ChinaDPP: Efficacy of Metformin in Preventing Diabetes in China

Sponsor
Chinese Association of Geriatric Research (Other)
Overall Status
Completed
CT.gov ID
NCT03441750
Collaborator
(none)
1,724
1
2
50.2
34.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The increasing prevalence of prediabetes had been documented in the recent national surveillance in China. Prediabetes is an important risk factor for developing overt Diabetes and macro/micro vascular diseases. Pharmaceutical medications such as metformin had been proved effective in preventing Diabetes. Local studies are in need to guide the clinicians in their daily practice to prevent Diabetes in China. Therefore, China Diabetes Prevention Program(China DPP)is designed and conducted to compare the efficacy of metformin combined with lifestyle intervention versus lifestyle intervention alone in preventing Diabetes.

Study Design

Study Type:
Interventional
Actual Enrollment :
1724 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Multicentre, Open-labelled, Randomized, Controlled Study to Evaluate the Efficacy of Metformin in Preventing Diabetes in China.
Actual Study Start Date :
Apr 25, 2017
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: metformin plus standard lifestyle intervention

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
Metformin tablets will be administrated in the experimental arm.
Other Names:
  • Glucophage immediate release formulation
  • Other: Standard lifestyle intervention

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

    Other: Standard lifestyle intervention
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of newly diagnosed diabetes [The primary outcome will be evaluated when the last subject completes 2 years' intervention.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Main Inclusion Criteria:
    1. Diagnosis of IGR before the randomization based on the 1999 WHO diagnostic and classification criteria.

    2. Age: 18 ≤age≤70 years old.

    3. Not on a treatment of anti-diabetic agents, including Chinese traditional herbs lowering blood glucose for at least 6 months before screening.

    4. Male or non-pregnant, non-breastfeeding females, females without birthing plan in next three years.

    5. Body mass index (BMI) :21 kg/m2 ≤BMI<32 kg/m2.

    6. Written informed consent given before any trial-related activities are carried out.

    Main exclusion Criteria:
    1. Administration with medications for pre-existed diseases affect glucose metabolism (except thiazide diuretics when its daily dose≤12.5mg).

    2. Administration with anti-obesity agents (including Chinese traditional medicine) within 6 months of enrolment and during intervention.

    3. Administration with three or more than three types antihypertensive drugs.

    4. Diabetes patients (subjects with prior history of gestational Diabetes will not be excluded).

    5. 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.

    6. Persistent uncontrolled hypertension (systolic blood pressure ≥160mmHg, or diastolic blood pressure ≥100 mmHg).

    7. 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.

    8. Renal dysfunction (eGFR<45ml/min).

    9. Patients ventilated by ventilator.

    10. Hypersensitivity to metformin or to any of the excipients such as povidone K 30, magnesium stearate and hypromellose.

    11. Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).

    12. Acute alcohol intoxication, alcoholism.

    13. Severe chronic gastrointestinal disease.

    14. Severe psychiatric illness.

    15. Cancer requiring treatment in past 5 years.

    16. Uncontrolled thyroid diseases.

    17. Women who are pregnant or breastfeeding .

    18. Participation in another clinical trial within the past 30 days .

    19. Other significant disease that in the Investigator's opinion would exclude the subject from the trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000

    Sponsors and Collaborators

    • Chinese Association of Geriatric Research

    Investigators

    • Principal Investigator: Guangwei Li, M.D., Ph.D., Chinese Association of Geriatric Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chinese Association of Geriatric Research
    ClinicalTrials.gov Identifier:
    NCT03441750
    Other Study ID Numbers:
    • ChineseAGR
    First Posted:
    Feb 22, 2018
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021