NIPH Clinical Trials Search

Basic Information

Recruitment status	completed
Health condition(s) or Problem(s) studied	Type 2 Diabetes Mellitus
Date of first enrollment	31/10/2017
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 is weekly administered subcutaneously for 4 weeks, after the period, placebo is weekly administered subcutaneously for 4 weeks. control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo is weekly administered subcutaneously for 4 weeks, after the period, dulaglutide is weekly administered subcutaneously for 4 weeks.

Outcome(s)

Primary Outcome
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 75age old
Gender	Both
Include criteria	- Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year. - Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening). - Have a fasting blood glucose value of =<120 and =>200 milligrams per deciliter (mg/dL) at screening. - Have a screening body weight of =<50 and =>80 kilograms.
Exclude criteria	- Have known allergies to dulaglutide, or other glucagon-like peptide-1(GLP-1) receptor agonists. - Have had a clinically significant cardiovascular disease. - Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery. - Have acute or chronic hepatitis, signs and symptoms of any other liver disease. - Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis. - Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared. - In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.