Safety and Efficacy of Empagliflozin (BI 10773) and Sitagliptin Versus Placebo Over 76 Weeks in Patients With Type 2 Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01289990
First received: January 31, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: BI 10773 Drug: Placebo Drug: Sitagliptin 100mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Changes from baseline in clinical laboratory values, changes from baseline of Albumin/creatinine ratio and use of rescue therapy after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
- To investigate the long-term safety and tolerability of BI 10773. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
- Incidence and intensity of adverse events, hypoglycaemic events, protocol-specified significant adverse events, cardiovascular events (Clinical Event Committee adjudication results) after 52, 76 weeks of treatment and at end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess efficacy of BI 10773 and for patients from 1245.20 sitagliptin for minimum 76 weeks compared to placebo as monotherapy or placebo on a background of pioglitazone or placebo on a background of metformin with or without sulfonylurea. [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
- The HbA1c, body weight (kg), waist circumference and fasting plasma glucose changes from baseline after 52, 76 weeks of treatment and to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
- Composite endpoint of the following conditions after 52, 76 weeks of treatment and to end of trial change from baseline in (all three fulfilled): - HbA1c > 0.5% - systolic blood pressure > 3 mmHg - weight >2% [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
- Systolic and diastolic blood pressure: Change from baseline after 52, 76 weeks of treatment and to end of trial For patients rolling over from 1245.20: - Change from baseline in biomarkers of insulin sensitivity and secretion to end of trial [ Time Frame: Treatment period (minimum 76 weeks) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1869 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BI 10773 low (drug naive)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Experimental: BI 10773 high (drug naive)
BI 10773 tablets once daily
|
Drug: Placebo
Placebo matching Sitagliptin
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
|
|
Placebo Comparator: Placebo (drug naive)
Placebo tablets matching BI 10773 / Sitagliptin once daily
|
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching Sitagliptin
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Active Comparator: Sitagliptin 100mg (drug naive)
Sitagliptin once daily
|
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Sitagliptin 100mg
Sitagliptin once daily
|
|
Experimental: BI 10773 low (pioglitazone)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Experimental: BI 10773 high (pioglitazone)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
|
|
Placebo Comparator: Placebo (pioglitazone)
Placebo tablets matching BI 10773 once daily
|
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Experimental: BI 10773 low (metformin)
BI 10773 tablets once daily
|
Drug: Placebo
Placebo matching BI 10773 high dose
Drug: BI 10773
BI 10773 tablets once daily
|
|
Experimental: BI 10773 high (metformin)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
|
|
Placebo Comparator: Placebo (metformin)
Placebo tablets matching BI 10773 once daily
|
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Experimental: BI 10773 low (metformin+sulfonylurea)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 high dose
|
|
Experimental: BI 10773 high (metformin+sulfonylurea)
BI 10773 tablets once daily
|
Drug: BI 10773
BI 10773 tablets once daily
Drug: Placebo
Placebo matching BI 10773 low dose
|
|
Placebo Comparator: Placebo (metformin+sulfonylurea)
Placebo tablets matching BI 10773
|
Drug: Placebo
Placebo matching BI 10773 low dose
Drug: Placebo
Placebo matching BI 10773 high dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice and local legislation.
Exclusion criteria:
- Patient who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.19, 1245.20 or 1245.23.
- Indication of liver disease, defined by serum levels of either alanine aminotransferase , aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during last visit of preceding trial.
- Impaired renal function defined as glomerular filtration rate<30 ml/min (severe renal impairment, Modification of Diet in Renal Disease formula) as determined during last visit of preceding trial.
- Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245.19, 1245.20 or 1245.23
- Pre-menopausal women (last menstruation < or = 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, oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
- 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.
- Participation in another trial with an investigational drug within 30 days prior to informed consent (except 1245.19, 1245.20 and 1245.23).
- Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289990
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| United States, Alabama | |
| 1245.31.10145 Boehringer Ingelheim Investigational Site | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| 1245.31.10162 Boehringer Ingelheim Investigational Site | |
| Glendale, Arizona, United States | |
| 1245.31.10124 Boehringer Ingelheim Investigational Site | |
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| Phoenix, Arizona, United States | |
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| United States, California | |
| 1245.31.10154 Boehringer Ingelheim Investigational Site | |
| Chino, California, United States | |
| 1245.31.10149 Boehringer Ingelheim Investigational Site | |
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| 1245.31.10131 Boehringer Ingelheim Investigational Site | |
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| United States, Colorado | |
| 1245.31.10038 Boehringer Ingelheim Investigational Site | |
| Northglenn, Colorado, United States | |
| United States, Connecticut | |
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| United States, Florida | |
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| United States, Illinois | |
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| United States, Iowa | |
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| United States, Kansas | |
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| Canada, Prince Edward Island | |
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| Ville Saint-Laurent, Quebec, Canada | |
| Canada, Saskatchewan | |
| 1245.31.20041 Boehringer Ingelheim Investigational Site | |
| Saskatoon, Saskatchewan, Canada | |
| China | |
| 1245.31.86031 Boehringer Ingelheim Investigational Site | |
| Beijing, China | |
| 1245.31.86008 Boehringer Ingelheim Investigational Site | |
| Beijing, China | |
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| Beijing, China | |
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| Beijing, China | |
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| Chongqing, China | |
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| Guiyang, China | |
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| Jinan, China | |
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| Jingzhou, China | |
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| Nan Ning, China | |
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| Nan Ning, China | |
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| Nanchang, China | |
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| Nanjing, China | |
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| Nanjing, China | |
| 1245.31.86016 Boehringer Ingelheim Investigational Site | |
| QingDao, China | |
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| Shanghai, China | |
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| Shantou, China | |
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| Shenyang, China | |
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| Shijiazhuang, China | |
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| Suzhou, China | |
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| Taiyuan, China | |
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| Tianjin, China | |
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| Xi'An, China | |
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| Xi'An, China | |
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| Xiamen, China | |
| France | |
| 1245.31.33008 Boehringer Ingelheim Investigational Site | |
| Bersée, France | |
| 1245.31.33020 Boehringer Ingelheim Investigational Site | |
| Bischheim, France | |
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| Bondy Cedex, France | |
| 1245.31.33016 Boehringer Ingelheim Investigational Site | |
| Bruay La Buissiere, France | |
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| Corbeil Essonnes, France | |
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| Croix, France | |
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| Hautmont, France | |
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| Schiltigheim, France | |
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| Strasbourg, France | |
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| Strasbourg, France | |
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| Vieux Condé, France | |
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| Wattrelos, France | |
| Germany | |
| 1245.31.49001 Boehringer Ingelheim Investigational Site | |
| Dormagen, Germany | |
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| Dresden, Germany | |
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| Düsseldorf, Germany | |
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| Flörsheim, Germany | |
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| Frankfurt, Germany | |
| 1245.31.49019 Boehringer Ingelheim Investigational Site | |
| Haag, Germany | |
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| Hatten, Germany | |
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| Hohenmölsen, Germany | |
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| Künzing, Germany | |
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| Neuwied, Germany | |
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| Nürnberg, Germany | |
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| Rednitzhembach, Germany | |
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| Rehburg-Loccum, Germany | |
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| Rehlingen-Siersburg, Germany | |
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| Saarbrücken, Germany | |
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| Schauenburg, Germany | |
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| St. Ingbert/Oberwürzbach, Germany | |
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| Greece | |
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| India | |
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| Bangalore, India | |
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| Bangalore, India | |
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| 1245.31.35304 Boehringer Ingelheim Investigational Site | |
| Birr, Co. Offaly, Ireland | |
| 1245.31.35302 Boehringer Ingelheim Investigational Site | |
| Co. Cork, Ireland | |
| 1245.31.35305 Boehringer Ingelheim Investigational Site | |
| Co. Galway, Ireland | |
| 1245.31.35303 Boehringer Ingelheim Investigational Site | |
| Co. Wexford, Ireland | |
| 1245.31.35306 Boehringer Ingelheim Investigational Site | |
| Co. Wexford, Ireland | |
| Japan | |
| 1245.31.81007 Boehringer Ingelheim Investigational Site | |
| Chiyoda-ku, Tokyo, Japan | |
| 1245.31.81001 Boehringer Ingelheim Investigational Site | |
| Chuo-ku, Tokyo, Japan | |
| 1245.31.81002 Boehringer Ingelheim Investigational Site | |
| Chuo-ku, Tokyo, Japan | |
| 1245.31.81005 Boehringer Ingelheim Investigational Site | |
| Ebetsu, Hokkaido, Japan | |
| 1245.31.81004 Boehringer Ingelheim Investigational Site | |
| Kamakura, Kanagawa, Japan | |
| 1245.31.81003 Boehringer Ingelheim Investigational Site | |
| Minato-ku, Tokyo, Japan | |
| 1245.31.81006 Boehringer Ingelheim Investigational Site | |
| Shinjuku-ku, Tokyo, Japan | |
| 1245.31.81008 Boehringer Ingelheim Investigational Site | |
| Shinjuku-ku, Tokyo, Japan | |
| 1245.31.81009 Boehringer Ingelheim Investigational Site | |
| Suita, Osaka, Japan | |
| 1245.31.81010 Boehringer Ingelheim Investigational Site | |
| Ube, Yamaguchi, Japan | |
| 1245.31.81012 Boehringer Ingelheim Investigational Site | |
| Urasoe, Okinawa, Japan | |
| 1245.31.81013 Boehringer Ingelheim Investigational Site | |
| Urasoe, Okinawa, Japan | |
| Korea, Republic of | |
| 1245.31.82012 Boehringer Ingelheim Investigational Site | |
| Anyang, Korea, Republic of | |
| 1245.31.82011 Boehringer Ingelheim Investigational Site | |
| Goyang, Korea, Republic of | |
| 1245.31.82009 Boehringer Ingelheim Investigational Site | |
| Ilsan, Korea, Republic of | |
| 1245.31.82001 Boehringer Ingelheim Investigational Site | |
| Incheon, Korea, Republic of | |
| 1245.31.82006 Boehringer Ingelheim Investigational Site | |
| Jeonju, Korea, Republic of | |
| 1245.31.82004 Boehringer Ingelheim Investigational Site | |
| Pusan, Korea, Republic of | |
| 1245.31.82008 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1245.31.82005 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1245.31.82007 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1245.31.82010 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1245.31.82014 Boehringer Ingelheim Investigational Site | |
| Seoul, Korea, Republic of | |
| 1245.31.82002 Boehringer Ingelheim Investigational Site | |
| Suwon, Korea, Republic of | |
| 1245.31.82003 Boehringer Ingelheim Investigational Site | |
| Wonju, Korea, Republic of | |
| Mexico | |
| 1245.31.52003 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Mexico | |
| 1245.31.52004 Boehringer Ingelheim Investigational Site | |
| Guadalajara, Mexico | |
| 1245.31.52002 Boehringer Ingelheim Investigational Site | |
| Monterrey, Mexico | |
| 1245.31.52001 Boehringer Ingelheim Investigational Site | |
| Monterrey, Mexico | |
| Philippines | |
| 1245.31.63002 Boehringer Ingelheim Investigational Site | |
| Cebu, Philippines | |
| 1245.31.63003 Boehringer Ingelheim Investigational Site | |
| Davao City, Philippines | |
| 1245.31.63001 Boehringer Ingelheim Investigational Site | |
| Manila, Philippines | |
| 1245.31.63004 Boehringer Ingelheim Investigational Site | |
| Manila, Philippines | |
| 1245.31.63005 Boehringer Ingelheim Investigational Site | |
| Manila, Philippines | |
| Slovakia | |
| 1245.31.74005 Boehringer Ingelheim Investigational Site | |
| Bratislava, Slovakia | |
| 1245.31.74002 Boehringer Ingelheim Investigational Site | |
| Lucenec, Slovakia | |
| 1245.31.74006 Boehringer Ingelheim Investigational Site | |
| Nitra, Slovakia | |
| 1245.31.74014 Boehringer Ingelheim Investigational Site | |
| Nove Zamky, Slovakia | |
| 1245.31.74001 Boehringer Ingelheim Investigational Site | |
| Povazska Bystrica, Slovakia | |
| 1245.31.74004 Boehringer Ingelheim Investigational Site | |
| Presov, Slovakia | |
| 1245.31.74003 Boehringer Ingelheim Investigational Site | |
| Trebisov, Slovakia | |
| Slovenia | |
| 1245.31.38003 Boehringer Ingelheim Investigational Site | |
| Celje, Slovenia | |
| 1245.31.38002 Boehringer Ingelheim Investigational Site | |
| Koper, Slovenia | |
| 1245.31.38001 Boehringer Ingelheim Investigational Site | |
| Maribor, Slovenia | |
| Switzerland | |
| 1245.31.41004 Boehringer Ingelheim Investigational Site | |
| Lugano, Switzerland | |
| 1245.31.41003 Boehringer Ingelheim Investigational Site | |
| Rorschach, Switzerland | |
| Taiwan | |
| 1245.31.88010 Boehringer Ingelheim Investigational Site | |
| Kaohsiung, Taiwan | |
| 1245.31.88011 Boehringer Ingelheim Investigational Site | |
| Kaohsiung, Taiwan | |
| 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital | |
| Kaohsiung, Taiwan | |
| 1245.31.88012 Boehringer Ingelheim Investigational Site | |
| Kaohsiung, Taiwan | |
| 1245.31.88009 Boehringer Ingelheim Investigational Site | |
| Taichung, Taiwan | |
| 1245.31.88014 Boehringer Ingelheim Investigational Site | |
| Tainan, Taiwan | |
| 1245.31.88006 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| 1245.31.88021 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| 1245.31.88008 Boehringer Ingelheim Investigational Site | |
| Taoyuan County, Taiwan | |
| Turkey | |
| 1245.31.90003 Boehringer Ingelheim Investigational Site | |
| Erzurum, Turkey | |
| 1245.31.90001 Boehringer Ingelheim Investigational Site | |
| Gaziantep, Turkey | |
| 1245.31.90002 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1245.31.90006 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1245.31.90004 Boehringer Ingelheim Investigational Site | |
| Izmir, Turkey | |
| Ukraine | |
| 1245.31.75002 Boehringer Ingelheim Investigational Site | |
| Dnepropetrovsk, Ukraine | |
| 1245.31.75001 Boehringer Ingelheim Investigational Site | |
| Kharkiv, Ukraine | |
| 1245.31.75006 Boehringer Ingelheim Investigational Site | |
| Lviv, Ukraine | |
| 1245.31.75004 Boehringer Ingelheim Investigational Site | |
| Vinnitsa, Ukraine | |
| 1245.31.75003 Boehringer Ingelheim Investigational Site | |
| Vinnytsya, Ukraine | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Eli Lilly and Company
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01289990 History of Changes |
| Other Study ID Numbers: | 1245.31, 2010-022718-17 |
| Study First Received: | January 31, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal and Health Products Canada: Health Canada China: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: Ethics Committee India: Drugs Controller General of India Ireland: Irish Medicines Board Japan: Ministry of Health, Labor and Welfare Mexico: Federal Commission for Sanitary Risks Protection Philippines: Department of Health Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health South Korea: Ministry of Food and Drug Safety (MFDS) Switzerland: Swissmedic Taiwan: Turkey: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013