A Phase 1 interventional study of Metformin and HMS5552 in Type 2 Diabetes Mellitus, sponsored by Hua Medicine Limited. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-17.
Sponsored by Hua Medicine Limited · Phase 1, Interventional, and Treatment
This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).
This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM). The study is to assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM. The study is also to evaluate the safety and tolerability of HMS5552 with simultaneous administration of metformin in subjects with T2DM.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hua Medicine Limited is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
All subjects will receive the following: * Metformin500 mg BID on Days 1-2, only the morning dose on Day 3. Metformin will be taken 30 minutes prior to meals; * Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals; * HMS5552 50 mg BID on Days 9 -12, only the morning dose on Day 13. HMS5552 will be taken 30 minutes prior to meals.
Drug: Metformin · Drug: HMS5552
* Metformin500 mg BID on Days 1-2, only the morning dose on Day 3. Metformin will be taken 30 minutes prior to meals; * Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals
Also known as: Glucophage®
* Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals; * HMS5552 50 mg BID on Days 9 -12, only the morning dose on Day 13. HMS5552 will be taken 30 minutes prior to meals.
Also known as: GKA
The primary pharmacokinetics parameters of Cmax To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
HMS5552 and metformin PK parameters: PK parameters (Cmax) will be computed for each subject per day with non-compartmental methods using the actual sampling times. Descriptive statistics will be calculated for the PK parameters per day (Days 3, 8 and 13). The effect of metformin on the exposure of HMS5552 will be determined by a PK comparison between the exposure of HMS5552 on Day 13 vs. on Day 8. The effect of HMS5552 on the exposure of metformin will be determined by a PK comparison between the exposure of metformin on Day 8 vs. on Day 3.
Time frame: 13 days
The pharmacokinetics parameters of Tmax To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
HMS5552 and metformin PK parameters: PK parameters ( Tmax) will be computed for each subject per day with non-compartmental methods using the actual sampling times. Descriptive statistics will be calculated for the PK parameters per day (Days 3, 8 and 13). The effect of metformin on the exposure of HMS5552 will be determined by a PK comparison between the exposure of HMS5552 on Day 13 vs. on Day 8. The effect of HMS5552 on the exposure of metformin will be determined by a PK comparison between the exposure of metformin on Day 8 vs. on Day 3.
Time frame: 13 days
The pharmacokinetics parameters of AUC0-24hr To assess the potential pharmacokinetic interaction between HMS5552 and metformin in subjects with T2DM
HMS5552 and metformin PK parameters: PK parameters (AUC0-24hr) will be computed for each subject per day with non-compartmental methods using the actual sampling times. Descriptive statistics will be calculated for the PK parameters per day (Days 3, 8 and 13). The effect of metformin on the exposure of HMS5552 will be determined by a PK comparison between the exposure of HMS5552 on Day 13 vs. on Day 8. The effect of HMS5552 on the exposure of metformin will be determined by a PK comparison between the exposure of metformin on Day 8 vs. on Day 3.
Time frame: 13 days
Safety assessments includes monitoring of adverse events (AEs), vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, resting 12-lead electrocardiograms (ECGs), and physical examination findings.
Safety assessments will include monitoring of adverse events (AEs), blood glucose via glucometer readings, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, resting 12-lead electrocardiograms (ECGs), and physical examination findings on Day 13 , Day 8 and Day-1
Time frame: 13 days
Pharmacodynamic responses (serum levels) of glucose, insulin and C-peptide will be evaluated.
Time frame: 13 days
Plan to share: No
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Hua Medicine Limited