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Diabetes Mellitus, Type 2Phase 3NCT05782192

SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

A Phase 3 study testing SAL067 and Alogliptin in people with Diabetes Mellitus, Type 2, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. 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 is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
SAL067 and Alogliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
458 participants
Where
1 siteChina
Study dates
13 Jun 2019to 25 Mar 2022
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
  • Men or women aged 18 to 75 years old at the day of signing the informed consent;
  • Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)];
  • Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement);
  • Screening period and random time fasting blood glucose <=13.9mmol/L;

Who cannot join

  • Drug compliance during the introduction period <80% or >120%;
  • Use other hypoglycemic drugs other than test drugs during the introduction period;
  • The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin;
  • Before screening, have any of the following endocrine-related medical history or evidence:
  • Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;
  • diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening;
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  • severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia;
  • Before screening, there is a history or evidence of any of the following diseases:
  • Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);
  • Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia;
  • A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis;

Trial locations and contacts

1 site in 1 country.

China1 site

  • 1. Sun Yat-sen Memorial Hospital, Sun Yat-sen University,

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise

This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

Read the detailed description

All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.

Being tested
SAL067, Alogliptin, Placebo
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.

  • SAL067Drug

    Also called SAL067 Group

    SAL067 6mg(2 tablet) and placebo 25mg (1 tablet)

  • AlogliptinDrug

    Also called Alogliptin Group

    Alogliptin 25mg(1 tablet) and placebo 6mg (2 tablet)

  • PlaceboDrug

    Also called Placebo Group

    placebo 6mg (2 tablet) and placebo 25mg (1 tablet)

Study groups in NCT05782192
Study groupRoleWhat they receive
SAL067ExperimentalSAL067 12mg once daily
Receives: Drug: SAL067
AlogliptinActive comparatorAlogliptin 25mg once daily
Receives: Drug: Alogliptin
placeboPlacebo comparatorplacebo once daily
Receives: Drug: Placebo

What is being measured

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

  1. HbA1c change from baseline at week 24

    Change From Baseline in Hemoglobin A1c (HbA1c) at week 24

    Measured: Baseline and week 24

Secondary outcomes (7)

  1. HbA1c change from baseline at week 4、week 12、week 40 and week 52

    Change From Baseline in Hemoglobin A1c (HbA1c) at week 4、week 12、week 40 and week 52

    Measured: Baseline 、week 4、week 12、week 40 and week 52

  2. FPG change from baseline at week 4、week 8、week 12、week16、week24、week 40 and week 52

    Measured: Baseline、week 4、week 8、week 12、week16、week24、week 40 and week 52

  3. Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52

    Measured: Baseline 、week 24 and week 52

  4. Percentage of patients required use of rescue therapy at week 24 and week 52

    Measured: Baseline 、week 24 and week 52

  5. Fasting c-peptide change from baseline at week 24 and week 52

    Measured: Baseline 、week 24 and week 52

  6. Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52

    Measured: Baseline 、week 24 and week 52

  7. Pancreatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52

    Measured: Baseline 、week 24 and week 52

Timeline

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

  1. First posted23 Mar 2023
  2. Study start13 Jun 2019
  3. Primary completion25 Mar 2022
  4. Study completion25 Mar 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
458 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05782192
Sponsor's protocol ID
SAL067-C-009
Other IDs
CTR20192469, ChiCTR2000034343
Status last verified
Mar 2023
First submitted
9 Mar 2023
Last updated
23 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu M, Sun K, Xu W, Wang C, Yan D, Li S, Cong L, Pi Y, Song W, Sun Q, Xiao R, Peng W, Wang J, Peng H, Zhang Y, Duan P, Zhang M, Liu J, Huang Q, Li X, Bao Y, Zeng T, Wang K, Qin L, Wu C, Deng C, Huang C, Yan S, Zhang W, Li M, Sun L, Wang Y, Li H, Wang G, Pang S, Zheng X, Wang H, Wang F, Su X, Ma Y, Zhang W, Li Z, Xie Z, Xu N, Ni L, Zhang L, Deng X, Pan T, Dong Q, Wu X, Shen X, Zhang X, Zou Q, Jiang C, Xi J, Ma J, Sun J, Yan L. Fotagliptin monotherapy with alogliptin as an active comparator in patients with uncontrolled type 2 diabetes mellitus: a randomized, multicenter, double-blind, placebo-controlled, phase 3 trial. BMC Med. 2023 Oct 9;21(1):388. doi: 10.1186/s12916-023-03089-x.

    PubMed 37814306

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAL067 and Alogliptin in people with Diabetes Mellitus, Type 2, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. 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 11 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 23 Mar 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c change from baseline at week 24 (time frame: Baseline and week 24). 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 NCT05782192, 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 23 Mar 2023.

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