NCT02561338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

September 23, 2015

Results QC Date

February 5, 2018

Last Update Submit

February 25, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

GKA,T2DM,HMS5552

Outcome Measures

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.

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Change From Baseline in 2hPPG

    Baseline and 12 weeks

  • Change From Baseline in FPG

    Baseline and 12 weeks

Study Arms (5)

HMS5552 dose 1

EXPERIMENTAL

75mgQD oral administration

Drug: HMS5552

HMS5552 dose 2

EXPERIMENTAL

100mgQD oral administration

Drug: HMS5552

HMS5552 dose 3

EXPERIMENTAL

50mgBID oral administration

Drug: HMS5552

HMS5552 dose 4

EXPERIMENTAL

75mgBID oral administration

Drug: HMS5552

Placebo

PLACEBO COMPARATOR

Placebo, BID/QD oral administration

Other: Placebo

Interventions

HMS5552DRUG

75mgQD

Also known as: GKA
HMS5552 dose 1
PlaceboOTHER

QD/BID

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male \& female, 40\~75 years old
  • 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
  • HbA1c 7.5\~10.5% at screening and pre-randomization
  • 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
  • BMI: 19\~30kg/m\^2 \& TG\<5.5mmol/L

You may not qualify if:

  • T1D，secondary DM, pre-DM
  • kidney diseases or eGFR MDRD\<60ml/min/1.73m\^2
  • unstable CVDs
  • liver diseases
  • mental or CNS diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

Related Publications (1)

  • 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.

    PMID: 29735394DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Yi Zhang
Organization
Hua Medicine
yzhang@huamedicine.com
+86-21-58869997

Study Officials

  • Dalong Zhu, MD，PhD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 28, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 10, 2020

Results First Posted

March 10, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)