Back to resultsEfficacy of Metformin in Preventing Diabetes in China (ChinaDPP)
Primary Purpose
PreDiabetes
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
metformin
Standard lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes
Eligibility Criteria
Main Inclusion Criteria:
- 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.
Main exclusion Criteria:
- 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.
- Uncontrolled thyroid diseases.
- Women who are pregnant or breastfeeding .
- Participation in another clinical trial within the past 30 days .
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Sites / Locations
- The Second Hospital of Hebei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
metformin plus standard lifestyle intervention
Standard lifestyle intervention
Arm Description
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.
Standard lifestyle advice will be united for all subjects by providing special booklet.
Outcomes
Primary Outcome Measures
Rate of newly diagnosed diabetes
Secondary Outcome Measures
Full Information
NCT ID
NCT03441750
First Posted
February 15, 2018
Last Updated
November 12, 2021
Sponsor
Chinese Association of Geriatric Research
1. Study Identification
Unique Protocol Identification Number
NCT03441750
Brief Title
Efficacy of Metformin in Preventing Diabetes in China
Acronym
ChinaDPP
Official Title
A Multicentre, Open-labelled, Randomized, Controlled Study to Evaluate the Efficacy of Metformin in Preventing Diabetes in China.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Association of Geriatric Research
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1724 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin plus standard lifestyle intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard lifestyle intervention
Arm Type
Other
Arm Description
Standard lifestyle advice will be united for all subjects by providing special booklet.
Intervention Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Glucophage immediate release formulation
Intervention Description
Metformin tablets will be administrated in the experimental arm.
Intervention Type
Other
Intervention Name(s)
Standard lifestyle intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of newly diagnosed diabetes
Time Frame
The primary outcome will be evaluated when the last subject completes 2 years' intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
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.
Main exclusion Criteria:
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.
Uncontrolled thyroid diseases.
Women who are pregnant or breastfeeding .
Participation in another clinical trial within the past 30 days .
Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangwei Li, M.D., Ph.D.
Organizational Affiliation
Chinese Association of Geriatric Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31512365
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.
Results Reference
derived
Learn more about this trial
Efficacy of Metformin in Preventing Diabetes in China
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