Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Overview[ - collapse ][ - ]
Purpose | This phase IV, randomized, double-blind, double-dummy, active-comparator controlled study is to compare the efficacy and safety of linagliptin (5mg) co-administered with metformin (QD, metformin daily dose 1000mg)at evening time with metformin BID (min daily dose 1000mg, max.daily dose 2000mg) over 14 weeks in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: metformin placebo Drug: linagliptin placebo Drug: metformin Drug: placebo metformin Drug: metformin Drug: linagliptin |
Phase | Phase 4 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT01438814 |
First Received | September 21, 2011 |
Last Updated | July 24, 2013 |
Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 21, 2011 |
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Last Updated Date | July 24, 2013 |
Start Date | November 2011 |
Estimated Primary Completion Date | March 2013 |
Current Primary Outcome Measures | The change from baseline in Glycosylated Hemoglobin A1c (HbA1c) after 14 weeks treatment [Time Frame: 14 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control |
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Official Title | A Randomised, Double-blind, Double-dummy, Active-comparator Controlled Study Investigating the Efficacy and Safety of Linagliptin Co-administered With Metformin QD at Evening Time Versus Metformin BID Over 14 Weeks in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control |
Brief Summary | This phase IV, randomized, double-blind, double-dummy, active-comparator controlled study is to compare the efficacy and safety of linagliptin (5mg) co-administered with metformin (QD, metformin daily dose 1000mg)at evening time with metformin BID (min daily dose 1000mg, max.daily dose 2000mg) over 14 weeks in treatment naive patients with type 2 diabetes mellitus and insufficient glycaemic control. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: metformin placebo metformin placebo tablets 500mg Drug: linagliptin placebo linagliptin placebo tablets 5mg Drug: metformin metformin tablets 500mg Drug: placebo metformin placebo metformin 500 mg Drug: metformin metformin tablets 500 mg Drug: linagliptin linaglitpin tablets 5mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 689 |
Estimated Completion Date | March 2013 |
Estimated Primary Completion Date | March 2013 |
Eligibility Criteria | Inclusion criteria: 1. Diagnosis of Type 2 diabetes mellitus (T2DM) prior to informed consent; 2. Male and female patients on diet and exercise regimen who are drug naive, defined as absence of any oral antidiabetic therapy or insulin for 12 weeks prior to randomization 3. Glycosylated haemoglobin A1c (HbA1c) >/= 7.0% (53 mmol/mol) to = 10.0% (86 mmol/mol)at visit 1 (screening); 4. Age>/=18 and =80 years at visit 1(screening); 5. Body Mass Index(BMI)= 45kg/m2 at vist 1 (screening); 6. Signed and dated written informed consent by date of visit 1 in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (13.3mmol/L) after an overnight fast during screening/placebo run-in and confirmed by a second measurement (Not on the same day); 2. Treatment with any oral antidiabetic drug or insulin within 12 weeks prior to randomization 3. Myocardial infarction,stroke or Transient ischemia attack (TIA) within 3 months prior to informed consent; 4. Indication of liver disease/Impaired hepatic function, defined by serum levels of either Aspartate aminotransferase (ALT or SGPT), alanine aminotransferase (AST or SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at visit 1, 5. Impaired renal function, defined as eGFR< 60ml/min (severe renal impairment, modification of diet in renal disease (MDRD) formula) as determined at run-in phase 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induced chronic malabsorption 7. Medical history of Cancer(except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Blood dyscrasia or any other disorders causing haemolysis or unstable Red Blood Cell (eg. malaria, babesiosis, haemolytic anemia) 9. Known history of pancreatitis and chronic pancreatitis 10. Contraindications to metformin according to the local label 11. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen etc) leading to unstable body weight 12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM 13. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who: 1. are nursing or pregnant or 2. are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial or who do not agree to continue contraception for at least 30 days after the last dose of study drug. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. 14. Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drgu intake 15. Participation in another trial with application of any investigational drug within 30 days prior to informed consent 16. Any other clinical condition that would jeopardize patients safety while participating in this trial |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Bangladesh, Belgium, Canada, China, Germany, Guatemala, Hong Kong, India, Lebanon, Mexico, Peru, Philippines, Spain, Taiwan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01438814 |
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Other Study ID Numbers | 1218.60 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Eli Lilly and Company |
Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
Verification Date | July 2013 |
Locations[ + expand ][ + ]
1218.60.90001 Boehringer Ingelheim Investigational Site | Dhaka, Bangladesh |
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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 |
1218.60.20013 Boehringer Ingelheim Investigational Site | London, Ontario, Canada |
1218.60.20006 Boehringer Ingelheim Investigational Site | London, Ontario, Canada |
1218.60.20011 Boehringer Ingelheim Investigational Site | Sarnia, Ontario, Canada |
1218.60.20002 Boehringer Ingelheim Investigational Site | Sarnia, Ontario, Canada |
1218.60.20005 Boehringer Ingelheim Investigational Site | Strathroy, Ontario, Canada |
1218.60.20016 Boehringer Ingelheim Investigational Site | Toronto, Ontario, Canada |
1218.60.20007 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 |
1218.60.86014 Boehringer Ingelheim Investigational Site | Hubei, China |
1218.60.86013 Boehringer Ingelheim Investigational Site | Hubei, China |
1218.60.86007 Boehringer Ingelheim Investigational Site | Nanjing, China |
1218.60.86006 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 |
1218.60.50002 Boehringer Ingelheim Investigational Site | Guatemala, Guatemala |
1218.60.50001 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 |
1218.60.91006 Boehringer Ingelheim Investigational Site | Pune, India |
1218.60.91003 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 |
1218.60.51002 Boehringer Ingelheim Investigational Site | Lima, Peru |
1218.60.51001 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 |
1218.60.88007 Boehringer Ingelheim Investigational Site | Taichung, Taiwan |
1218.60.88001 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 |