AzTrials
AzTrials

PreDiabetesPhase 4ChinaDPPNCT03441750

Efficacy of Metformin in Preventing Diabetes in China

A Phase 4 study testing metformin and Standard lifestyle intervention in people with PreDiabetes, run by Chinese Association of Geriatric Research at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PreDiabetes
What is being tested?
metformin and Standard lifestyle intervention
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,724 participants
Where
1 siteChina
Study dates
25 Apr 2017to 30 Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
PreDiabetes
Being tested
metformin, Standard lifestyle intervention
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metforminDrug

    Also called Glucophage immediate release formulation

    Metformin tablets will be administrated in the experimental arm.

  • Standard lifestyle interventionOther

    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.
Study groups in NCT03441750
Study groupRoleWhat they receive
metformin plus standard lifestyle interventionExperimentalMetformin 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.
Receives: Drug: metformin
Standard lifestyle interventionOtherStandard lifestyle advice will be united for all subjects by providing special booklet.
Receives: Other: Standard lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of newly diagnosed diabetes

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start25 Apr 2017
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,724 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03441750
Sponsor's protocol ID
ChineseAGR
Acronym
ChinaDPP
Status last verified
Nov 2021
First submitted
15 Feb 2018
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37414069

  • 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.

    PubMed 31512365

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metformin and Standard lifestyle intervention in people with PreDiabetes, run by Chinese Association of Geriatric Research at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of newly diagnosed diabetes (time frame: The primary outcome will be evaluated when the last subject completes 2 years' intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03441750, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in