Diabetes Mellitus, Type 2Phase 3NCT04564872
HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing HSK7653 10 mg Q2W, HSK7653 25 mg Q2W and Linagliptin 5 mg QD in people with Diabetes Mellitus, Type 2, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 2 sites in China.
Trial summary
The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy. 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?
- HSK7653 10 mg Q2W, HSK7653 25 mg Q2W and Linagliptin 5 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 2 sitesChina
- Study dates
- 13 Nov 2020to 29 Aug 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
- Age ≥ 18 and ≤ 75 years, Male and female patients;
- Type 2 diabetes mellitus;
- Insufficient glycaemic control with diet/exercise therapy and metformin agent monotherapy;
- Did not receive regular long-term medication of oral hypoglycemic drugs (except metformin) or insulin within 1 year prior to informed consent;
- HbA1c in the range of ≥7.5 to ≤11.0% at screening;
- FPG < 15 mmol/L at screening;
- BMI (Body Mass Index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening.
Who cannot join
- Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
- History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent;
- Serious gastrointestinal disease within 2 weeks prior to informed consent;
- Serious infection, trauma, and surgery within 3 months prior to informed consent;
- History of treatment with Dipeptidyl-Peptidase 4 (DPP-4) inhibitor, Glucose-dependent insulinotropic polypeptide (GIP) or Glucagon-like peptide-1 (GLP-1) receptor agonist;
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- Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
- Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
- Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
- Active infectious diseases;
- Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
- Women who are nursing or pregnant, or subjects who have planned parenthood;
- Contraindication for empagliflozin or linagliptin;
- Other protocol-defined inclusion/exclusion criteria.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled Trial of the Efficacy and Safety of Adding HSK7653 to Metformin in Chinese Patients With Type 2 Diabetes and Inadequate Glycaemic Control
The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.
Read the detailed description
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653, or linagliptin, and with matching placebo respectively. During the open-label period, all participants will receive 25 mg dose of HSK7653. All participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HSK7653 10 mg Q2W, HSK7653 25 mg Q2W, Linagliptin 5 mg QD
- 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.
HSK7653 10 mg Q2WDrug
HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
HSK7653 25 mg Q2WDrug
HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.
Linagliptin 5 mg QDDrug
Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
| Study group | Role | What they receive |
|---|---|---|
| HSK7653 10 mg | Experimental | Not described Receives: Drug: HSK7653 10 mg Q2W |
| HSK7653 25 mg | Experimental | Not described Receives: Drug: HSK7653 25 mg Q2W |
| Linagliptin 5 mg | Active comparator | Not described Receives: Drug: Linagliptin 5 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Change From Baseline at Week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Measured: Baseline and week 24
Secondary outcomes (10)
Incidence of Treatment-Emergent Adverse Events
The incidence of Treatment-Emergent Adverse Events over time (at week 24 and week 52)
Measured: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%
Measured: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <6.5%
Measured: Baseline, week 24 and week 52
FPG Change From Baseline at Week 24 and Week 52
Measured: Baseline , week 24 and week 52
2h-PPG Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Weight Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Fasting C-peptide Change From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52
Measured: Baseline, week 24 and week 52
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia 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.
- First posted25 Sep 2020
- Study start13 Nov 2020
- Primary completion21 Jan 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564872
- Sponsor's protocol ID
- HSK7653-302
- Other IDs
- CTR20201724
- Status last verified
- Dec 2022
- First submitted
- 14 Sep 2020
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active-Controlled Trial of the Efficacy and Safety of Adding HSK7653 to Metformin in Chinese Patients With Type 2 Diabetes and Inadequate Glycaemic Control
- ClinicalTrials.gov ID
- NCT04564872
- Acronym / sponsor ID
- HSK7653-302
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of HSK7653 (as an add-on to metformin) compared with linagliptin after 24 weeks, and the safety (up to 52 weeks) of HSK7653 in Chinese patients with Type 2 Diabetes who have inadequate glycemic control on diet/exercise therapy and metformin agent monotherapy.
Detailed description
The treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). During the double-blind period, participants will receive 10 mg or 25 mg dose of HSK7653, or linagliptin, and with matching placebo respectively. During the open-label period, all participants will receive 25 mg dose of HSK7653. All participants will receive a stable dose of metformin therapy in both the double-blind period and the open-label period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HSK7653 10 mg | Experimental | Drug: HSK7653 10 mg Q2W |
| HSK7653 25 mg | Experimental | Drug: HSK7653 25 mg Q2W |
| Linagliptin 5 mg | Active comparator | Drug: Linagliptin 5 mg QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 75 years, Male and female patients;
- Type 2 diabetes mellitus;
- Insufficient glycaemic control with diet/exercise therapy and metformin agent monotherapy;
- Did not receive regular long-term medication of oral hypoglycemic drugs (except metformin) or insulin within 1 year prior to informed consent;
- HbA1c in the range of ≥7.5 to ≤11.0% at screening;
Key exclusion criteria (14 listed)
- Diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent;
- History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
- Current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent;
- Serious gastrointestinal disease within 2 weeks prior to informed consent;
- Serious infection, trauma, and surgery within 3 months prior to informed consent;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK7653 10 mg Q2WHSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52. | Drug | HSK7653 10 mg |
| HSK7653 25 mg Q2WHSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52. | Drug | HSK7653 25 mg |
| Linagliptin 5 mg QDLinagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52. | Drug | Linagliptin 5 mg |
Primary outcome
HbA1c Change From Baseline at Week 24
Time frame: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
10 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <7.0%
Time frame: Baseline, week 24 and week 52
Percentage of Patients With HbA1c <6.5%
Time frame: Baseline, week 24 and week 52
FPG Change From Baseline at Week 24 and Week 52
Time frame: Baseline , week 24 and week 52
2h-PPG Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Weight Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Fasting C-peptide Change From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Insulin Sensitivity Change (Calculated by HOMA-IS) From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Pancreatic β-cell function Change (Calculated by HOMA-β) From Baseline at Week 24 and Week 52
Time frame: Baseline, week 24 and week 52
Percentage of Patients Required Use of Rescue Therapy or Dropout due to Hyperglycemia and Week 52
Time frame: Baseline, week 24 and week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK7653 10 mg Q2W, HSK7653 25 mg Q2W and Linagliptin 5 mg QD in people with Diabetes Mellitus, Type 2, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 2 sites 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 7 inclusion and 14 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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 12 Dec 2022.