NIPH Clinical Trials Search

Basic Information

Recruitment status	recruiting
Health condition(s) or Problem(s) studied	Type 2 diabetes mellitus
Date of first enrollment	02/04/2012
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : LY2189265 INN of investigational material : Dulaglutide Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : Once-weekly subcutaneous (SC) injection of 0.75 mg LY2189265 control material(s) Generic name etc : Liraglutide INN of investigational material : Liraglutide Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : Once-daily SC injection of Liraglutide Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Once-weekly SC injection of placebo for 26 weeks, followed by 0.75 mg of SC LY2189265/week for an additional 26 weeks of open therapy

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Participants who have had a diagnosis of type 2 diabetes mellitus before screening -Participants who have been OAM-naive (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization -Participants who are OAM naive with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%. -Participants who have a body mass index (BMI) of 18.5kg/m2 to 35.0kg/m2
Exclude criteria