Calorie Restricted Dietary Intervention in Type 2 Diabetes Patients With Obesity for Remission

NCT07753447 | Completed Phase 4 DMC

• 2 other identifiers: SC25MISV00352021R1A2C2013890
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to induce remission of type 2 diabetes through dietary intervention for weight reduction.

Conditions

Diabetes, Type 2; Obesity &Amp; Overweight

Outcome Measures

Primary Outcomes (1)

• Remission

  The diabetes remission rate at Week 12 will be compared between the intervention and control groups relative to baseline. Remission of type 2 diabetes is defined, in accordance with the 2021 consensus report by American and European experts (Diabetes Care 2021;44:2438-44), as an HbA1c level of less than 6.5% at the end of the 12-week intervention, following discontinuation of all glucose-lowering medications at baseline.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (1)

• Body weight

  Assessments will be performed at baseline and week 12. For participants who consent to the extension of the study period, additional assessments will be conducted at weeks 18 and 24.

Study Arms (2)

Contrave ER + Low-calorie Meal Box + Nutritional Intervention

EXPERIMENTAL

Drug: Contrave ER Combination Product: Low-calorie Meal Box Behavioral: Nutritional Intervention

Drug: Contrave ER; Combination Product: Low-calorie meal box

Contrave ER + Conventional Nutritional Education

ACTIVE COMPARATOR

Drug: Contrave ER Behavioral: Conventional Nutritional Education

Drug: Contrave ER

Interventions

Contrave ER DRUG

Contrave is an extended-release combination of naltrexone and bupropion, approved for chronic weight management. It acts on the central nervous system to reduce appetite and control food cravings.

Contrave ER + Conventional Nutritional Education; Contrave ER + Low-calorie Meal Box + Nutritional Intervention

Low-calorie meal box COMBINATION_PRODUCT

The meal boxes provided by CJ CheilJedang are nutritionally-balanced, low-calorie HMR products developed with reduced levels of sodium, sugar, and saturated fats.

Contrave ER + Low-calorie Meal Box + Nutritional Intervention

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged ≥19 and \<60 years
• Confirmed diagnosis of type 2 diabetes
• Diagnosed with diabetes within the past 6 years
• Most recent BMI within the past 3 months ≥27 kg/m²
• Most recent HbA1c within the past 3 months \<11%
• No insulin therapy within the past 3 months

You may not qualify if:

• Pregnant women or those who may become pregnant during the study period
• Individuals with organ failure, such as heart failure, hepatic failure, renal failure, or chronic obstructive pulmonary disease
• History of cardiovascular disease or cancer treatment within the past 6 months
• Acute illness requiring hospitalization (e.g., infection or surgery) within the past 3 months
• Presence of endocrine disorders that may affect body weight, such as Cushing's syndrome
• Use of medications (other than glucose-lowering agents for diabetes) known to affect blood glucose levels within the past 6 months
• Individuals with known food allergies to specific ingredients in the study meals
• Individuals with uncontrolled hypertension
• Individuals with acute alcohol or drug withdrawal symptoms
• History of seizure disorders such as epilepsy
• Individuals with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption

Sponsors & Collaborators

• Yeouido St. Mary's Hospital: lead
• HK inno.N Corporation: collaborator
• Handok Inc.: collaborator
• Kwang Dong Pharmaceutical co., ltd.: collaborator

Study Sites (1)

Yeouido Saint Mary's Hospital

Seoul, 07345, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hyuk-Sang Kwon, MD, PhD

  The Catholic University of Korea, College of Medicine

  PRINCIPAL INVESTIGATOR

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: July 31, 2025
• First Posted: August 7, 2026
• Study Start: July 1, 2025
• Primary Completion: January 27, 2026
• Study Completion: February 28, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)