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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.
Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS5552 dose 1 | Experimental | 75mgQD oral administration |
|
| HMS5552 dose 2 | Experimental | 100mgQD oral administration |
|
| HMS5552 dose 3 | Experimental | 50mgBID oral administration |
|
| HMS5552 dose 4 | Experimental | 75mgBID oral administration |
|
| Placebo | Placebo Comparator | Placebo, BID/QD oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug | 75mgQD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| After 12-week Treatment, the Change From Baseline in HbA1c | Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 2hPPG | Using a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, MD，PhD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29735394 | Derived | Zhu D, Gan S, Liu Y, Ma J, Dong X, Song W, Zeng J, Wang G, Zhao W, Zhang Q, Li Y, Fang H, Lv X, Shi Y, Tian H, Ji L, Gao X, Zhang L, Bao Y, Lei M, Li L, Zeng L, Li X, Hou X, Zhao Y, Hu T, Ge X, Zhao G, Li Y, Zhang Y, Chen L. Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Diabetes Endocrinol. 2018 Aug;6(8):627-636. doi: 10.1016/S2213-8587(18)30105-0. Epub 2018 May 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HMS5552 Dose 1 | HMS5552: 75mgQD |
| FG001 | HMS5552 Dose 2 | HMS5552: 100mgQD |
| FG002 | HMS5552 Dose 3 | HMS5552: 50mgBID |
| FG003 | HMS5552 Dose 4 | HMS5552: 75mgBID |
| FG004 | Placebo | Placebo, BID/QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.
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| ID | Title | Description |
|---|---|---|
| BG000 | HMS5552 Dose 1 | HMS5552: 75mgQD |
| BG001 | HMS5552 Dose 2 | HMS5552: 100mgQD |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | After 12-week Treatment, the Change From Baseline in HbA1c | Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of glycated hemoglobin | Baseline and 12 weeks |
|
From randomization to 7 days after 12-week treatment
Note: Hypoglycemia in this study was collected and analyzed as Special attention event separated from the analysis of Any other Advance Event. The Number Affected by Hypoglycemia was not included in the Total Number Affected by Any Other (Not including Serious) Adverse Event Above the Frequency Threshold in the third table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HMS5552 Dose 1 | HMS5552: 75mgQD | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Achilles Tendon Rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yi Zhang | Hua Medicine | +86-21-58869997 | 3269 | yzhang@huamedicine.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000629807 | Dorzagliatin |
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| HMS5552 |
| Drug |
100mgQD |
|
|
| HMS5552 | Drug | 50mgBID |
|
|
| HMS5552 | Drug | 75mgBID |
|
|
| Placebo | Other | QD/BID |
|
| Baseline and 12 weeks |
| Change From Baseline in FPG | Baseline and 12 weeks |
| HMS5552 Dose 3 |
HMS5552: 50mgBID |
| BG003 | HMS5552 Dose 4 | HMS5552: 75mgBID |
| BG004 | Placebo | Placebo: BID/QD |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| FPG | Mean | Standard Deviation | mmol/L |
|
| 2h PPG | Mean | Standard Deviation | mmol/L |
|
| Body Mass Index (BMI) units: kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Diagnosis time | Mean | Standard Deviation | years |
|
| OG002 | HMS5552 Dose 3 | HMS5552: 50mgBID |
| OG003 | HMS5552 Dose 4 | HMS5552: 75mgBID |
| OG004 | Placebo | Placebo:BID/QD |
|
|
| Secondary | Change From Baseline in 2hPPG | Using a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks |
|
|
|
| Secondary | Change From Baseline in FPG | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks |
|
|
|
| Post-Hoc | Change From Baseline in MMTT (Mixed Meal Tolerance Test) β-cell Function Index | Disposition index, i.e DI, by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. HOMA IR is an index used to evaluate the individual's insulin resistance level. The HOMA-IR index of normal individuals is 1. With the increase of insulin resistance, HOMA-IR index will be higher than 1. | Both of disposition index and HOMA-IR could reflect the function of β cell. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and week 12 |
|
|
|
| 53 |
| 1 |
| 53 |
| 16 |
| 53 |
| EG001 | HMS5552 Dose 2 | HMS5552: 100mgQD | 0 | 50 | 1 | 50 | 21 | 50 |
| EG002 | HMS5552 Dose 3 | HMS5552: 50mgBID | 0 | 51 | 1 | 51 | 13 | 51 |
| EG003 | HMS5552 Dose 4 | HMS5552: 75mgBID | 0 | 51 | 0 | 51 | 18 | 51 |
| EG004 | Placebo | Placebo: BID/QD | 0 | 53 | 0 | 53 | 15 | 53 |
| Lacunar Infarction | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Right Cerebral Infarction Of Basal Ganglia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
|
| Protein Urine Present | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| White Blood Cells Urine Positive | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
|
| High Density Lipoprotein Decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
|
| HOMA-IR |
|
|