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Clinical Trials List

Protocol Number1245.23
NCT Number(ClinicalTrials.gov Identfier)NCT01289990

2010-09-01 - 2012-07-01

Phase III

Terminated9

ICD-10E11.9

Type 2 diabetes mellitus without complications

ICD-10E13.9

Other specified diabetes mellitus without complications

ICD-9250.00

Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled

A phase III randomized, double-blind, placebo-controlled, parallel trial to evaluate BI 10773 (10 mg, 25 mg) orally once a day for a 24 week course of treatment after treatment with Metformin or combined Metformin and Sulfonylurea Efficacy and safety of type 2 diabetes patients with poor blood glucose control

  • Trial Applicant

    Boehringer Ingelheim

  • Sponsor

    Boehringer Ingelhem

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 黃建寧 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ting-I Lee

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林興中

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 江珠影

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 盧永川

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 陳榮福

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Kun Der Lin

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 吳達仁

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Type 2 or unspecified diabetes

Objectives

1. To evaluate the efficacy, safety, and safety of BI 10773 (10 mg, 25 mg / one dose per day) or placebo for patients with type 2 diabetes who still have poor blood glucose control after receiving Metformin or Metformin and Sulfonylurea, respectively. Tolerability 2. No blind group: To evaluate the efficacy and safety of patients with very poor blood glucose control (HbA1c> 11%) after taking BI 10773 25 mg

Test Drug

BI 10773

Active Ingredient

BI 10773

Dosage Form

tab

Dosage

10/25

Endpoints

Glycated hemoglobin changes

Inclution Criteria

Type 2 diabetes

Exclusion Criteria

X

The Estimated Number of Participants

  • Taiwan

    200 participants

  • Global

    2460 participants