Clinical trial NCT03441750: Efficacy of Metformin in Preventing Diabetes in China
Official title: A Multicentre, Open-labelled, Randomized, Controlled Study to Evaluate the Efficacy of Metformin in Preventing Diabetes in China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PreDiabetes
Lead sponsor: Chinese Association of Geriatric Research
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 1724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of newly diagnosed diabetes
timeFrame: The primary outcome will be evaluated when the last subject completes 2 years' intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Chinese Association of Geriatric Research
name: Guangwei Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.