Efficacy of Metformin in Preventing Diabetes in China (ChinaDPP)

A Multicentre, Open-labelled, Randomized, Controlled Study to Evaluate the Efficacy of Metformin in Preventing Diabetes in China.

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

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Drug: metformin; Other: Standard lifestyle intervention

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 Type: Interventional
• Enrollment (Actual): 1724
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of newly diagnosed diabetes	The primary outcome will be evaluated when the last subject completes 2 years' intervention.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: ChineseAGR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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