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Type 2 DiabetesPhase 3NCT05054842

Clinical Study of Retagliptin Phosphate Combined With Metformin in the Treatment of Type 2 Diabetes

A Phase 3 study testing Retagliptin phosphate tablets、metformin sustained-release tablets in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Retagliptin phosphate tablet is a DPP IV inhibitor durg，study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Retagliptin phosphate tablets、metformin sustained-release tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
1 siteChina
Study dates
6 Dec 2021to Dec 2023
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

  • Voluntarily signed the informed consent, understood the procedures and methods of the study, and was willing to complete the study strictly in accordance with the clinical trial protocol;
  • The screening age should be 18-75 years old (including both ends), male or female;
  • Diagnosed with type 2 diabetes, 7.5%≤HbA1c≤11%;
  • At least 8 weeks prior to screening, in addition to regular diet control and exercise, a steady dose of metformin ≥1500mg/d;
  • Fasting glucose ≤13.3mmol/L; 6、19.0 < BMI 35.0 kg/m2 or less.

Who cannot join

  • General situation:
  • 1) Known or suspected allergy to DPP4i drugs or investigational drug excipients;
  • 2) Pregnant or lactating women, fertile men or women were unwilling to use contraception during the study period;
  • History or evidence of any of the following diseases at the time of screening:
  • 1) Type 1 diabetes, single-gene mutation diabetes, diabetes due to pancreatic damage, or other secondary diabetes (e.g., diabetes due to Cushing's syndrome or acromegaly);
  • 2) Acute metabolic complications (such as ketoacidosis, lactic acidosis or hypertonic coma) occurred within 6 months prior to screening; Or have serious chronic complications of diabetes in the past (such as severe macrovascular or microvascular complications as judged by the investigator) and the investigator considers that they are not suitable to participate in this study;
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  • 3) There is a history of severe hypoglycemia (such as drowsiness, disturbance of consciousness, delirium, or even coma caused by hypoglycemia, which requires the assistance of others for treatment), or repeated hypoglycemia (≥3 symptomatic hypoglycemia within a week, or blood glucose <3.0 mmol/L detected at least 3 times within a week);
  • 4) Patients with poorly controlled hypertension at screening were defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg;
  • 5) Had myocardial infarction, unstable angina, stroke (except lacunar infarction without attack symptoms) or transient ischemic attack, or had undergone coronary angioplasty, percutaneous coronary stent implantation or coronary artery bypass grafting within 6 months prior to screening; Or had congestive heart failure (NYHA grades III and IV), unstable or acute congestive heart failure, or persistent arrhythmias that the investigator determined significantly affected the subjects' safety within the 6 months prior to screening;
  • 6) History of acute and chronic pancreatitis, or risk factors that may lead to pancreatitis, such as history of symptomatic gallbladder, history of pancreatic injury, etc. (except cholecystectomy);
  • 7) A history of malignant tumor within 5 years prior to screening, excluding treated local basal cell carcinoma of the skin;
  • 8) have obvious diseases of the blood system (such as aplastic anemia, myelodysplastic syndrome, hemolytic anemia) or any diseases causing hemolysis or red blood cell instability (such as malaria);
  • 9) Clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., active ulcers within 6 months prior to screening);
  • 10) There is a history of drug or alcohol abuse within 3 months prior to screening, which may affect the subject's compliance to participate in the test according to the investigator's judgment;
  • Received any of the following pharmacological or non-pharmacological treatments or procedures prior to screening:
  • 1) Any hypoglycemic drug treatment other than metformin within 2 months prior to screening, including Chinese herbal therapy for hypoglycemic purposes (except cumulative use ≤7 days);
  • 2) received systemic steroid hormone therapy (including intravenous and oral administration) and intraarticular administration for more than 7 days within 2 months prior to screening;
  • 3) Bariatric surgery or procedures (e.g. gastric banding surgery) within 12 months prior to screening, or use of weight-loss medications within 3 months prior to screening, or weight fluctuation ≥10% within 3 months prior to screening;
  • 4) Have received other gastrointestinal surgery that may lead to malabsorption before screening, or long-term use of drugs that directly affect gastrointestinal motility;
  • 5) Have received blood transfusion, blood donation or blood loss ≥400 mL within 3 months before screening;
  • 6) Participated in clinical trials of any drug or medical device within 3 months prior to screening (subject to entering into randomised procedures);
  • Any of the laboratory test indicators during screening meet the following standards (those who meet the criteria can be retested once within one week if there is a clear reason for retesting) :
  • 1) Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥3.0×ULN and/or total bilirubin ≥2.0×ULN;
  • 2) patients with renal function injury were defined as eGFR <60ml/min/1.73 m2 (calculated according to the simplified formula of dietary adjustment for renal disease (MDRD));
  • 3) Thyroid function test: abnormal thyroid stimulating hormone (TSH), serum free triiodothyronine (FT3), serum free thyroxine (FT4);
  • 4) Fasting triglyceride ≥5.64 mmol/L (500 mg/ dL);
  • 5) Blood amylase or lipase exceeded the upper limit of the normal range and was clinically significant as judged by researchers
  • Significant abnormal 12-lead electrocardiogram (ECG) results during screening, which the investigator considered might affect the safety of the subjects and are not suitable for this study;
  • Any other conditions (such as affecting the safety or efficacy evaluation of the subjects) that the investigator deemed inappropriate for the subjects to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: Efficacy and Safety of Retagliptin Phosphate in Combination With Metformin in Type 2 Diabetic Subjects With Poor Metformin Glycemic Control: a Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Design

Retagliptin phosphate tablet is a DPP IV inhibitor durg，study number is HR-SP2086-304. The primary purpose of the study is to evaluate the efficacy of the combination of Retagliptin phosphate and metformin compared with placebo and metformin in type 2 diabetes subjects with poor glycemic control treated with metformin for 16 weeks.

Conditions
Type 2 Diabetes
Being tested
Retagliptin phosphate tablets、metformin sustained-release tablets, Retagliptin phosphate placebo tablets、metformin sustained-release tablets
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.

  • Retagliptin phosphate tablets、metformin sustained-release tabletsDrug

    Retagliptin phosphate tablets 100mg+ metformin sustained-release tablets 1500mg or 2000mg based on prior medication

  • Retagliptin phosphate placebo tablets、metformin sustained-release tabletsDrug

    Retagliptin phosphate 100mg placebo tablets + metformin sustained-release tablets 1500mg or 2000mg based on prior medication

Study groups in NCT05054842
Study groupRoleWhat they receive
treatment group AExperimentalNot described
Receives: Drug: Retagliptin phosphate tablets、metformin sustained-release tablets
treatment group BPlacebo comparatorNot described
Receives: Drug: Retagliptin phosphate placebo tablets、metformin sustained-release tablets

What is being measured

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

  1. Changes in HbA1c relative to baseline

    Measured: After 16 weeks of treatment

Secondary outcomes (9)

  1. The proportion of subjects with HbA1c<6.5% and HbA1c< 7% after 16 weeks of treatment

    Measured: up to 16 weeks of treatment

  2. Changes in fasting plasma glucose relative to baseline

    Measured: up to 16 weeks of treatment

  3. Changes in 2h postprandial blood glucose relative to baseline

    Measured: up to 16 weeks of treatment

  4. Changes in body weight relative to baseline

    Measured: up to 16 weeks of treatment

  5. Percentage of subjects in each group who received remedial treatment

    Measured: up to 16 weeks of treatment]

  6. The incidence of adverse events of SP2086

    Measured: From Day 1 to Day 113

  7. The incidence of Hypoglycemic event of SP2086

    Measured: From Day 1 to Day 113

  8. Evaluate the concentrations of SP2086 in Type 2 diabetes

    Measured: up to 16 weeks of treatment

  9. Evaluate the concentration of the main metabolite of SP2086 in Type 2 diabetes

    Measured: up to 16 weeks of treatment

Timeline

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

  1. First posted23 Sep 2021
  2. Study start6 Dec 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

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
SP2086 VS. Placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054842
Sponsor's protocol ID
HR-SP2086-304
Status last verified
Jun 2023
First submitted
9 Sep 2021
Last updated
10 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retagliptin phosphate tablets、metformin sustained-release tablets in people with Type 2 Diabetes, run by Jiangsu HengRui Medicine 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 29 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?

Results are not available in the source record.

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?

Changes in HbA1c relative to baseline (time frame: After 16 weeks of treatment). 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 NCT05054842.

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 Jul 2023.

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