NCT05628311CompletedPhase 3
A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 319 (actual)
- First submitted
- 17 Nov 2022
- Start date
- 6 Jan 2023
- Primary completion date
- 25 Oct 2023
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT05628311
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 319
- From 6 Jan 2023 to the primary completion date, 25 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Weight change\>5% within 12 weeks before screening (chief complaint)
- Used any oral hypoglycemic drugs within 2 months before screening; ≥ 3 oral hypoglycemic drugs have been used together more than 2 months before screening
- Previous diagnosis of type 1 diabetes (including adult latent autoimmune diabetes), special type diabetes or gestational diabetes
Other illness
- Subjects who the investigator thinks may be allergic to the components in the study drug or similar drugs
- 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)
- 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
Other
- Pregnant or lactating women, or men or women who are fertile and unwilling to use contraception throughout the study period
- 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
Who the study is looking for
- T2D was diagnosed according to WHO standards in 1999 for at least 2 months
- Age ≥ 18 when signing the informed consent form
- 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
- Maintain a stable diet and exercise lifestyle during the study
- Subjects voluntarily signed the informed consent form and agreed to strictly follow the requirements of this protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.