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Clinical Trial Details

Trial ID: L3626
Source ID: NCT01438814
Associated Drug: Metformin Placebo
Title: Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01438814/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: metformin placebo|DRUG: linagliptin placebo|DRUG: metformin|DRUG: metformin|DRUG: linagliptin
Outcome Measures: Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment, Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c., Baseline and 14 weeks | Secondary: Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment, The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment), 14 weeks|Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment, Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks, 14 weeks|Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment, Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose., Baseline and 14 weeks|Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment, Patients could experience multiple events, therefore, multiple answers were possible for each patient., 14 weeks|Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment, The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c., 14 weeks|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators, The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment)., 14 weeks|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment), The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment)., 14 weeks|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment), The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment)., 14 weeks|Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks, The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment)., 14 weeks|Change From Baseline in Body Weight by Visit at Week 14, Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight, Baseline and 14 weeks|Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks, The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment)., 14 weeks|Change From Baseline in HbA1c Over Time, Means are adjusted by treatment and continuous baseline HbA1c, Baseline, 2 weeks and 8 weeks
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim | Collaborators: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 689
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2011-11
Completion Date: 2013-03
Results First Posted: 2014-06-03
Last Update Posted: 2014-11-25
Locations: 1218.60.90001 Boehringer Ingelheim Investigational Site, Dhaka, Bangladesh|1218.60.90002 Boehringer Ingelheim Investigational Site, Dhaka, Bangladesh|1218.60.90003 Boehringer Ingelheim Investigational Site, Dhaka, Bangladesh|1218.60.32001 Boehringer Ingelheim Investigational Site, Genk, Belgium|1218.60.32005 Boehringer Ingelheim Investigational Site, Ham, Belgium|1218.60.32002 Boehringer Ingelheim Investigational Site, Hasselt, Belgium|1218.60.32004 Boehringer Ingelheim Investigational Site, Natoye, Belgium|1218.60.32003 Boehringer Ingelheim Investigational Site, Tremelo, Belgium|1218.60.20009 Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada|1218.60.20003 Boehringer Ingelheim Investigational Site, Burnaby, British Columbia, Canada|1218.60.20014 Boehringer Ingelheim Investigational Site, Coquitlam, British Columbia, Canada|1218.60.20010 Boehringer Ingelheim Investigational Site, Surrey, British Columbia, Canada|1218.60.20004 Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada|1218.60.20012 Boehringer Ingelheim Investigational Site, Corunna, Ontario, Canada|1218.60.20015 Boehringer Ingelheim Investigational Site, Hamilton, Ontario, Canada|1218.60.20006 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1218.60.20013 Boehringer Ingelheim Investigational Site, London, Ontario, Canada|1218.60.20002 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.60.20011 Boehringer Ingelheim Investigational Site, Sarnia, Ontario, Canada|1218.60.20005 Boehringer Ingelheim Investigational Site, Strathroy, Ontario, Canada|1218.60.20007 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.60.20016 Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada|1218.60.20001 Boehringer Ingelheim Investigational Site, St-Romuald, Quebec, Canada|1218.60.86001 Boehringer Ingelheim Investigational Site, Beijing, China|1218.60.86003 Boehringer Ingelheim Investigational Site, Beijing, China|1218.60.86011 Boehringer Ingelheim Investigational Site, Changsha, China|1218.60.86012 Boehringer Ingelheim Investigational Site, Chengdu, China|1218.60.86010 Boehringer Ingelheim Investigational Site, Chongqing, China|1218.60.86013 Boehringer Ingelheim Investigational Site, Hubei, China|1218.60.86014 Boehringer Ingelheim Investigational Site, Hubei, China|1218.60.86006 Boehringer Ingelheim Investigational Site, Nanjing, China|1218.60.86007 Boehringer Ingelheim Investigational Site, Nanjing, China|1218.60.86005 Boehringer Ingelheim Investigational Site, Shanghai, China|1218.60.86009 Boehringer Ingelheim Investigational Site, Shenyang, China|1218.60.86008 Boehringer Ingelheim Investigational Site, Wuxi, China|1218.60.49007 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.60.49008 Boehringer Ingelheim Investigational Site, Berlin, Germany|1218.60.49005 Boehringer Ingelheim Investigational Site, Dresden, Germany|1218.60.49004 Boehringer Ingelheim Investigational Site, Erfurt, Germany|1218.60.49006 Boehringer Ingelheim Investigational Site, Frankfurt, Germany|1218.60.49003 Boehringer Ingelheim Investigational Site, Hamburg, Germany|1218.60.49002 Boehringer Ingelheim Investigational Site, Neuwied, Germany|1218.60.49001 Boehringer Ingelheim Investigational Site, Unterschneidheim, Germany|1218.60.50001 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1218.60.50002 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1218.60.50003 Boehringer Ingelheim Investigational Site, Guatemala, Guatemala|1218.60.85001 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1218.60.85002 Boehringer Ingelheim Investigational Site, Hong Kong, Hong Kong|1218.60.91004 Boehringer Ingelheim Investigational Site, Aurangabad, India|1218.60.91010 Boehringer Ingelheim Investigational Site, Bangalore, India|1218.60.91005 Boehringer Ingelheim Investigational Site, Coimbatore, India|1218.60.91008 Boehringer Ingelheim Investigational Site, Kolkata, India|1218.60.91001 Boehringer Ingelheim Investigational Site, Nagpur, India|1218.60.91007 Boehringer Ingelheim Investigational Site, Nagpur, India|1218.60.91003 Boehringer Ingelheim Investigational Site, Pune, India|1218.60.91006 Boehringer Ingelheim Investigational Site, Pune, India|1218.60.96001 Boehringer Ingelheim Investigational Site, Beirut, Lebanon|1218.60.96002 Boehringer Ingelheim Investigational Site, Beirut, Lebanon|1218.60.96004 Boehringer Ingelheim Investigational Site, Byblos, Lebanon|1218.60.96003 Boehringer Ingelheim Investigational Site, Hazmieh, Lebanon|1218.60.96005 Boehringer Ingelheim Investigational Site, Saida, Lebanon|1218.60.52005 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico|1218.60.52003 Boehringer Ingelheim Investigational Site, Cuernavaca, Mexico|1218.60.52001 Boehringer Ingelheim Investigational Site, Durango, Mexico|1218.60.52002 Boehringer Ingelheim Investigational Site, Durango, Mexico|1218.60.52004 Boehringer Ingelheim Investigational Site, Monterrey, Mexico|1218.60.51001 Boehringer Ingelheim Investigational Site, Lima, Peru|1218.60.51002 Boehringer Ingelheim Investigational Site, Lima, Peru|1218.60.51004 Boehringer Ingelheim Investigational Site, Piura, Peru|1218.60.63001 Boehringer Ingelheim Investigational Site, Cebu City, Philippines, Philippines|1218.60.63004 Boehringer Ingelheim Investigational Site, Iloilo City, Philippines, Philippines|1218.60.63003 Boehringer Ingelheim Investigational Site, Manila, Philippines|1218.60.63002 Boehringer Ingelheim Investigational Site, Marikina City, Philippines, Philippines|1218.60.63005 Boehringer Ingelheim Investigational Site, Quezon City, Philippines|1218.60.34001 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.60.34002 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.60.34003 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.60.34004 Boehringer Ingelheim Investigational Site, Barcelona, Spain|1218.60.34006 Boehringer Ingelheim Investigational Site, Borges del Camp- Tarragona, Spain|1218.60.34005 Boehringer Ingelheim Investigational Site, Centelles, Spain|1218.60.34009 Boehringer Ingelheim Investigational Site, Granada, Spain|1218.60.34008 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat, Spain|1218.60.34007 Boehringer Ingelheim Investigational Site, Mataró, Spain|1218.60.34010 Boehringer Ingelheim Investigational Site, Valencia, Spain|1218.60.88006 Boehringer Ingelheim Investigational Site, Chiayi County, Taiwan|1218.60.88003 Boehringer Ingelheim Investigational Site, Kaohsiung,, Taiwan|1218.60.88001 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1218.60.88007 Boehringer Ingelheim Investigational Site, Taichung, Taiwan|1218.60.88002 Boehringer Ingelheim Investigational Site, Tainan,, Taiwan|1218.60.88004 Boehringer Ingelheim Investigational Site, Taipei County, Taiwan
URL: https://clinicaltrials.gov/show/NCT01438814

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details