The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

NCT07272343 | Recruiting Phase 4 DMC

• 1 other identifier: 2022efyA04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.

Conditions

Type 2 Diabetes Mellitus (T2DM); Semaglutide; Caloric Restriction

Keywords

Type 2 Diabetes Mellitus; semaglutide; Caloric Restriction

Outcome Measures

Primary Outcomes (3)

• HbA1c

  glycated hemoglobin

  From enrollment to the end of treatment at 12 weeks

• FPG

  fasting plasma glucose

  From enrollment to the end of treatment at 12 weeks

• 2hPG

  2-hour postprandial glucose

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• HOMA-IR

  From enrollment to the end of treatment at 12 weeks

• TC

  From enrollment to the end of treatment at 12 weeks

• TG

  From enrollment to the end of treatment at 12 weeks

• LDL-C

  From enrollment to the end of treatment at 12 weeks

• HDL-C

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

semaglutide group

EXPERIMENTAL

The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12).

Drug: semaglutide

caloric restriction group

ACTIVE COMPARATOR

The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).

Behavioral: caloric restriction

Interventions

semaglutide DRUG

The semaglutide group received weekly subcutaneous semaglutide (0.25 mg for weeks 1-2, 0.5 mg for weeks 3-4, and 1.0 mg for weeks 5-12).

semaglutide group

caloric restriction BEHAVIORAL

The caloric restriction group followed a gender-specific daily caloric restriction (1,500-1,800 kcal for males; 1,200-1,500 kcal for females).

caloric restriction group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years;
• BMI≥25 kg/m²;
• Diagnosed as type 2 diabetes mellitus patients according to the "Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 Edition)";
• HbA1c≤8.5%;
• Duration of diabetes ≤3 months, and no use of antihyperglycemic drugs;
• Willing to participate in this study, and after full informed consent, agrees to strictly follow the treatment plan and promises to attend follow-up visits on time, and signs the informed consent form.

You may not qualify if:

• BMI \< 25 kg/m²;
• Age \< 18 years, or \> 75 years;
• History of type 1 diabetes, acute pancreatitis, or diabetes secondary to pancreatectomy;
• History of bariatric surgery or planned bariatric surgery, or currently attempting weight loss within the past 3 months, or use of weight-loss medications within the past 3 months;
• Use of GLP-1 receptor agonists, sodium-glucose cotransporter 2 inhibitors, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, or other related drugs within the past 3 months;
• Pregnant or breastfeeding women, or those planning to conceive during the study period;
• Patients with severe diseases of important organ systems, such as severe cardiovascular and cerebrovascular diseases, respiratory diseases, gastrointestinal diseases, renal insufficiency, hematologic diseases, neurological diseases, or malignancies;
• Personal or family history of medullary thyroid carcinoma;
• Patients with severe mental disorders or communication barriers that prevent accurate understanding of the study content and compliance with the trial procedures.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

Minde road No.1

Jiangxi, Nanchang, 330000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide; Caloric Restriction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Jianping Liu

CONTACT

+8679186274551; ndefy14105@ncu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 9, 2025
• Study Start: February 10, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)