Chiglitazar
DrugTake orally
Other names: CS038
NCT Number: NCT02173457
The purpose of this study is to evaluate the efficacy and safety of Chiglitazar, compare with Sitagliptin.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
Anhui Provincial Hospital, Hefei, Anhui, China
The efficacy and safety will be compared between Chiglitazar and Sitagliptin after treatment of 24 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Take orally
Other names: CS038
Take orally
Other names: Sit
Time frame: 24 weeks
The change of HbA1c at week 24 from baseline
Time frame: 24 weeks
The change of HbA1c at week 24 from baseline for patients with a HbA1c >=8.5% at baseline
Time frame: 24 weeks
The change of HbA1c at week 24 from baseline for patients with a HbA1c < 8.5% at baseline
Time frame: 12 weeks
The change of HbA1c at week 12 from baseline
Time frame: 24 weeks
Percentage of patients whose HbA1c at week 24 are < 7.0%
Time frame: 24 weeks
Percentage of patients whose change of HbA1c at week 24d from baseline are >= 0.5%
Time frame: 12 and 24 weeks
The change of fasting plasma glucose at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of 2-h postprandial glucose (2hPPG) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of total cholesterol (TC) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of triglyceride at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of high density lipoprotein cholesterol (HDL-C) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of low density lipoprotein cholesterol (LDL-C) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of free fatty acid (FFA) at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of fasting plasma insulin at week 12 and 24 from baseline
Time frame: 12 and 24 weeks
The change of insulin sensitivity at week 12 and 24 from baseline
Time frame: 24 weeks
The change of blood pressure at week 24 from baseline
Time frame: 24 weeks
The percentage of patients who discontinue the trial due to hyperglycemia during the 24 weeks of treatment
Chipscreen Biosciences, Ltd.
Industry
Phase III Study of Chiglitazar in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control Despite Diet and Exercise -- A Multicenter, Randomized, Double-Blind, and Sitagliptin-Controlled Trial
Acronym: CMAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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