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NCT05628311·Phase 3·INTERVENTIONAL

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Status

Completed

Phase

Phase 3

Enrollment

319

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control. The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c\<8.5% or HbA1c ≥ 8.5% before randomization.

Interventions

Treatment arms and agents.

OTHER

placebo

placebo administered subcutaneously (SC) once a week.

DRUG

IBI362

IBI362 administered subcutaneously (SC) once a week.

Timeline

From registration to results.

  1. First posted

    Nov 28, 2022

  2. Study start

    Jan 6, 2023

  3. Primary completion

    Oct 25, 2023

  4. Study completion

    May 9, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Aug 20, 2024

Outcomes

What the study measures.

Primary outcomes

HbA1c change from baseline at week 24

Time frame · Baseline, 24 weeks

Secondary outcomes

Proportion of subjects with HbA1c<7.0% at week 24

Time frame · Baseline, 24 weeks

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

Time frame · Baseline to 52 weeks

Time to peak plasma concentration (Tmax)

Time frame · Baseline to 52 weeks

Time to peak plasma concentration (Cmax)

Time frame · Baseline to 52 weeks

area under curve (AUC)

Time frame · Baseline to 52 weeks

volume distribution (V)

Time frame · Baseline to 52 weeks

half-life (half-life, T1/2)

Time frame · Baseline to 52 weeks

clearance rate (clearance, CL)

Time frame · Baseline to 52 weeks

To assess changes in PD parameters fasting insulin at different time points before and after administration.

Time frame · Baseline to 52 weeks

To assess changes in PD parameters fasting C-peptide at different time points before and after administration.

Time frame · Baseline to 52 weeks

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 at least 2 months 2. Age ≥ 18 when signing the informed consent form 3. The blood glucose was not well controlled after simple diet and exercise within 2 months before screening, and the local laboratory tested 7.5% ≤ HbA1c ≤ 10.5% during screening 4. Maintain a stable diet and exercise lifestyle during the study 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. Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 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.

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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