A Study of Supaglutide in Chinese Type 2 Diabetes Patients

September 16, 2021 updated by: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.

A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • The Affiliated Zhongda Hospital of Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
  2. Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
  3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
  4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m^2).

Exclusion Criteria:

  1. Type 1 diabetes (T1D).
  2. Evidences of fasting C-peptide levels<0.81 ng/mL.
  3. History of trauma, infection or surgery within a month;
  4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
  5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
  6. Evidence of abnormal thyroid function within 6 months before screening.
  7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
  8. History of serious mental illness.
  9. History of drug or alcohol abuse.
  10. History of a transplanted organ, acquired or congenital immune system diseases.
  11. Allergy to active ingredients or excipients of the test drug.
  12. Evidence of abnormal result of laboratory examination according to the judgment of researchers.
  13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
  14. Previously completed or withdrawn from this study after providing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supaglutide (Part A)
Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
Drug: Supaglutide
Administered SC
Other Names:
  • Diabegone
Placebo Comparator: Placebo(Part A)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Drug: Placebo
Administered SC
Experimental: Supaglutide (Part B)
Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
Drug: Supaglutide
Administered SC
Other Names:
  • Diabegone
Placebo Comparator: Placebo (Part B)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline, 7 weeks, 17weeks
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, 7 weeks, 17weeks
Adverse Events
Time Frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Number of Adverse Events
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Vital Sign
Time Frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Vital Sign
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Laboratory Tests
Time Frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Laboratory Tests
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
12-lead ECGs
Time Frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of 12-lead ECGs
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Immunogenicity Tests
Time Frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Immunogenicity Tests
Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1c <7%
Time Frame: Baseline, 7 weeks, 17weeks
Percentage of Participants Achieving HbA1c Target <7.0%
Baseline, 7 weeks, 17weeks
Glycosylated Albumin
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Glycosylated Albumin
Baseline, 7 weeks, 17weeks
Fasting Blood Glucose
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood Glucose
Baseline, 7 weeks, 17weeks
Fasting Blood Insulin
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood Insulin
Baseline, 7 weeks, 17weeks
Fasting Blood C-peptide
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Fasting Blood C-peptide
Baseline, 7 weeks, 17weeks
Blood Lipid
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Blood Lipid
Baseline, 7 weeks, 17weeks
Body Weight
Time Frame: Baseline, 7 weeks, 17weeks
Changes from Baseline in Body Weight
Baseline, 7 weeks, 17weeks
Pharmacokinetics (PK): Area Under the Curve
Time Frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞)
Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Pharmacokinetics (PK): t½ of Supaglutide
Time Frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
Terminal Elimination Half-life in Plasma (t½)
Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
PK: Tmax of Supaglutide
Time Frame: Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
Time to Maximum Plasma Concentration (Tmax)
Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai 6th People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weiping Jia, Doctor, Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital
  • Principal Investigator: Yuqian Bao, Doctor, Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YN011B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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