Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Trial of BI 10773 (10 and 25 mg Administered Orally Once Daily) Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite a Background Therapy of Pioglitazone Alone or in Combination With Metformin
This study will investigate the efficacy and safety of BI 10773 in type 2 diabetic patients in order to provide these data for approval for BI 10773 by regulatory authorities as an antidiabetic agent as add-on therapy to pioglitazone alone or in combination with metformin.
| Status | Completed |
| Enrollment | 499 |
| Est. completion date | |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent. 2. Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation. 3. HbA1c of >/= 7.0% and </= 10.0% at Visit 1 (screening). 4. Age >/= 18. 5. BMI </= 45 kg/m2 (Body Mass Index) at Visit 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 (> 13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. Any other antidiabetic medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2. 3. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent. 4. Indication of liver disease, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3). 5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) < 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease] formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3). 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption. 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years . 8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia). 9. Contraindications to pioglitazone according to the local label. 10. Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels. 11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 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 T2D. 13. Pre-menopausal women (last menstruation </= 1 year prior to informed consent) who: - are nursing or pregnant 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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable to local authorities), double barrier method and vasectomised partner. 14. Alcohol or drug abuse within the 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 drug intake. 15. Participation in another trial with an investigational drug within 30 days prior to informed consent. 16. Any other clinical condition that would jeopardise patient safety while participating in this clinical trial. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | 1245.19.20057 Boehringer Ingelheim Investigational Site | Brampton | Ontario |
| Canada | 1245.19.20059 Boehringer Ingelheim Investigational Site | Fort Erie | Ontario |
| Canada | 1245.19.20060 Boehringer Ingelheim Investigational Site | London | Ontario |
| Canada | 1245.19.20012 G.A. Research Associates Ltd. | Moncton | New Brunswick |
| Canada | 1245.19.20009 Boehringer Ingelheim Investigational Site | Newmarket | Ontario |
| Canada | 1245.19.20034 Boehringer Ingelheim Investigational Site | Sarnia | Ontario |
| Canada | 1245.19.20041 Boehringer Ingelheim Investigational Site | Saskatoon | Saskatchewan |
| Canada | 1245.19.20058 Boehringer Ingelheim Investigational Site | St-Romuald | Quebec |
| Canada | 1245.19.20031 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | 1245.19.20047 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Canada | 1245.19.20062 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Greece | 1245.19.30002 Boehringer Ingelheim Investigational Site | Athens | |
| Greece | 1245.19.30001 Boehringer Ingelheim Investigational Site | Nikaia | |
| Greece | 1245.19.30004 Boehringer Ingelheim Investigational Site | Thessaloniki | |
| India | 1245.19.91005 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1245.19.91006 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1245.19.91008 Boehringer Ingelheim Investigational Site | Bangalore | |
| India | 1245.19.91003 Boehringer Ingelheim Investigational Site | Belgaum | |
| India | 1245.19.91004 Boehringer Ingelheim Investigational Site | Chennai | |
| India | 1245.19.91009 Boehringer Ingelheim Investigational Site | Chennai | |
| India | 1245.19.91001 Boehringer Ingelheim Investigational Site | Coimbatore | |
| India | 1245.19.91015 Boehringer Ingelheim Investigational Site | Gulbarga | |
| India | 1245.19.91011 Boehringer Ingelheim Investigational Site | Kartanaka | |
| India | 1245.19.91002 Boehringer Ingelheim Investigational Site | Mumbai | |
| India | 1245.19.91007 Boehringer Ingelheim Investigational Site | Mumbai, Maharastra | |
| India | 1245.19.91017 Boehringer Ingelheim Investigational Site | Mysore | |
| India | 1245.19.91010 Boehringer Ingelheim Investigational Site | Nagpur | |
| India | 1245.19.91012 Boehringer Ingelheim Investigational Site | New Delhi | |
| India | 1245.19.91013 Boehringer Ingelheim Investigational Site | Patna | |
| India | 1245.19.91014 Boehringer Ingelheim Investigational Site | Pune | |
| India | 1245.19.91016 Boehringer Ingelheim Investigational Site | Pune | |
| Philippines | 1245.19.63002 Boehringer Ingelheim Investigational Site | Cebu City, N/A, Philippines | |
| Philippines | 1245.19.63003 Boehringer Ingelheim Investigational Site | Davao City, N/A, Philippines | |
| Philippines | 1245.19.63004 Boehringer Ingelheim Investigational Site | Manila, Philippines | |
| Philippines | 1245.19.63005 Boehringer Ingelheim Investigational Site | Pasig City, Philippines | |
| Philippines | 1245.19.63001 Boehringer Ingelheim Investigational Site | San Juan City, Philippines | |
| Thailand | 1245.19.66003 Boehringer Ingelheim Investigational Site | Saimai | |
| Thailand | 1245.19.66004 Boehringer Ingelheim Investigational Site | Udon Thani, Thailand | |
| Ukraine | 1245.19.75002 Boehringer Ingelheim Investigational Site | Dnepropetrovsk | |
| Ukraine | 1245.19.75001 Boehringer Ingelheim Investigational Site | Kharkov | |
| Ukraine | 1245.19.75005 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1245.19.75006 Boehringer Ingelheim Investigational Site | Lviv | |
| Ukraine | 1245.19.75004 Boehringer Ingelheim Investigational Site | Vinnitsa | |
| Ukraine | 1245.19.75003 Boehringer Ingelheim Investigational Site | Vinnytsya | |
| United States | 1245.19.10071 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina |
| United States | 1245.19.10033 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee |
| United States | 1245.19.10003 Boehringer Ingelheim Investigational Site | Dearborn | Michigan |
| United States | 1245.19.10014 Boehringer Ingelheim Investigational Site | Dubuque | Iowa |
| United States | 1245.19.10160 Boehringer Ingelheim Investigational Site | Essex | Maryland |
| United States | 1245.19.10162 Boehringer Ingelheim Investigational Site | Glendale | Arizona |
| United States | 1245.19.10070 Boehringer Ingelheim Investigational Site | Irvine | California |
| United States | 1245.19.10133 Boehringer Ingelheim Investigational Site | Jupiter | Florida |
| United States | 1245.19.10047 Boehringer Ingelheim Investigational Site | La Mesa | California |
| United States | 1245.19.10008 Boehringer Ingelheim Investigational Site | Marion | Ohio |
| United States | 1245.19.10112 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1245.19.10141 Boehringer Ingelheim Investigational Site | Milford | Connecticut |
| United States | 1245.19.10056 Boehringer Ingelheim Investigational Site | Muscle Shoals | Alabama |
| United States | 1245.19.10059 Boehringer Ingelheim Investigational Site | New Hyde Park | New York |
| United States | 1245.19.10002 Boehringer Ingelheim Investigational Site | Norfolk | Virginia |
| United States | 1245.19.10077 Boehringer Ingelheim Investigational Site | Perry | Georgia |
| United States | 1245.19.10161 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | 1245.19.10085 Boehringer Ingelheim Investigational Site | Plantation | Florida |
| United States | 1245.19.10149 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California |
| United States | 1245.19.10163 Boehringer Ingelheim Investigational Site | Riverside | California |
| United States | 1245.19.10086 Boehringer Ingelheim Investigational Site | Salisbury | North Carolina |
| United States | 1245.19.10123 Boehringer Ingelheim Investigational Site | Smithtown | New York |
| United States | 1245.19.10046 Boehringer Ingelheim Investigational Site | Tempe | Arizona |
| United States | 1245.19.10131 Boehringer Ingelheim Investigational Site | West Hills | California |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States, Canada, Greece, India, Philippines, Thailand, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Hypoglycaemic Events | Number of patients with hypoglycaemic events, as reported as adverse events. | From first drug administration until 7 days after last intake of study drug, up to 256 days | No |
| Primary | HbA1c Change From Baseline | Change From Baseline in HbA1c after 24 weeks. Note that adjusted means are provided. |
Baseline and 24 weeks | No |
| Primary | HbA1c Change From Baseline for Pio and Met Background Medication Patients | Change From Baseline in HbA1c after 24 weeks for patients with pioglitazone (pio) and metformin (met) background medication only. Note that adjusted means are provided. |
Baseline and 24 weeks | No |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline | Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Note that adjusted means are provided. |
Baseline and 24 weeks | No |
| Secondary | Body Weight Change From Baseline | Change from baseline in body weight after 24 weeks. Note that adjusted means are provided. |
Baseline and 24 weeks | No |
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