NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Type 2 Diabetes
Date of first enrollment	13/09/2016
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Dulaglutide INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : Dulaglutide administered subcutaneously once weekly for 52 weeks. control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo administered subcutaneously once weekly for 16 weeks. And then, Dulaglutide administered subcutaneously once weekly for 36 weeks.

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. Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening. Participants who have an HbA1c value (greater than or equal 7.0%) and (less than or equal 10.5%) at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or (greater than or equal 7.5%) and (less than or equal 10.5%) at screening if the participant is not washing out OADs. Participants who have stable weight (+-5%) (greater than or equal 3 months) prior to screening. Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kilogram per square meter).
Exclude criteria