NCT03141073

Brief Summary

This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
767

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_3 diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

April 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

August 26, 2021

Status Verified

February 1, 2021

Enrollment Period

3.4 years

First QC Date

April 28, 2017

Last Update Submit

August 24, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

GKAT2DMHMS5552Add-on therapyMetformin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment

    24 weeks

Secondary Outcomes (5)

  • The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline

    24 weeks

  • The change of fasting plasma glucose (FPG) from baseline

    24 weeks

  • The proportion of subjects with HbA1c < 7.0%

    24 weeks

  • The change of HbA1c from baseline at each visit over time, except at Week 24

    24 weeks

  • Incidence of Treatment-Emergent Adverse Events over time

    52 weeks

Study Arms (2)

HMS5552

EXPERIMENTAL

75mg BID

Drug: HMS5552

Placebo

PLACEBO COMPARATOR

BID

Drug: Placebo

Interventions

HMS5552DRUG

BID oral administration

Also known as: Glucokinase Activator (GKA)
HMS5552
PlaceboDRUG

BID oral administration

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 18\~75 years old;
  • T2DM and treated with Metformin ≥ 1500mg/day constantly for at least 12 consecutive weeks;
  • % ≤ HbA1c ≤ 10.0% at screening;
  • kg/m2 \< BMI \< 35.0 kg/m2 at screening;

You may not qualify if:

  • Any anti-diabetic therapy other than Metformin within 12 weeks before screening;
  • Received insulin therapy more than 30 days within 1 year before screening;
  • Fasting C-peptide \<0.81 ng/ml (0.27 nmol/L) at screening;
  • Medical history of severe hypoglycemia or frequent hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular, unstable or rapidly progressive kidney disease, active liver diseases, diagnosed mental disease etc.
  • T1DM;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hua Medicine Limited

Shanghai, China

Location

Related Publications (1)

  • Yang W, Zhu D, Gan S, Dong X, Su J, Li W, Jiang H, Zhao W, Yao M, Song W, Lu Y, Zhang X, Li H, Wang G, Qiu W, Yuan G, Ma J, Li W, Li Z, Wang X, Zeng J, Yang Z, Liu J, Liang Y, Lu S, Zhang H, Liu H, Liu P, Fan K, Jiang X, Li Y, Su Q, Ning T, Tan H, An Z, Jiang Z, Liu L, Zhou Z, Zhang Q, Li X, Shan Z, Xue Y, Mao H, Shi L, Ye S, Zhang X, Sun J, Li P, Yang T, Li F, Lin J, Zhang Z, Zhao Y, Li R, Guo X, Yao Q, Lu W, Qu S, Li H, Tan L, Wang W, Yao Y, Chen D, Li Y, Gao J, Hu W, Fei X, Wu T, Dong S, Jin W, Li C, Zhao D, Feng B, Zhao Y, Zhang Y, Li X, Chen L. Dorzagliatin add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. 2022 May;28(5):974-981. doi: 10.1038/s41591-022-01803-5. Epub 2022 May 12.

    PMID: 35551292DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dorzagliatinglucokinase activator compound 50

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Wenying Yang, MD

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

April 28, 2017

First Posted

May 4, 2017

Study Start

October 15, 2017

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

August 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)