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CompletedNCT02561338Updated Mar 10, 2020Results posted

A Multi-center 12-week Study of HMS5552 in T2DM

A Phase 2 interventional study of HMS5552 and HMS5552 in Diabetes Mellitus, Type 2, sponsored by Hua Medicine Limited. Completed at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-03-10.

Sponsored by Hua Medicine Limited · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
258
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • GKA,T2DM,HMS5552
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 258 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male \& female, 40\~75 years old
  2. T2DM patients，anti-hyperglycemic drug-naïve and on diet \& exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
  3. HbA1c 7.5\~10.5% at screening and pre-randomization
  4. Fasting plasma glucose (FPG)7.0\~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0\~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
  5. BMI: 19\~30kg/m\^2 \& TG\<5.5mmol/L

Exclusion criteria

Exclusion Criteria:

  1. T1D，secondary DM, pre-DM
  2. kidney diseases or eGFR MDRD\<60ml/min/1.73m\^2
  3. unstable CVDs
  4. liver diseases
  5. mental or CNS diseases
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
258 participants (actual)

Study arms

  • Experimental
    HMS5552 dose 1

    75mgQD oral administration

    Drug: HMS5552

  • Experimental
    HMS5552 dose 2

    100mgQD oral administration

    Drug: HMS5552

  • Experimental
    HMS5552 dose 3

    50mgBID oral administration

    Drug: HMS5552

  • Experimental
    HMS5552 dose 4

    75mgBID oral administration

    Drug: HMS5552

  • Placebo comparator
    Placebo

    Placebo, BID/QD oral administration

    Other: Placebo

Interventions

  • DrugHMS5552

    75mgQD

    Also known as: GKA

  • DrugHMS5552

    100mgQD

    Also known as: GKA

  • DrugHMS5552

    50mgBID

    Also known as: GKA

  • DrugHMS5552

    75mgBID

    Also known as: GKA

  • OtherPlacebo

    QD/BID

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline and 12 weeks

  2. Change From Baseline in FPG

    Time frame: Baseline and 12 weeks

07

Results

Posted Mar 10, 2020

Participant flow

Participant flow — Overall Study
MilestoneHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Started5350515153
Completed4544424651
Not completed86952

Outcome measures

PrimaryAfter 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.

Time frame:
Baseline and 12 weeks
Reported as:
Least squares mean · Percentage of glycated hemoglobin
After 12-week Treatment, the Change From Baseline in HbA1c
Percentage of glycated hemoglobinHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
After 12-week Treatment, the Change From Baseline in HbA1c-0.39 (-0.64 to -0.16)-0.65 (-0.92 to -0.38)-0.79 (-1.06 to -0.52)-1.12 (-1.39 to -0.86)-0.35 (-0.60 to -0.10)
SecondaryChange 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.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · mmol/L
Change From Baseline in 2hPPG
mmol/LHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Change From Baseline in 2hPPG-4.669 ± 2.325-4.945 ± 3.387-3.898 ± 3.535-4.899 ± 3.921-1.987 ± 3.312
SecondaryChange From Baseline in FPG
Time frame:
Baseline and 12 weeks
Reported as:
Mean · mmol/L
Change From Baseline in FPG
mmol/LHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Change From Baseline in FPG-0.307 ± 2.000-0.382 ± 1.602-0.758 ± 2.150-1.319 ± 2.258-0.801 ± 1.752
Post-hocChange 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.

Time frame:
Baseline and week 12
Reported as:
Median · units on a scale
Change From Baseline in MMTT (Mixed Meal Tolerance Test) β-cell Function Index
units on a scaleHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Disposition Index0.292 (0.065 to 0.838)0.198 (-0.075 to 0.532)0.216 (0.008 to 0.532)0.140 (-0.010 to 0.580)0.080 (-0.061 to 0.265)
HOMA-IR-0.530 (-1.770 to 0.260)-0.520 (-2.050 to 0.150)-0.550 (-1.930 to 0.260)-1.185 (-2.485 to -0.385)-0.680 (-1.650 to 0.280)

Adverse events

Collected over From randomization to 7 days after 12-week treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HMS5552 Dose 10/53 (0%)1/53 (1.9%)16/53 (30.2%)
HMS5552 Dose 20/50 (0%)1/50 (2%)21/50 (42%)
HMS5552 Dose 30/51 (0%)1/51 (2%)13/51 (25.5%)
HMS5552 Dose 40/51 (0%)0/51 (0%)18/51 (35.3%)
Placebo0/53 (0%)0/53 (0%)15/53 (28.3%)
Most frequent serious events
Most frequent serious events
EventHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Right Cerebral Infarction Of Basal GangliaNervous system disorders0/531/500/510/510/53
Right Achilles Tendon RuptureInjury, poisoning and procedural complications0/530/501/510/510/53
Lacunar InfarctionNervous system disorders1/530/500/510/510/53
Most frequent other events
Showing 10 of 12
Most frequent other events
EventHMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4Placebo
Upper Respiratory Tract InfectionInfections and infestations6/536/501/514/513/53
HyperuricaemiaMetabolism and nutrition disorders3/536/503/514/512/53
Blood Creatine Phosphokinase IncreasedInvestigations0/531/501/511/515/53
DizzinessNervous system disorders2/534/504/510/510/53
High Density Lipoprotein DecreasedInvestigations1/530/501/514/511/53
Urinary Tract InfectionInfections and infestations1/533/500/511/513/53
White Blood Cells Urine PositiveInvestigations1/530/502/513/511/53
Hepatic Function AbnormalHepatobiliary disorders2/531/503/510/511/53
Ventricular ExtrasystolesCardiac disorders0/531/500/513/510/53
NasopharyngitisInfections and infestations0/531/503/510/510/53

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Mean57.58 ± 9.15956.7 ± 7.67054.92 ± 8.13755.42 ± 7.65954.73 ± 8.49955.88 ± 8.271
Sex: Female, Male
Sex: Female, Male(Participants)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Female2622161822104
Male2728343131151
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Hispanic or Latino000000
Not Hispanic or Latino5350504953255
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
American Indian or Alaska Native000000
Asian5350504953255
Native Hawaiian or Other Pacific Islander000000
Black or African American000000
White000000
More than one race000000
Unknown or Not Reported000000
Region of Enrollment
Region of Enrollment(participants)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
China5350504953255
HbA1c
HbA1c(percentage of glycated hemoglobin)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Mean8.44 ± 0.8038.27 ± 0.6398.33 ± 0.6538.46 ± 0.6708.39 ± 0.7808.38 ± 0.712
FPG
FPG(mmol/L)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Mean9.933 ± 2.33569.127 ± 1.48689.390 ± 1.53179.859 ± 1.99029.277 ± 1.76089.518 ± 1.8663
2h PPG
2h PPG(mmol/L)HMS5552 Dose 1HMS5552 Dose 2HMS5552 Dose 3HMS5552 Dose 4PlaceboTotal
Mean18.042 ± 3.300417.429 ± 3.202317.243 ± 3.094317.884 ± 3.130316.950 ± 3.728217.509 ± 3.3052

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China
09

References and documents

Publications

  • 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. Erratum In: Lancet Diabetes Endocrinol. 2018 Aug;6(8):e16. doi: 10.1016/S2213-8587(18)30151-7. PubMed 29735394 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02561338
Lead sponsor
Hua Medicine Limited
Collaborators
Tigermed Consulting Co., Ltd
Responsible party
Sponsor
First posted
Sep 28, 2015
Start date
Sep 2015
Primary completion
Sep 2016
Completion
Sep 2016
Results posted
Mar 10, 2020
Last update
Mar 10, 2020

Study contacts

Dalong Zhu, MD，PhD
principal investigator · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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