Current partner codePEPTIDESDE
NCT05606913·Phase 3·INTERVENTIONAL

A Study of IBI362 in Participants With Type 2 Diabetes

Status

Completed

Phase

Phase 3

Enrollment

731

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.

Interventions

Treatment arms and agents.

DRUG

dulaglutide

Dulaglutide administered subcutaneously (SC) once a week.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Timeline

From registration to results.

  1. First posted

    Nov 7, 2022

  2. Study start

    Jan 6, 2023

  3. Primary completion

    Jan 26, 2024

  4. Study completion

    Apr 9, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 23, 2024

Outcomes

What the study measures.

Primary outcomes

HbA1c change from baseline at week 28

Time frame · Baseline, 28 weeks

Secondary outcomes

percent change from baseline in body weigh

Time frame · Baseline, 28 weeks

Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline

Time frame · Baseline, 28 weeks

Change from baseline in HbA1c (superiority)

Time frame · Baseline, 28 weeks

Proportion of subjects with HbA1c <7.0%

Time frame · Baseline, 28 weeks

Safety,Incidence and severity of adverse events and correlation with study drug;

Time frame · Baseline to 32weeks

Time to peak plasma concentration (Tmax)

Time frame · Baseline to 28weeks

Time to peak plasma concentration (Cmax)

Time frame · Baseline to 28weeks

area under curve (AUC)

Time frame · Baseline to 28weeks

volume distribution (V)

Time frame · Baseline to 28weeks

half-life (half-life, T1/2

Time frame · Baseline to 28weeks

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. T2D was diagnosed according to WHO standards in 1999 for 2. Age ≥ 18 when signing the informed consent form 3. After used stable-dose metformin (≥1500 mg/day) or stable-dose metformin (≥1500 mg/day) combined with SGLT2 inhibitors (empagliflozin 10 mg/day, dapagliflozin 10 mg/day, canagliflozin 100 mg/day, Henagliflozin 5 mg/day) for 2 months before screening, or stable-dose metformin (≥1500 mg/day) combined with daily fixed-dose sulfonylureas (half the maximum dose on the drug label), the blood sugar was still poorly controlled, the local laboratory test at the time of screening was 7.5%≤HbA1c≤11.0%. 4. BMI≥23 kg/m2 at screening. 5. Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol Exclusion Criteria: 1. Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs 2. Weight change\>5% within 12 weeks before screening (chief complaint) 3. Oral hypoglycemic drugs other than background therapy drugs have been used within 2 months before screening. 4. Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes 5. There are active or untreated malignant tumors within 5 years before screening, or patients are in remission of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery) 6. Mental illness existed in the past or at the time of screening, and the researcher thinks it is not suitable to participate in this study 7. Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period 8. The investigator believes that the subject has any other factors that may affect the efficacy or safety evaluation of this study and is not suitable to participate in this study

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

China-Japan Friendship Hospital

Beijing, Beijin, China

Related trials

More studies on Mazdutide.

Related PeptideStat pages

Put the record in context.

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