Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea
The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
| Status | Completed |
| Enrollment | 1504 |
| Est. completion date | |
| Est. primary completion date | February 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 a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation. Minimum dose for metformin: > or = 1500 mg/day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: > or = half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label 3. HbA1c of > or = 7.0% and < or = 11% at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of > 11% at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773) 4. Age> or = 18 5. Body Mass Index (BM)I < or = 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 drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2 3. Myocardial infarction, stroke or transient ischemic attack (TIA) within 3 months prior to informed consent 4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase 5. Impaired renal function, defined as eGFR<30 ml/min (severe renal impairment) as determined during screening and/or run-in phase 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. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy 9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia) 10. 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 11. 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 Typ 2 Diabetes 12. 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 study 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 by local authorities), double barrier method and vasectomised partner 13. 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 14. Participation in another trial with an investigational drug within 30 days prior to informed consent 15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | 1245.23.20001 Boehringer Ingelheim Investigational Site | Barrie | Ontario |
| Canada | 1245.23.20022 Boehringer Ingelheim Investigational Site | Brampton | Ontario |
| Canada | 1245.23.20032 Boehringer Ingelheim Investigational Site | Calgary | Alberta |
| Canada | 1245.23.20035 Boehringer Ingelheim Investigational Site | Corunna | Ontario |
| Canada | 1245.23.20023 Boehringer Ingelheim Investigational Site | Edmonton | Alberta |
| Canada | 1245.23.20030 Boehringer Ingelheim Investigational Site | Etobicoke | Ontario |
| Canada | 1245.23.20026 Boehringer Ingelheim Investigational Site | Halifax | Nova Scotia |
| Canada | 1245.23.20037 Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
| Canada | 1245.23.20027 Boehringer Ingelheim Investigational Site | Laval | Quebec |
| Canada | 1245.23.20029 Boehringer Ingelheim Investigational Site | London | Ontario |
| Canada | 1245.23.20003 Boehringer Ingelheim Investigational Site | Markham | Ontario |
| Canada | 1245.23.20025 Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | 1245.23.20040 Boehringer Ingelheim Investigational Site | Oakville | Ontario |
| Canada | 1245.23.20024 Boehringer Ingelheim Investigational Site | Paradise | Newfoundland and Labrador |
| Canada | 1245.23.20034 Boehringer Ingelheim Investigational Site | Sarnia | Ontario |
| Canada | 1245.23.20036 Boehringer Ingelheim Investigational Site | Sherbrooke | Quebec |
| Canada | 1245.23.20031 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | 1245.23.20039 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | 1245.23.20028 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia |
| Canada | 1245.23.20033 Boehringer Ingelheim Investigational Site | Victoria | British Columbia |
| Canada | 1245.23.20038 Boehringer Ingelheim Investigational Site | Ville Saint-Laurent | Quebec |
| China | 1245.23.86031 Boehringer Ingelheim Investigational Site | Beijing | |
| China | 1245.23.86032 Boehringer Ingelheim Investigational Site | Beijing | |
| China | 1245.23.86033 Boehringer Ingelheim Investigational Site | Beijing | |
| China | 1245.23.86034 Boehringer Ingelheim Investigational Site | Beijing | |
| China | 1245.23.86035 Boehringer Ingelheim Investigational Site | Beijing | |
| China | 1245.23.86048 Boehringer Ingelheim Investigational Site | Chengdu | |
| China | 1245.23.86058 Boehringer Ingelheim Investigational Site | Chongqing | |
| China | 1245.23.86038 Boehringer Ingelheim Investigational Site | Dalian | |
| China | 1245.23.86002 Boehringer Ingelheim Investigational Site | Guangzhou | |
| China | 1245.23.86052 Boehringer Ingelheim Investigational Site | Guangzhou | |
| China | 1245.23.86037 Boehringer Ingelheim Investigational Site | Haerbin | |
| China | 1245.23.86049 Boehringer Ingelheim Investigational Site | Jinan | |
| China | 1245.23.86053 Boehringer Ingelheim Investigational Site | Jinan | |
| China | 1245.23.86055 Boehringer Ingelheim Investigational Site | Nan Ning | |
| China | 1245.23.86056 Boehringer Ingelheim Investigational Site | Nan Ning | |
| China | 1245.23.86042 Boehringer Ingelheim Investigational Site | Nanjing | |
| China | 1245.23.86043 Boehringer Ingelheim Investigational Site | Nanjing | |
| China | 1245.23.86039 Boehringer Ingelheim Investigational Site | Shanghai | |
| China | 1245.23.86040 Boehringer Ingelheim Investigational Site | Shanghai | |
| China | 1245.23.86054 Boehringer Ingelheim Investigational Site | Shantou | |
| China | 1245.23.86057 Boehringer Ingelheim Investigational Site | Shenyang | |
| China | 1245.23.86045 Boehringer Ingelheim Investigational Site | Shijiazhuang | |
| China | 1245.23.86013 Boehringer Ingelheim Investigational Site | Suzhou | |
| China | 1245.23.86036 Boehringer Ingelheim Investigational Site | Tianjin | |
| China | 1245.23.86041 Boehringer Ingelheim Investigational Site | Xi'An | |
| China | 1245.23.86051 Boehringer Ingelheim Investigational Site | Zhenjiang | |
| France | 1245.23.33015 Boehringer Ingelheim Investigational Site | Arras | |
| France | 1245.23.33008 Boehringer Ingelheim Investigational Site | Bersée | |
| France | 1245.23.33020 Boehringer Ingelheim Investigational Site | Bischheim | |
| France | 1245.23.33002 Boehringer Ingelheim Investigational Site | Bondy Cedex | |
| France | 1245.23.33016 Boehringer Ingelheim Investigational Site | Bruay La Buissiere | |
| France | 1245.23.33001 Boehringer Ingelheim Investigational Site | Corbeil Essonnes | |
| France | 1245.23.33010 Boehringer Ingelheim Investigational Site | Croix | |
| France | 1245.23.33009 Boehringer Ingelheim Investigational Site | Hautmont | |
| France | 1245.23.33003 Boehringer Ingelheim Investigational Site | La Rochelle Cedex 1 | |
| France | 1245.23.33045 Boehringer Ingelheim Investigational Site | Marseille | |
| France | 1245.23.33014 Boehringer Ingelheim Investigational Site | Mundolsheim | |
| France | 1245.23.33004 Boehringer Ingelheim Investigational Site | Narbonne Cedex | |
| France | 1245.23.33012 Boehringer Ingelheim Investigational Site | Schiltigheim | |
| France | 1245.23.33013 Boehringer Ingelheim Investigational Site | Strasbourg | |
| France | 1245.23.33019 Boehringer Ingelheim Investigational Site | Strasbourg | |
| France | 1245.23.33007 Boehringer Ingelheim Investigational Site | Vieux Condé | |
| France | 1245.23.33018 Boehringer Ingelheim Investigational Site | Wattrelos | |
| Germany | 1245.23.49001 Boehringer Ingelheim Investigational Site | Dormagen | |
| Germany | 1245.23.49009 Boehringer Ingelheim Investigational Site | Flörsheim | |
| Germany | 1245.23.49004 Boehringer Ingelheim Investigational Site | Hatten | |
| Germany | 1245.23.49007 Boehringer Ingelheim Investigational Site | Künzing | |
| Germany | 1245.23.49002 Boehringer Ingelheim Investigational Site | Neuwied | |
| Germany | 1245.23.49008 Boehringer Ingelheim Investigational Site | Nürnberg | |
| Germany | 1245.23.49010 Boehringer Ingelheim Investigational Site | Rednitzhembach | |
| Germany | 1245.23.49006 Boehringer Ingelheim Investigational Site | Rehburg-Loccum | |
| Germany | 1245.23.49011 Boehringer Ingelheim Investigational Site | Rehlingen-Siersburg | |
| Germany | 1245.23.49005 Boehringer Ingelheim Investigational Site | Saarbrücken | |
| Germany | 1245.23.49003 Boehringer Ingelheim Investigational Site | Unterschneidheim | |
| India | 1245.23.91101 Boehringer Ingelheim Investigational Site | Coimbatore | |
| India | 1245.23.91104 Boehringer Ingelheim Investigational Site | Indore | |
| India | 1245.23.91103 Boehringer Ingelheim Investigational Site | Maharashtra | |
| India | 1245.23.91102 Boehringer Ingelheim Investigational Site | Nagpur | |
| India | 1245.23.91105 Boehringer Ingelheim Investigational Site | Pune | |
| Korea, Republic of | 1245.23.82012 Boehringer Ingelheim Investigational Site | Anyang | |
| Korea, Republic of | 1245.23.82004 Boehringer Ingelheim Investigational Site | Busan | |
| Korea, Republic of | 1245.23.82011 Boehringer Ingelheim Investigational Site | Goyang | |
| Korea, Republic of | 1245.23.82009 Boehringer Ingelheim Investigational Site | Ilsan | |
| Korea, Republic of | 1245.23.82001 Boehringer Ingelheim Investigational Site | Incheon | |
| Korea, Republic of | 1245.23.82006 Boehringer Ingelheim Investigational Site | Jeonju | |
| Korea, Republic of | 1245.23.82005 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.23.82007 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.23.82008 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.23.82010 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.23.82014 Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | 1245.23.82002 Boehringer Ingelheim Investigational Site | Suwon | |
| Korea, Republic of | 1245.23.82003 Boehringer Ingelheim Investigational Site | Wonju | |
| Mexico | 1245.23.52003 Boehringer Ingelheim Investigational Site | Guadalajara | |
| Mexico | 1245.23.52004 Boehringer Ingelheim Investigational Site | Guadalajara | |
| Mexico | 1245.23.52001 Boehringer Ingelheim Investigational Site | Monterrey | |
| Mexico | 1245.23.52002 Boehringer Ingelheim Investigational Site | Monterrey | |
| Slovakia | 1245.23.74005 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 1245.23.74002 Boehringer Ingelheim Investigational Site | Lucenec | |
| Slovakia | 1245.23.74006 Boehringer Ingelheim Investigational Site | Nitra | |
| Slovakia | 1245.23.74014 Boehringer Ingelheim Investigational Site | Nove Zamky | |
| Slovakia | 1245.23.74001 Boehringer Ingelheim Investigational Site | Povazska Bystrica | |
| Slovakia | 1245.23.74004 Boehringer Ingelheim Investigational Site | Presov | |
| Slovakia | 1245.23.74003 Boehringer Ingelheim Investigational Site | Trebisov | |
| Slovenia | 1245.23.38003 Boehringer Ingelheim Investigational Site | Celje | |
| Slovenia | 1245.23.38002 Boehringer Ingelheim Investigational Site | Koper | |
| Slovenia | 1245.23.38001 Boehringer Ingelheim Investigational Site | Maribor | |
| Taiwan | 1245.23.88010 Boehringer Ingelheim Investigational Site | Kaohsiung | |
| Taiwan | 1245.23.88011 Boehringer Ingelheim Investigational Site | Kaohsiung | |
| Taiwan | 1245.23.88012 Boehringer Ingelheim Investigational Site | Kaohsiung | |
| Taiwan | 1245.23.88013 Boehringer Ingelheim Investigational Site | Kaohsiung | |
| Taiwan | 1245.23.88009 Boehringer Ingelheim Investigational Site | Taichung | |
| Taiwan | 1245.23.88014 Boehringer Ingelheim Investigational Site | Tainan | |
| Taiwan | 1245.23.88006 Boehringer Ingelheim Investigational Site | Taipei | |
| Taiwan | 1245.23.88007 Boehringer Ingelheim Investigational Site | Taipei | |
| Taiwan | 1245.23.88021 Boehringer Ingelheim Investigational Site | Taipei | |
| Taiwan | 1245.23.88008 Boehringer Ingelheim Investigational Site | Taoyuan County | |
| Turkey | 1245.23.90003 Boehringer Ingelheim Investigational Site | Erzurum | |
| Turkey | 1245.23.90001 Boehringer Ingelheim Investigational Site | Gaziantep | |
| Turkey | 1245.23.90002 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1245.23.90006 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1245.23.90007 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1245.23.90004 Boehringer Ingelheim Investigational Site | Izmir | |
| United States | 1245.23.10117 Boehringer Ingelheim Investigational Site | Arkansas City | Kansas |
| United States | 1245.23.10145 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1245.23.10001 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1245.23.10120 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1245.23.10080 Boehringer Ingelheim Investigational Site | Decatur | Georgia |
| United States | 1245.23.10159 Boehringer Ingelheim Investigational Site | Des Moines | Iowa |
| United States | 1245.23.10042 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | 1245.23.10156 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1245.23.10095 Boehringer Ingelheim Investigational Site | Huntington Park | California |
| United States | 1245.23.10109 Boehringer Ingelheim Investigational Site | Huntington Park | California |
| United States | 1245.23.10153 Boehringer Ingelheim Investigational Site | Hurst | Texas |
| United States | 1245.23.10133 Boehringer Ingelheim Investigational Site | Jupiter | Florida |
| United States | 1245.23.10143 Boehringer Ingelheim Investigational Site | Killeen | Texas |
| United States | 1245.23.10148 Boehringer Ingelheim Investigational Site | Lexington | Kentucky |
| United States | 1245.23.10074 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1245.23.10158 Boehringer Ingelheim Investigational Site | Mount Pleasant | South Carolina |
| United States | 1245.23.10157 Boehringer Ingelheim Investigational Site | Newton | Kansas |
| United States | 1245.23.10031 Boehringer Ingelheim Investigational Site | Oklahoma City | Oklahoma |
| United States | 1245.23.10149 Boehringer Ingelheim Investigational Site | Rancho Cucamonga | California |
| United States | 1245.23.10034 Boehringer Ingelheim Investigational Site | Rochester | New York |
| United States | 1245.23.10106 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1245.23.10015 Boehringer Ingelheim Investigational Site | Simpsonville | South Carolina |
| United States | 1245.23.10123 Boehringer Ingelheim Investigational Site | Smithtown | New York |
| United States | 1245.23.10046 Boehringer Ingelheim Investigational Site | Tempe | Arizona |
| United States | 1245.23.10127 Boehringer Ingelheim Investigational Site | Waterbury | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States, Canada, China, France, Germany, India, Korea, Republic of, Mexico, Slovakia, Slovenia, Taiwan, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Confirmed Hypoglycaemic Adverse Events | Number of patients with confirmed hypoglycaemic events, as reported as adverse events. | From first intake of randomised trial medication until 7 days after last trial medication intake, up to 231 days | No |
| Primary | HbA1c Change From Baseline | Change from baseline in HbA1c after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication. |
Baseline and 24 weeks | No |
| Secondary | Body Weight Change From Baseline | Body weight change from baseline after 24 weeks. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication. |
Baseline and 24 weeks | No |
| Secondary | Mean Daily Plasma Glucose (MDG) Change From Baseline | Change from baseline in mean daily glucose (MDG) using the 8-point blood glucose profile, after 24 weeks of treatment. For open-label groups the descriptive mean is provided, for randomised groups adjusted means are provided. The means are adjusted separately for metformin alone and metformin plus sulphonylurea background medication. |
Baseline and 24 weeks | No |
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|---|---|---|---|
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