Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients
Overview[ - collapse ][ - ]
Purpose | The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Placebo Drug: BI 1356 dose 3 once daily Drug: BI 1356 dose 2 once daily Drug: BI 1356 dose 1 once daily Drug: Metformin |
Phase | Phase 2 |
Sponsor | Boehringer Ingelheim |
Responsible Party | Boehringer Ingelheim |
ClinicalTrials.gov Identifier | NCT00328172 |
First Received | May 18, 2006 |
Last Updated | February 15, 2014 |
Last verified | February 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | May 18, 2006 |
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Last Updated Date | February 15, 2014 |
Start Date | May 2006 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12 [Time Frame: Baseline, week 12] [Designated as safety issue: No]The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients |
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Official Title | A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm) |
Brief Summary | The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
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: Placebo Placebo matching BI 1356 Drug: BI 1356 dose 3 once daily BI 1356 dose 3 once daily Drug: BI 1356 dose 2 once daily BI 1356 dose 2 once daily Drug: BI 1356 dose 1 once daily BI 1356 dose 1 once daily Drug: Metformin Metformin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 302 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | August 2007 |
Eligibility Criteria | Inclusion criteria: 1. Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening. 2. Diagnosis of Type 2 diabetes with duration of at least 3 months 3. Glycosylated haemoglobin A1 (HbA1c) of: 7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required) 4. HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period). 5. Age >=21 and <=75 years. 6. BMI (Body Mass Index) >=25.0 and <=40 kg/m2. 7. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation Exclusion criteria: 1. Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment) 2. Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal 3. Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial 5. Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis) 6. History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients) 7. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening 8. Treatment with insulin within 3 months prior to screening 9. Alcohol or drug abuse within the last 3 months that would interfere with trial participation) 10. Participation in another trial with an investigational drug within two months prior to administration or during the trial 11. Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day) 12. Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: 1. are not surgically sterile, 2. or are nursing or pregnant; 3. or 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. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made. 13. Intolerance of metformin |
Gender | Both |
Ages | 21 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Canada, Czech Republic, Russian Federation, Ukraine |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00328172 |
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Other Study ID Numbers | 1218.5 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Boehringer Ingelheim |
Study Sponsor | Boehringer Ingelheim |
Collaborators | Not Provided |
Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
Verification Date | February 2014 |
Locations[ + expand ][ + ]
1218.5.10020 Boehringer Ingelheim Investigational Site | Chula Vista, California, United States |
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1218.5.10001 Boehringer Ingelheim Investigational Site | La Jolla, California, United States |
1218.5.10007 Boehringer Ingelheim Investigational Site | Walnut Creek, California, United States |
1218.5.10041 Boehringer Ingelheim Investigational Site | Denver, Colorado, United States |
1218.5.10018 Boehringer Ingelheim Investigational Site | Hollywood, Florida, United States |
1218.5.10016 Boehringer Ingelheim Investigational Site | Jacksonville, Florida, United States |
1218.5.10011 Boehringer Ingelheim Investigational Site | Miami, Florida, United States |
1218.5.10003 Boehringer Ingelheim Investigational Site | Miami, Florida, United States |
1218.5.10012 Boehringer Ingelheim Investigational Site | Orlando, Florida, United States |
1218.5.10017 Boehringer Ingelheim Investigational Site | Indianapolis, Indiana, United States |
1218.5.10008 Boehringer Ingelheim Investigational Site | Topeka, Kansas, United States |
1218.5.10024 Boehringer Ingelheim Investigational Site | Wichita, Kansas, United States |
1218.5.10039 Boehringer Ingelheim Investigational Site | Baltimore, Maryland, United States |
1218.5.10032 Boehringer Ingelheim Investigational Site | Springfield, Massachusetts, United States |
1218.5.10025 Boehringer Ingelheim Investigational Site | Chesterfield, Missouri, United States |
1218.5.10034 Boehringer Ingelheim Investigational Site | Butte, Montana, United States |
1218.5.10009 Boehringer Ingelheim Investigational Site | Omaha, Nebraska, United States |
1218.5.10042 Boehringer Ingelheim Investigational Site | Albany, New York, United States |
1218.5.10029 Boehringer Ingelheim Investigational Site | Endwell, New York, United States |
1218.5.10004 Boehringer Ingelheim Investigational Site | New Hyde Park, New York, United States |
1218.5.10026 Boehringer Ingelheim Investigational Site | Columbus, Ohio, United States |
1218.5.10035 Boehringer Ingelheim Investigational Site | Mentor, Ohio, United States |
1218.5.10023 Boehringer Ingelheim Investigational Site | Medford, Oregon, United States |
1218.5.10030 Boehringer Ingelheim Investigational Site | Philadelphia, Pennsylvania, United States |
1218.5.10044 Boehringer Ingelheim Investigational Site | Columbia, South Carolina, United States |
1218.5.10033 Boehringer Ingelheim Investigational Site | Greer, South Carolina, United States |
1218.5.10038 Boehringer Ingelheim Investigational Site | Simpsonville, South Carolina, United States |
1218.5.10006 Boehringer Ingelheim Investigational Site | Dallas, Texas, United States |
1218.5.10040 Boehringer Ingelheim Investigational Site | Houston, Texas, United States |
1218.5.10036 Boehringer Ingelheim Investigational Site | San Antonio, Texas, United States |
1218.5.10021 Boehringer Ingelheim Investigational Site | Tyler, Texas, United States |
1218.5.10027 Boehringer Ingelheim Investigational Site | Salem, Virginia, United States |
1218.5.10022 Boehringer Ingelheim Investigational Site | Federal Way, Washington, United States |
1218.5.10014 Boehringer Ingelheim Investigational Site | Renton, Washington, United States |
1218.5.61001 Boehringer Ingelheim Investigational Site | Miranda, New South Wales, Australia |
1218.5.61005 Boehringer Ingelheim Investigational Site | Box Hill, Victoria, Australia |
1218.5.61006 Boehringer Ingelheim Investigational Site | Dandenong, Victoria, Australia |
1218.5.61007 Boehringer Ingelheim Investigational Site | East Ringwood, Victoria, Australia |
1218.5.61004 Boehringer Ingelheim Investigational Site | Fremantle, Western Australia, Australia |
1218.5.61002 Boehringer Ingelheim Investigational Site | Nedlands, Western Australia, Australia |
1218.5.11016 Boehringer Ingelheim Investigational Site | Calgary, Alberta, Canada |
1218.5.11011 Boehringer Ingelheim Investigational Site | Calgary, Alberta, Canada |
1218.5.11003 Boehringer Ingelheim Investigational Site | Red Deer, Alberta, Canada |
1218.5.11013 Boehringer Ingelheim Investigational Site | Vancouver, British Columbia, Canada |
1218.5.11004 Boehringer Ingelheim Investigational Site | Vancouver, British Columbia, Canada |
1218.5.11015 Boehringer Ingelheim Investigational Site | Winnipeg, Manitoba, Canada |
1218.5.11005 Boehringer Ingelheim Investigational Site | Hamilton, Ontario, Canada |
1218.5.11014 Boehringer Ingelheim Investigational Site | Oakville, Ontario, Canada |
1218.5.11010 Boehringer Ingelheim Investigational Site | Ottawa, Ontario, Canada |
1218.5.11009 Boehringer Ingelheim Investigational Site | Sarnia, Ontario, Canada |
1218.5.11012 Boehringer Ingelheim Investigational Site | Thornhill, Ontario, Canada |
1218.5.11002 Boehringer Ingelheim Investigational Site | Toronto, Ontario, Canada |
1218.5.11006 Boehringer Ingelheim Investigational Site | Montague, Prince Edward Island, Canada |
1218.5.11017 Boehringer Ingelheim Investigational Site | Sainte-Foy, Quebec, Canada |
1218.5.11018 Boehringer Ingelheim Investigational Site | Saskatoon, Saskatchewan, Canada |
1218.5.42002 Boehringer Ingelheim Investigational Site | Olomouc 9, Czech Republic |
1218.5.42005 Boehringer Ingelheim Investigational Site | Praha 4, Czech Republic |
1218.5.42003 Boehringer Ingelheim Investigational Site | Praha 4, Czech Republic |
1218.5.42004 Boehringer Ingelheim Investigational Site | Praha 9, Czech Republic |
1218.5.42001 Boehringer Ingelheim Investigational Site | Sternberk, Czech Republic |
1218.5.70002 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1218.5.70003 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1218.5.70001 Boehringer Ingelheim Investigational Site | Moscow, Russian Federation |
1218.5.70004 Boehringer Ingelheim Investigational Site | St. Petersburg, Russian Federation |
1218.5.70005 Boehringer Ingelheim Investigational Site | St. Petersburg, Russian Federation |
1218.5.38005 Boehringer Ingelheim Investigational Site | Kharkov, Ukraine |
1218.5.38001 Boehringer Ingelheim Investigational Site | Kiev, Ukraine |
1218.5.38003 Boehringer Ingelheim Investigational Site | Kiev, Ukraine |
1218.5.38002 Boehringer Ingelheim Investigational Site | Kiev, Ukraine |
1218.5.38004 Boehringer Ingelheim Investigational Site | Lvov, Ukraine |
1218.5.38006 Boehringer Ingelheim Investigational Site | Vinnitsa, Ukraine |