A Phase 4 interventional study of Lifestyle therapy and Pharmacotherapy in Diabetes Mellitus, Type 2, sponsored by Shandong Provincial Hospital. Status unknown at 2 sites in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-09.
Sponsored by Shandong Provincial Hospital · Phase 4, Interventional, and Treatment
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Among 909 studies in Diabetes Mellitus, Type 2 with a site in China — 205 open to participants now, 228 under way, 46 of them phase 3. Diabetes Mellitus, Type 2 · China.
Among the 909 studies in Diabetes Mellitus, Type 2 with a site in China, this one is the 24th largest by planned enrollment of the 767 interventional ones that give a count, is one of 34 that started in 2018, is one of 155 in phase 4, and was the 318th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →205 of the 909 studies in Diabetes Mellitus, Type 2 with a site in China are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in China, United States, Brazil and 7 more countries
Ages 18+
BrightGene Bio-Medical Technology Co., Ltd. · Sites in China
Ages 18–75
Fujian Shengdi Pharmaceutical Co., Ltd. · Sites in China
Ages 18–65 · Healthy volunteers
The United Bio-Technology (Hengqin) Co., Ltd. · Sites in China
Ages 18–75
The United Bio-Technology (Hengqin) Co., Ltd. · Sites in China
Ages 18–75
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 35 Years to 75 Years · all sexes · no healthy volunteers.
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909 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 142 · Phase 2 90 · Phase 3 216 · Phase 4 155
First in 1998; this study’s year is marked. 34 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 6,300 is above the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 199 across the 767 interventional studies, 593 across the 141 observational. Of the 518 that completed or were terminated, 123 (24%) have results posted.
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448 of 909 have an industry lead sponsor. The 10 most frequent:
Shandong Provincial Hospital is the lead sponsor of 62 studies on the registry; 24 are open to participants now.
Shandong Provincial Hospital has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
54 of the studies in Diabetes Mellitus, Type 2 with a site in China that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07060456Phase 3Fujian Shengdi Pharmaceutical Co., Ltd.Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin | 2027-02 |
| NCT07082114Phase 3Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus | 2027-02-16 |
| NCT07156500Phase 3Jiangsu Hansoh Pharmaceutical Co., Ltd.A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone | 2027-03-30 |
| NCT07156539Phase 3Jiangsu Hansoh Pharmaceutical Co., Ltd.A Phase 3 Study of HS-20094 in Patients With T2DM | 2027-03-30 |
| NCT06993792Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes | 2027-08 |
Add all 54 to your calendar (.ics) → With an account.
Among the 909 studies in Diabetes Mellitus, Type 2 with a site in China, from their registry updates:
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The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Lifestyle therapy · Drug: Pharmacotherapy · Other: Monitoring and management
Other: General treatment
The key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products.
Pharmacological therapy is individualized. 1.Glucose-lowering agents: 1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors 2. GLP-1 receptor agonist 3. Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products 2.Blood pressure-lowering agents (1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers 3.Lipid-modifying agents (1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc. 4.Medications for weight management (1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels.
Before follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification.
General treatment is carried out based on the device from the general practitioners at present.
Integrated management rate of multiple risk factor in type 2 diabetes
Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity
Time frame: 30 months
Incidence of diabetic vascular complications
Diabetic vascular complications: both macrovascular and microvascular complications
Time frame: 30 months
Control rate of diabetes and diabetic vascular complications
Time frame: 30 months
Carotid intima-media thickness (IMT)
Time frame: 30 months
Ankle brachial index (ABI)
Time frame: 30 months
Urine albumin creatinine ratio (UACR)
Time frame: 30 months
Estimated glomerular filtration rate (eGFR)
Time frame: 30 months
Stage of diabetic retinopathy evaluated by fundus photograph
Time frame: 30 months
Started Apr 2018 (actual). Primary completion is estimated for Dec 2021, 44 months after the start.
Of 320 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 49. This study's planned 44 months is above that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Shandong Provincial Hospital