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Clinical Trials List

Protocol Number1245.31
NCT Number(ClinicalTrials.gov Identfier)NCT01289990

2011-05-01 - 2013-06-30

Phase III

Terminated9

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.

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelheim

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Ting-I Lee Division of Endocrinology
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 黃建寧 Division of Endocrinology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 盧永川 Division of Endocrinology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 林興中 Division of Endocrinology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 陳榮福 Division of Endocrinology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 江珠影 Division of Endocrinology
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 何俊緯 Division of Endocrinology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 吳達仁 Division of Endocrinology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Type 2 diabetes

Objectives

The main objectives of the current study are to investigate 1) the long-term safety and tolerability of BI10773 (10 or 25mg once daily) and 2) the long-term efficacy of BI 10773 (10 and 25mg once daily) compared to: * sitagliptin (100mg once daily) or placebo as monotherapy (1245.20) * or placebo on a background of pioglitazone (1245. 19) *or placebo on a background of metformin with or without sulfonylurea (1245.23)

Test Drug

BI 10773

Active Ingredient

BI 10773

Dosage Form

Tablets

Dosage

10, 25

Endpoints

ㆍBody weight and waist circumference: Change from baseline to week 52 and 76.
ㆍ Fasting plasma glucose (FPG):
Change from baseline in fasting plasma glucose (FPG) after 52 and, 76 weeks of treatment.
ㆍ Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 52 and 76.

Inclution Criteria

1. Patients completing the entire treatment period of the preceding double-blind trial 1245.19, 1245.20 or 1245.23 with or without rescue therapy.
2. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.

Exclusion Criteria

1. 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.
2. Indication of liver discase, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during last visit of preceding trial.
3. Impaired renal function defined as eGFR<30 ml/min (severe renal impairment, MDRD formula) as determined during last visit of preceding trial.
4. Contraindications to sitagliptin, pioglitazone, metformin or sulfonylurea according to local label, which started during trial participation in 1245. 19, 1245.20 or 1245.23 5. Pre-menopausal women (last menstruation S I 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 vas
partner.
6.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.
7. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial (except I 245.19, 1245.20 and 1245.23) or participating in another trial (involving investigational drug and/or follow-up) after discontinuing medication in this trial.
8. Any other clinical condition that would jeopardize patient's safety while participating in this clinical trial.

The Estimated Number of Participants

  • Taiwan

    79 participants

  • Global

    0 participants

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