51)

Boehringer Ingelheim Investigational Site 43; 🇵🇭 Agoo, La Union, Philippines

Boehringer Ingelheim Investigational Site 40; 🇵🇭 Angeles City, Pampanga, Philippines

Boehringer Ingelheim Investigational Site 31; 🇵🇭 Angono, Rizal, Philippines

Boehringer Ingelheim Investigational Site 32; 🇵🇭 Antipolo, Rizal, Philippines

Boehringer Ingelheim Investigational Site 27; 🇵🇭 Aparri, Cagayan, Philippines

Boehringer Ingelheim Investigational Site 4; 🇵🇭 Batangas, Philippines

Boehringer Ingelheim Investigational Site 48; 🇵🇭 Butuan City, Agusan del Norte, Philippines

Boehringer Ingelheim Investigational Site 12; 🇵🇭 Cabanatuan, Nueva Ecija, Philippines

Boehringer Ingelheim Investigational Site 23; 🇵🇭 Cagayan de Oro, Philippines

Boehringer Ingelheim Investigational Site 3; 🇵🇭 Caloocan, Philippines

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