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Diabetes Mellitus, Type 2Phase 2NCT02561338

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

A Phase 2 study testing HMS5552 in people with Diabetes Mellitus, Type 2, run by Hua Medicine Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
HMS5552
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
1 siteChina
Study dates
Sep 2015to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, 12-week Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Population PK of HMS5552 in Type 2 Diabetic Adult Subjects

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).

Being tested
HMS5552, Placebo
Keywords
GKA,T2DM,HMS5552
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMS5552Drug

    Also called GKA

    75mgQD

  • HMS5552Drug

    Also called GKA

    100mgQD

  • HMS5552Drug

    Also called GKA

    50mgBID

  • HMS5552Drug

    Also called GKA

    75mgBID

  • PlaceboOther

    QD/BID

Study groups in NCT02561338
Study groupRoleWhat they receive
HMS5552 dose 1Experimental75mgQD oral administration
Receives: Drug: HMS5552
HMS5552 dose 2Experimental100mgQD oral administration
Receives: Drug: HMS5552
HMS5552 dose 3Experimental50mgBID oral administration
Receives: Drug: HMS5552
HMS5552 dose 4Experimental75mgBID oral administration
Receives: Drug: HMS5552
PlaceboPlacebo comparatorPlacebo, BID/QD oral administration
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 12 weeks

Secondary outcomes (2)

  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.

    Measured: Baseline and 12 weeks

  2. Change From Baseline in FPG

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02561338
Sponsor's protocol ID
HMM0201
Status last verified
Feb 2020
First submitted
23 Sep 2015
Last updated
10 Mar 2020
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 29735394

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HMS5552 in people with Diabetes Mellitus, Type 2, run by Hua Medicine Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

After 12-week Treatment, the Change From Baseline in HbA1c (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02561338, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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