Efficacy of Metformin in Preventing Diabetes in China

NCT03441750 | Completed Phase 4

• 1 other identifier: ChineseAGR
• Study Type: interventional
• Target: 1,724
• Locations: 1 country
• Sites: 1

Brief Summary

A multicentred, randomized, open study to evaluate the efficacy of metformin in preventing Diabetes.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Rate of newly diagnosed diabetes

  The primary outcome will be evaluated when the last subject completes 2 years' intervention.

Study Arms (2)

metformin plus standard lifestyle intervention

EXPERIMENTAL

Metformin starting dose is 850mg/d, it will be titrated to 850mg twice daily after 2 weeks and maintained until the last subject completes 2 years' intervention.

Drug: metformin

Standard lifestyle intervention

OTHER

Standard lifestyle advice will be united for all subjects by providing special booklet.

Other: Standard lifestyle intervention

Interventions

metformin DRUG

Metformin tablets will be administrated in the experimental arm.

Also known as: Glucophage immediate release formulation

metformin plus standard lifestyle intervention

Standard lifestyle intervention OTHER

Standard lifestyle advice will be united for all subjects by providing special booklet. * All participants will receive 20-30 minutes individual or group session with assigned nurse addressing the harm of prediabetes and the importance of a healthy lifestyle for preventing Diabetes. * The amount of energy intake of the participants will be calculated based on the ideal body weight and physical activity levels. The sample recipe will be explained by the nurse and provided in the diet instruction. * Moderate intensity physical activity (150 minutes per week) is recommended. * Smoking cessation is encouraged for the smoker. * Excessive alcohol intake is encouraged to avoid.

Standard lifestyle intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of IGR before the randomization based on the 1999 WHO diagnostic and classification criteria.
• Age: 18 ≤age≤70 years old.
• Not on a treatment of anti-diabetic agents, including Chinese traditional herbs lowering blood glucose for at least 6 months before screening.
• Male or non-pregnant, non-breastfeeding females, females without birthing plan in next three years.
• Body mass index (BMI) ：21 kg/m2 ≤BMI\<32 kg/m2.
• Written informed consent given before any trial-related activities are carried out.

You may not qualify if:

• Administration with medications for pre-existed diseases affect glucose metabolism (except thiazide diuretics when its daily dose≤12.5mg).
• Administration with anti-obesity agents (including Chinese traditional medicine) within 6 months of enrolment and during intervention.
• Administration with three or more than three types antihypertensive drugs.
• Diabetes patients (subjects with prior history of gestational Diabetes will not be excluded).
• Have any of the following cardiovascular conditions within 3 months prior to the screening visit: acute myocardial infarction, congestive heart failure defined as New York Heart Association class III/IV or left ventricular ejection fraction ≤40%,) or cerebrovascular accident.
• Persistent uncontrolled hypertension (systolic blood pressure ≥160mmHg, or diastolic blood pressure ≥100 mmHg).
• Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT or AST levels ≥3 times the upper limit of the reference range at the screening visit.
• Renal dysfunction (eGFR\<45ml/min）.
• Patients ventilated by ventilator.
• Hypersensitivity to metformin or to any of the excipients such as povidone K 30, magnesium stearate and hypromellose.
• Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).
• Acute alcohol intoxication, alcoholism.
• Severe chronic gastrointestinal disease.
• Severe psychiatric illness.
• Cancer requiring treatment in past 5 years.

Sponsors & Collaborators

• Chinese Association of Geriatric Research: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Related Publications (2)

• Zhang L, Zhang Y, Shen S, Wang X, Dong L, Li Q, Ren W, Li Y, Bai J, Gong Q, Kuang H, Qi L, Lu Q, Cheng W, Liu Y, Yan S, Wu D, Fang H, Hou F, Wang Y, Yang Z, Lian X, Du J, Sun N, Ji L, Li G; China Diabetes Prevention Program Study Group. Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Aug;11(8):567-577. doi: 10.1016/S2213-8587(23)00132-8. Epub 2023 Jul 3.

  PMID: 37414069 DERIVED

• Ji L, Sun N, Zhang Y, Zhang L, Shen S, Wang X, Li Q, Dong L, Ren W, Qi L, Li Y, Yan S, Cheng W, Kuang H, Li G. Efficacy of metformin in preventing progression to diabetes in a Chinese population with impaired glucose regulation: Protocol for a multicentre, open-label, randomized controlled clinical study. Diabetes Obes Metab. 2020 Feb;22(2):158-166. doi: 10.1111/dom.13884. Epub 2019 Oct 24.

  PMID: 31512365 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Guangwei Li, M.D., Ph.D.

  Chinese Association of Geriatric Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: April 25, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

CN (1)