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Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Newly Diagnosed Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03987308
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Hospital

Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date June 17, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
The percentage of patients with at least a 0.7% change in the absolute value of glycated hemoglobin [ Time Frame: Baseline and week5 ]
The primary endpoint of the trial is a composite endpoint reflected by the percentage of patients with at least a 0.7% change in the absolute value of glycated hemoglobin and without hypoglycemia after 5 weeks of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • After five weeks of treatment, the differences in the percentages of patients with at least 3% weight loss [ Time Frame: Baseline and week5 ]
    After five weeks of treatment, the differences in the percentages of patients with at least 3% weight loss (compared to their baseline weights) in the two treatment groups
  • The percentage of subjects whose blood glucose levels are within the normal range [ Time Frame: Baseline and week5 ]
    The percentage of subjects whose blood glucose levels are within the normal range after five weeks of treatment
  • The time required for patients' blood glucose levels to reach the normal range [ Time Frame: Baseline and week5 ]
    The time (days) required for patients' blood glucose levels to reach the normal range during the five-week treatment
  • Body weights of the two patient groups [ Time Frame: Baseline and week5 ]
    Body weights of the two patient groups after the five-week treatment
  • Waist circumferences of the two patient groups [ Time Frame: Baseline and week5 ]
    Waist circumferences of the two patient groups after the five-week treatment
  • BMIs of the two patient groups [ Time Frame: Baseline and week5 ]
    BMIs of the two patient groups after the five-week treatment
  • Waist-to-hip ratios (WHRs) of the two patient groups [ Time Frame: Baseline and week5 ]
    Waist-to-hip ratios (WHRs) of the two patient groups after the five-week treatment
  • Changes in the function of islet β-cells (HOMA-β) [ Time Frame: Baseline and week5 ]
    Changes in the functions of islet β-cells in patients after five weeks of treatment (measured by the Homeostatic Model Assessment of β-cell function HOMA-β)
  • Changes in the function of islet β-cells (insulin index ΔI30 / ΔG30) [ Time Frame: Baseline and week5 ]
    Changes in the functions of islet β-cells in patients after five weeks of treatment (measured by insulin index ΔI30 / ΔG30);
  • Changes in insulin sensitivity [ Time Frame: Baseline and week5 ]
    Changes in insulin sensitivity in the two patient groups after five weeks of treatment (measured by the Homeostatic Model Assessment of Insulin Resistance - HOMA-IR).
  • Changes in β-cell function (HOMA-β) [ Time Frame: Baseline and week53 ]
    After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: HOMA-β changes at week 53 from baseline
  • Weight changes between the two treatment groups [ Time Frame: Baseline and week53 ]
    After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: weight changes at week 53 from baseline
  • Weight changes between the two treatment groups [ Time Frame: week5 and week53 ]
    After 53 weeks, the following indices for responders who meet the HbA1c criteria will be compared between the two treatment groups: weight changes at week 53 from week 5
  • The percentage of responders who meet the HbA1c criteria [ Time Frame: Baseline and week53 ]
    The percentage of responders who meet the HbA1c criteria at week 53 will be compared between the Beinaglutide-treated group and the insulin aspart-treated group
  • The differences in the duration of target blood glucose levels that are met [ Time Frame: Baseline and week53 ]
    The difference in the duration during which the criteria of blood glucose levels are met will be compared
  • The percentages of responders who meet the HbAc1 criteria [ Time Frame: week5 and week17 ]
    The percentages of responders who meet the HbAc1 criteria at week 17 from the end of treatments will be compared
  • Weight changes between the two treatment groups [ Time Frame: week5 and week17 ]
    The percentages of responders who meet the weight changes at week 17 from the end of treatments will be compared
  • Differences in HbA1c indices [ Time Frame: Week5 and week29 ]
    Analyze the differences in HbA1c indices for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria after 5-week treatment, respectively
  • Differences in weight [ Time Frame: Week5 and week29 ]
    Analyze the differences in weight for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria after 5-week treatment, respectively
  • Differences in HbA1c indices [ Time Frame: Week5 and week53 ]
    Analyze the differences in HbA1c indices for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively
  • Differences in weight [ Time Frame: Week5 and week53 ]
    Analyze the differences in weight for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively
  • Differences in insulin levels [ Time Frame: Week5 and week53 ]
    Analyze the differences in insulin for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively
  • Differences in C-peptide levels [ Time Frame: Week5 and week53 ]
    Analyze the differences in C-peptide for responders who meet the HbA1c criteria and non-responders who failed the HbA1c criteria at week 53, respectively
  • The percentages of subjects with greater than 3% weight loss [ Time Frame: Baseline and week53 ]
    The percentages of subjects with weight loss at week 53 from baseline greater than 3% will be compared between the two treatment groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Newly Diagnosed Type 2 Diabetes
Official Title  ICMJE Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
Brief Summary The efficacy, safety and post-treatment disease control will be compared between treatments consisting of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
Detailed Description

Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during basic meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment.

This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:

a five-week treatment phase and a 48-week post-treatment follow-up period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetic Patients
Intervention  ICMJE
  • Drug: Beinaglutide
    Five-week Beinaglutide pump treatment group
  • Drug: Insulin aspart
    Five-week short-term CSII (insulin aspart) treatment group
Study Arms  ICMJE
  • Experimental: Beinaglutide
    Five-week Beinaglutide pump treatment group
    Intervention: Drug: Beinaglutide
  • Experimental: Insulin aspart
    Five-week short-term CSII (insulin aspart) treatment group
    Intervention: Drug: Insulin aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 18 to 70 years (including 18- and 70-year-olds) at the time of enrollment regardless of gender;
  • Patients who are willing to sign the informed consent form voluntarily;
  • Patients diagnosed with type 2 diabetes based on the WHO 1999 diagnostic criteria with a disease duration of < 1 year;
  • Patients with HbA1c levels between 9% and 12.0% or fasting blood glucose levels greater than 11.1 mmol / L;
  • Patients with BMIs between 24 and 45 kg / m2;
  • Patients who have not taken or have taken hypoglycemic agents for less than a month or patients who are not receiving any ongoing systematic treatment with oral hypoglycemic drugs (have taken hypoglycemic drugs for less than three months in the past but have stopped taking drugs more than three months earlier);
  • Fertile female patients (or male subjects with fertile female partners) who agree to use effective contraceptives throughout the course of the study until one full month after the last treatment dosage.

Exclusion Criteria:

  • Patients with type 1 or other types of diabetes;
  • Patients with a history of obstructive bowel disease or such possible complications; patients with intestinal adhesions or obstructions caused by abdominal surgery or peritoneal infection; patients with reduced intestinal motilities or habitual constipation or patients with histories of immunologically based inflammatory bowel disease (IBD), Crohn's disease (CD) or ulcerative colitis (UC);
  • Past diagnosis of pancreatitis;
  • Family history of medullary thyroid carcinoma;
  • Patients with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels that are greater than 3 times the normal upper limit and/or bilirubin levels greater than 2 times the normal upper limit;
  • Patients with an above-moderate degree of renal insufficiency (eGFR < 60 ml / min / 1.73 m2);
  • Triglyceride levels ≥ 5.0 mmol / L;
  • Multiple endocrine neoplasia 2 (MEN 2);
  • Patients who have participated in a pre-market trial drug within the last three months;
  • Patients receiving treatments with systemic hormones (including glucocorticoids), immunosuppressants or cytotoxic drugs or who are anticipating such treatments during the course of the study;
  • Patients with severe ketosis or ketoacidosis less than one month prior to screening;
  • Patients with blood pressure above the following values (untreated or after treatments): systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg;
  • Within three months before the screening visit, patients have suffered one of following cardiovascular illnesses: acute myocardial infarction or congestive heart failure (cardiac functional capacity III/IV based on the New York Heart Association criteria or left ventricular ejection fraction ≤ 40%) or patients who have experienced cerebrovascular incidents (stroke);
  • Patients with inflammatory bowel disease;
  • Patients who are allergic to the test drug (Beinaglutide) or any of its other components and those who are allergic to the insulin reagent used in the study or any of its ingredients;
  • Patients who have certain serious diseases that may interfere with the study and are not suitable to participate, as determined by the investigators;
  • Pregnant women or women who are breastfeeding;
  • Patients whose compliance is considered poor by the investigators, such that the study cannot be completed as required;
  • Patients who are not suitable candidates to receive continuous pumping, such as those who are allergic to subcutaneous infusion tubes or tapes; those who are not willing to allow subcutaneous embedment of infusion tubes or to wear pumps for a long period of time; those who do not wish to receive medication via a pump; those who fail to master correct use after training sessions due to a lack of appropriate knowledge of the patients themselves or their family members; those with severe psychological or mental disorders or those who, without any guardians, are not capable of taking care of themselves;
  • Patients who are not eligible to participate in this study due to factors identified by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lixin Guo, Ph.D, M.D. 13901317569 glx1218@163.com
Contact: Yan Zhou, Ph.D, M.D. 13693033121 1430161933@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03987308
Other Study ID Numbers  ICMJE BN-IIT-IS-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Hospital
Study Sponsor  ICMJE Beijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP