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 42; 🇵🇭 Cardona, Rizal, Philippines

Boehringer Ingelheim Investigational Site 24; 🇵🇭 Las Pinas, Philippines

Boehringer Ingelheim Investigational Site 25; 🇵🇭 Cebu, Philippines

Boehringer Ingelheim Investigational Site 11; 🇵🇭 Rosales, Pangasinan, Philippines

Boehringer Ingelheim Investigational Site 13; 🇵🇭 San Jose, Nueva Ecija, Philippines

Boehringer Ingelheim Investigational Site 22; 🇵🇭 Zamboanga, Philippines

Boehringer Ingelheim Investigational Site 14; 🇵🇭 Tuguegarao, Cagayan, Philippines

Boehringer Ingelheim Investigational Site 45; 🇵🇭 Iriga City, Camarines Sur, Philippines

Boehringer Ingelheim Investigational Site 1; 🇵🇭 Makati, Philippines

Boehringer Ingelheim Investigational Site 28; 🇵🇭 Manila, Philippines

Boehringer Ingelheim Investigational Site 5; 🇵🇭 Marikina, Philippines

Boehringer Ingelheim Investigational Site 47; 🇵🇭 Naga City, Camarines Sur, Philippines

Boehringer Ingelheim Investigational Site 38; 🇵🇭 Sta.Maria, Bulacan, Philippines

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 4; 🇵🇭 Batangas, Philippines

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

Boehringer Ingelheim Investigational Site 3; 🇵🇭 Caloocan, Philippines

Boehringer Ingelheim Investigational Site 2; 🇵🇭 Iloilo, Philippines

Boehringer Ingelheim Investigational Site 35; 🇵🇭 Lucena, Quezon, Philippines

Boehringer Ingelheim Investigational Site 30; 🇵🇭 Pasig, Philippines

Boehringer Ingelheim Investigational Site 29; 🇵🇭 San Juan, Philippines

Boehringer Ingelheim Investigational Site 41; 🇵🇭 Santiago city, Isabela, Philippines

Boehringer Ingelheim Investigational Site 17; 🇵🇭 Valenzuela, Bulacan, Philippines

Boehringer Ingelheim Investigational Site 46; 🇵🇭 Valencia City Bukidnon, Philippines

Boehringer Ingelheim Investigational Site 44; 🇵🇭 Dagupan, Pangasinan, Philippines

Boehringer Ingelheim Investigational Site 7; 🇵🇭 Legazpi, Albay, Philippines

Boehringer Ingelheim Investigational Site 16; 🇵🇭 Meycauyan, Bulacan, Philippines

Boehringer Ingelheim Investigational Site 51; 🇵🇭 Pasay City, Philippines

Boehringer Ingelheim Investigational Site 34; 🇵🇭 Puerto Princesa, Palawan, Philippines

Boehringer Ingelheim Investigational Site 9; 🇵🇭 San Fernando, Pampanga, Philippines

Boehringer Ingelheim Investigational Site 50; 🇵🇭 San Pedro, Laguna, Philippines

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

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

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

Boehringer Ingelheim Investigational Site 49; 🇵🇭 Iligan City, Lanao del Norte, Philippines

Boehringer Ingelheim Investigational Site 20; 🇵🇭 Laoag, Ilocos Norte, Philippines

Boehringer Ingelheim Investigational Site 19; 🇵🇭 Paranaque, Philippines

Boehringer Ingelheim Investigational Site 33; 🇵🇭 Tagbilaran, Bohol, Philippines

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

Boehringer Ingelheim Investigational Site 39; 🇵🇭 Malolos, Bulacan, Philippines

Boehringer Ingelheim Investigational Site 37; 🇵🇭 Mandaluyong City, Philippines

Boehringer Ingelheim Investigational Site 15; 🇵🇭 Olongapo, Philippines

Boehringer Ingelheim Investigational Site 21; 🇵🇭 San Fernando, La Union, Philippines

Boehringer Ingelheim Investigational Site 8; 🇵🇭 San Pablo, Laguna, Philippines

Boehringer Ingelheim Investigational Site 6; 🇵🇭 Tacloban, Philippines

Boehringer Ingelheim Investigational Site 10; 🇵🇭 Pampanga, Philippines

Boehringer Ingelheim Investigational Site 26; 🇵🇭 Quezon City, Philippines

Boehringer Ingelheim Investigational Site 36; 🇵🇭 Sogod, Southern Leyte, Philippines

Boehringer Ingelheim Investigational Site 18; 🇵🇭 Urdaneta, Pangasinan, Philippines