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Type2 Diabetes MellitusPhase 3NCT03239119

The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

A Phase 3 study testing rE-4 5 mcg and rE-4 10 mcg in people with Type2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type2 Diabetes Mellitus
What is being tested?
rE-4 5 mcg and rE-4 10 mcg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
456 participants
Where
No sites listed yet
Study dates
30 Nov 2017to 15 Jan 2019
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

  • T2DM
  • 7.0% ≤ HbA1c ≤ 11.0% at screening
  • FPG ≤13.8 mmol/L
  • 19 kg/m2 < BMI <35.0 kg/m2 at screening
  • All subjects provided written informed consent before participation

Who cannot join

  • T1DM
  • Patients treated previously with Exenatide or GLP-1 similar
  • At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
  • At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
  • Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
  • Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
Show all 15Show fewer
  • History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
  • Patients with severe renal impairment or end-stage renal disease
  • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
  • Use of weight loss drugs within 3 months prior to screening visit
  • Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
  • Severe gastrointestinal disease (e.g., gastroparesis)
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
  • Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
  • History of severe hypersensitivity to rExenatide-4 or any product components

Trial locations and contacts

No sites are listed yet.

linong Ji, Ph.D contact

+86-01088325578

jiln@bjmu.edu.cn

About this study

Official title: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) and Safety of rE-4 in Subjects With Type 2 Diabetes Mellitus Treated With Metformin, a Sulfonylurea, or Metformin and Sulfonylurea Combination

This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.

Read the detailed description

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.

Being tested
rE-4 5 mcg, rE-4 10 mcg, Placebo 5 mcg, Placebo 10 mcg
Keywords
rE-4, Exenatide, Metformin, Sulfonylurea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rE-4 5 mcgBiological

    Also called rExenatide-4

    Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily

  • rE-4 10 mcgBiological

    Also called rExenatide-4

    Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily

  • Placebo 5 mcgBiological

    Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily

  • Placebo 10 mcgBiological

    Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily

Study groups in NCT03239119
Study groupRoleWhat they receive
rE-4 5 mcgExperimentalPlacebo, then rE-4 5 mcg, then rE-4 5 mcg
Receives: Biological: rE-4 5 mcg
rE-4 10 mcgExperimentalPlacebo, then rE-4 5 mcg, then rE-4 10 mcg
Receives: Biological: rE-4 10 mcg
Placebo 5 mcgPlacebo comparatorPlacebo 5 mcg, then Placebo 5 mcg, then Placebo 5 mcg
Receives: Biological: Placebo 5 mcg
Placebo 10 mcgPlacebo comparatorPlacebo 5 mcg, then Placebo 5 mcg, then Placebo 10 mcg
Receives: Biological: Placebo 10 mcg

What is being measured

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

  1. Change in HbA1c from Baseline to Week 30

    Change in HbA1c from Baseline (Day 1) to study termination (Week 30)

    Measured: Baseline (Day 1) to Week 30

Secondary outcomes (4)

  1. The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by Week 30

    The number of subjects achieving HbA1c target values of < 7% and ≤ 6.5% by study termination (Week 30)

    Measured: Baseline (Day 1) and Week 30

  2. Change in body weight from Baseline to each intermediate visit and Week 30

    Change in body weight (kg) from Baseline to each intermediate visit and Week 30

    Measured: Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30

  3. Change in FPG from Baseline to each intermediate visit and Week 30

    Change in Fasting Plasma Glucose from Baseline to each intermediate visit and Week 30

    Measured: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30

  4. Change in 7-SMBG from Baseline to Week 16，Week 24 and Week 30

    Change in glucose measurements before and 2h after the start of the morning,midday,and evening meals, and at bedtime from Baseline to Week 16，Week 24 and Week 30

    Measured: Baseline, Week 16，Week 24 and Week 30

Timeline

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

  1. First posted3 Aug 2017
  2. Study start30 Nov 2017 (estimated)
  3. Primary completion30 Dec 2018 (estimated)
  4. Study completion15 Jan 2019 (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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03239119
Sponsor's protocol ID
rE-4201706/PRO
Status last verified
Jul 2017
First submitted
1 Aug 2017
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rE-4 5 mcg and rE-4 10 mcg in people with Type2 Diabetes Mellitus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 15 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 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact linong Ji, Ph.D (+86-01088325578, jiln@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c from Baseline to Week 30 (time frame: Baseline (Day 1) to Week 30). 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 NCT03239119.

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 3 Aug 2017.

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