A Phase 2 interventional study of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Diabetes Mellitus, Type 2, sponsored by Beijing Supreme Life Pharmaceutical Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Beijing Supreme Life Pharmaceutical Technology Co., Ltd. · Phase 2, Interventional, and Treatment
This trial tests whether Fuling Yunhua Granules and Dihuang Baoyuan Granules, given in sequence with or without continued metformin, lower blood sugar in adults with type 2 diabetes already taking metformin. It will also assess their safety.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. About 150 participants aged 18-70 will be randomly assigned to one of six groups: sequential low-dose study drug plus metformin, sequential high-dose study drug plus metformin, sequential low-dose study drug plus matched metformin placebo, sequential high-dose study drug plus matched metformin placebo, low-dose matched placebo plus metformin, or high-dose matched placebo plus metformin. Neither participants nor researchers will know who gets which treatment.
The trial includes a 4-week run-in period on stable metformin, 24 weeks of daily treatment, and a 12-week follow-up after stopping the study medicines. Participants whose blood sugar stays healthy may continue follow-up for up to 52 weeks after stopping the study medicines.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Beijing Supreme Life Pharmaceutical Technology Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any laboratory test meets any of the following criteria at screening:
(ALT) or aspartate aminotransferase (AST) > (ULN) ×2.5, or total (TBIL) > ULN ×1.5; Estimated (eGFR) \<60 mL/min/1.73 m2 calculated using the CKD-EPI formula; Fasting triglycerides (TG) >5.7 mmol/L; Fasting C-peptide \<0.8 ng/mL (or 0.26 nmol/L); \<100 g/L;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks, in combination with stable-dose metformin: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag orally twice daily before breakfast and dinner.
Drug: Fuling Yunhua Granules · Drug: Dihuang Baoyuan Granules · Drug: Metformin
Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks, in combination with stable-dose metformin: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag orally three times daily before breakfast, lunch and dinner.
Drug: Fuling Yunhua Granules · Drug: Dihuang Baoyuan Granules · Drug: Metformin
Description Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks, in combination with matched metformin placebo: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag orally twice daily before breakfast and dinner.
Drug: Fuling Yunhua Granules · Drug: Dihuang Baoyuan Granules · Drug: Metformin Matched Placebo
Dihuang Baoyuan Granules and Fuling Yunhua Granules alternately every 4 weeks for 24 weeks, in combination with matched metformin placebo: Dihuang Baoyuan Granules in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua Granules in weeks 5-8, 13-16 and 21-24. One bag orally three times daily before breakfast, lunch and dinner.
Drug: Fuling Yunhua Granules · Drug: Dihuang Baoyuan Granules · Drug: Metformin Matched Placebo
Matched placebos for Dihuang Baoyuan Granules and Fuling Yunhua Granules in the same alternating 4-week sequence, in combination with stable-dose metformin: Dihuang Baoyuan matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua matched placebo in weeks 5-8, 13-16 and 21-24. One bag orally twice daily before breakfast and dinner, for 24 weeks.
Drug: Fuling Yunhua Granules Matched Placebo · Drug: Dihuang Baoyuan Granules Matched Placebo · Drug: Metformin
Matched placebos for Dihuang Baoyuan Granules and Fuling Yunhua Granules in the same alternating 4-week sequence, in combination with stable-dose metformin: Dihuang Baoyuan matched placebo in weeks 1-4, 9-12 and 17-20, and Fuling Yunhua matched placebo in weeks 5-8, 13-16 and 21-24. One bag orally three times daily before breakfast, lunch and dinner, for 24 weeks.
Drug: Fuling Yunhua Granules Matched Placebo · Drug: Dihuang Baoyuan Granules Matched Placebo · Drug: Metformin
Traditional Chinese herbal medicine granules, 12 g per bag, taken orally before meals.
Traditional Chinese herbal medicine granules, 18 g per bag, taken orally before meals.
Matched placebo for Fuling Yunhua Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 12 g per bag, taken orally before meals.
Matched placebo for Dihuang Baoyuan Granules; identical in appearance (shape, color and packaging), odor and taste, but containing no active herbal components. Granules, 18 g per bag, taken orally before meals.
Oral biguanide antihyperglycemic agent, 0.5 g per tablet, taken orally as stable background therapy throughout the study.
Matched placebo for metformin; identical in appearance (shape, color and packaging) to metformin tablets, but containing no active pharmaceutical ingredients. Tablets, 0.5 g per tablet, taken orally.
Change from Baseline in Glycated Hemoglobin (HbA1c) at Week 24
Time frame: Baseline and Week 24
Proportion of Participants Achieving Clinical Glycemic Target at 12 Weeks After Discontinuation of Study Drug (Clinical achievement defined as HbA1c <6.5% under continued background therapy with or without metformin)
Time frame: 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Glycated Hemoglobin (HbA1c) at Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, and 12 Weeks After Discontinuation of Study Drug
Proportion of Participants With HbA1c <6.5% at Weeks 8, 12, 16, and 24
Time frame: Weeks 8, 12, 16, and 24
Proportion of Participants With HbA1c <7.0% at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in 2-Hour Postprandial Glucose (PPG) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Continuous Glucose Monitoring (CGM) Time in Range (TIR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Below Range (TBR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Continuous Glucose Monitoring (CGM) Time Above Range (TAR) at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Insulin Sensitivity (HOMA-IS) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Beta-Cell Function (HOMA-β) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in C-Peptide Index (CPI) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Lipid Profile (Total Cholesterol [TC], LDL-C, HDL-C, Triglycerides [TG]) at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Systolic and Diastolic Blood Pressure at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Serum Uric Acid at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Fasting Body Weight at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Waist Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Hip Circumference at Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Baseline and Weeks 4, 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Traditional Chinese Medicine Syndrome Score at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
The Traditional Chinese Medicine Syndrome Scale for Type 2 Diabetes Mellitus. The total score ranges from 0 to 33 or 0 to 36, depending on the TCM syndrome pattern. Higher scores indicate more severe symptoms (worse outcome).
Time frame: Baseline and Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Proportion of Participants by Traditional Chinese Medicine Efficacy (Cured, Markedly Effective, Effective, Ineffective) at Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Time frame: Weeks 8, 12, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
The Pittsburgh Sleep Quality Index. Total score ranges from 0 to 21. Higher scores indicate worse sleep quality.
Time frame: Baseline and Weeks 8, 16, 24, and 12 Weeks After Discontinuation of Study Drug
Change from Baseline in Telomere Length at Week 24
Time frame: Baseline and Week 24
Change from Baseline in Mitochondrial DNA Copy Number at Week 24
Time frame: Baseline and Week 24
Proportion of Participants Achieving Glycemic Target at 24, 36, and 52 Weeks After Discontinuation of Study Drug
Time frame: 24, 36, and 52 Weeks After Discontinuation of Study Drug
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Beijing Supreme Life Pharmaceutical Technology Co., Ltd.