Type 2 DiabetesMDEITMNCT07778719
Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD
A study testing Metformin + Dapagliflozin and Metformin in people with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The 95th Hospital of Putian，Putian, Fujian, China at 1 site in China.
Trial summary
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes, Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Metformin + Dapagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 11 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Males aged 30-60 years;
- Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;
- Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks;
- Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB/m detected, with the presence of at least one cardiometabolic risk factor;
- No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;
- Willing to participate voluntarily and sign the informed consent form.
Who cannot join
- Type 1 diabetes mellitus or other specific types of diabetes;
- Weekly alcohol intake exceeding 210g for males;
- Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);
- Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;
- Previous or current use of GH preparations or IGF-1 preparations;
- Baseline estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m²;
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- Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);
- Active malignant tumors;
- Allergy to dapagliflozin or similar drugs;
- Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;
- Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Ethics Committee of Putian 95 Hospital
Putian, Fujian, 351100
Xuebai Chen, 18760590880, Chenxuebai@126.com
123357213@qq.com
About this study
Official title: Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.
Read the detailed description
Screening \& Enrollment (-1 to 0 week): Male T2DM patients on stable metformin (≥1500 mg/d) for ≥8 weeks are screened. CAP measurement via FibroScan® confirms MASLD (≥248 dB/m). Eligible patients provide written informed consent.
Baseline \& Randomization (Day 0): Comprehensive assessments include demographics, physical exam, laboratory tests (FPG, HbA1c, insulin, HOMA-IR, liver/renal function, lipids, hsCRP), serum IGF-1/IGFBP3, and FibroScan® (CAP/LSM). Patients are then randomized 1:1 to control (metformin alone) or experimental (metformin + dapagliflozin 10 mg/d) groups.
Follow-up (Weeks 4 and 12): At Week 4, patients undergo physical exam, FPG, HbA1c, liver/renal function tests, adverse event recording, and adherence assessment. At Week 12, all baseline assessments are repeated, including IGF-1/IGFBP3 and FibroScan®, to evaluate changes from baseline.
Data Analysis (Weeks 13-24): Data are double-entered, cleaned, and locked. Primary analysis compares ΔIGF-1 between groups using t-test/Mann-Whitney U test with ANCOVA adjustment. Secondary endpoints, correlations, and subgroup analyses are performed. All tests are two-sided with significance at P < 0.05 using SPSS or R software.
- Being tested
- Metformin + Dapagliflozin, Metformin
- Keywords
- Dapagliflozin, Metformin, Serum IGF-1, Type 2 Diabetes Mellitus, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin + DapagliflozinDrug
Maintain the stable pre-enrollment dose of metformin (≥1500 mg/day or maximum tolerated dose) plus dapagliflozin 10 mg/day orally, administered once daily before breakfast, for 3 consecutive months.
Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required.
Patients should be instructed to maintain stable dietary and exercise habits throughout the study.
MetforminDrug
Maintain the stable pre-enrollment dose of metformin monotherapy (≥1500 mg/day or maximum tolerated dose) for 3 consecutive months.
Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required.
Patients should be instructed to maintain stable dietary and exercise habits throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Metformin groups | Active comparator | Continue monotherapy with metformin (maintain the original dose). Receives: Drug: Metformin |
| Metformin+ Dapagliflozin group | Experimental | Metformin (maintain the original dose) + Dapagliflozin 10 mg/day Receives: Drug: Metformin + Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔIGF-1
The difference in the change value of serum IGF-1 levels (ΔIGF-1) from baseline to 3 months between the two groups.
Measured: 12 weeks
Changes in non-invasive indicators of liver fibrosis
Differences in the change values of the FIB-4 index from baseline to 3 months between the two groups
Measured: 12 weeks
Secondary outcomes (8)
Changes in liver fat content
Differences in the change value of CAP (ΔCAP) from baseline to 3 months between the two groups
Measured: 12 weeks
Changes in non-invasive indicators of liver fibrosis
Differences in the change values of LSM from baseline to 3 months between the two groups
Measured: 12 weeks
ΔIGF-1/IGFBP3 molar ratio
Differences in changes in the IGF-1/IGFBP3 molar ratio between the two groups
Measured: 12 weeks
Changes in glucose metabolism indicators
Differences in HbA1c between the two groups
Measured: 12 weeks
ΔBMI
Differences in changes in BMI between the two groups
Measured: 12 weeks
Changes in liver function indicators
Differences in ALT, AST, and GGT between the two groups
Measured: 12 weeks
Changes in glucose metabolism indicators
Differences in fasting blood glucose between the two groups
Measured: 12 weeks
Changes in glucose metabolism indicators
Differences in HOMA-IR between the two groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The 95th Hospital of Putian，Putian, Fujian, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rongfeng Zhu, Study chair, The 95th Hospital of Putian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778719
- Sponsor's protocol ID
- 2026JW001-20
- Acronym
- MDEITM
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research containing personal information cannot be disclosed without the consent
Publications
Srimanus K, Damrongmanee A, Ukarapol N, Chattipakorn N, Chattipakorn SC. Unveiling the link between insulin-like growth factor 1 (IGF-1) and fatty liver progression: From bench to bedside. Biochim Biophys Acta Mol Basis Dis. 2026 Jun;1872(5):168218. doi: 10.1016/j.bbadis.2026.168218. Epub 2026 Mar 6.
PubMed 41796683Ma IL, Stanley TL. Growth hormone and nonalcoholic fatty liver disease. Immunometabolism (Cobham). 2023 Jul 27;5(3):e00030. doi: 10.1097/IN9.0000000000000030. eCollection 2023 Jul.
PubMed 37520312Kineman RD, Del Rio-Moreno M, Waxman DJ. Liver-specific actions of GH and IGF1 that protect against MASLD. Nat Rev Endocrinol. 2025 Feb;21(2):105-117. doi: 10.1038/s41574-024-01037-0. Epub 2024 Sep 25.
PubMed 39322791Dichtel LE, Cordoba-Chacon J, Kineman RD. Growth Hormone and Insulin-Like Growth Factor 1 Regulation of Nonalcoholic Fatty Liver Disease. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1812-1824. doi: 10.1210/clinem/dgac088.
PubMed 35172328
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT07778719
- Acronym / sponsor ID
- MDEITM / 2026JW001-20
- Keywords
- Dapagliflozin, Metformin, Serum IGF-1, Type 2 Diabetes Mellitus, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The 95th Hospital of Putian，Putian, Fujian, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB/m, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg/day for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.
Detailed description
Screening \& Enrollment (-1 to 0 week): Male T2DM patients on stable metformin (≥1500 mg/d) for ≥8 weeks are screened. CAP measurement via FibroScan® confirms MASLD (≥248 dB/m). Eligible patients provide written informed consent.
Baseline \& Randomization (Day 0): Comprehensive assessments include demographics, physical exam, laboratory tests (FPG, HbA1c, insulin, HOMA-IR, liver/renal function, lipids, hsCRP), serum IGF-1/IGFBP3, and FibroScan® (CAP/LSM). Patients are then randomized 1:1 to control (metformin alone) or experimental (metformin + dapagliflozin 10 mg/d) groups.
Follow-up (Weeks 4 and 12): At Week 4, patients undergo physical exam, FPG, HbA1c, liver/renal function tests, adverse event recording, and adherence assessment. At Week 12, all baseline assessments are repeated, including IGF-1/IGFBP3 and FibroScan®, to evaluate changes from baseline.
Data Analysis (Weeks 13-24): Data are double-entered, cleaned, and locked. Primary analysis compares ΔIGF-1 between groups using t-test/Mann-Whitney U test with ANCOVA adjustment. Secondary endpoints, correlations, and subgroup analyses are performed. All tests are two-sided with significance at P < 0.05 using SPSS or R software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin groups | Active comparator | Drug: MetforminContinue monotherapy with metformin (maintain the original dose). |
| Metformin+ Dapagliflozin group | Experimental | Drug: Metformin + DapagliflozinMetformin (maintain the original dose) + Dapagliflozin 10 mg/day |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males aged 30-60 years;
- Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;
- Having received a stable dose of metformin (≥1500 mg/day or the maximum tolerated dose) as monotherapy for at least 8 weeks;
- Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB/m detected, with the presence of at least one cardiometabolic risk factor;
- No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;
Key exclusion criteria (11 listed)
- Type 1 diabetes mellitus or other specific types of diabetes;
- Weekly alcohol intake exceeding 210g for males;
- Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);
- Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;
- Previous or current use of GH preparations or IGF-1 preparations;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin + DapagliflozinMaintain the stable pre-enrollment dose of metformin (≥1500 mg/day or maximum tolerated dose) plus dapagliflozin 10 mg/day orally, administered once daily before breakfast, for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study. | Drug | Metformin+ Dapagliflozin group |
| MetforminMaintain the stable pre-enrollment dose of metformin monotherapy (≥1500 mg/day or maximum tolerated dose) for 3 consecutive months. Other concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required. Patients should be instructed to maintain stable dietary and exercise habits throughout the study. | Drug | Metformin groups |
Primary outcome
ΔIGF-1
Time frame: 12 weeks
The difference in the change value of serum IGF-1 levels (ΔIGF-1) from baseline to 3 months between the two groups.
Changes in non-invasive indicators of liver fibrosis
Time frame: 12 weeks
Differences in the change values of the FIB-4 index from baseline to 3 months between the two groups
8 secondary outcomes
Changes in liver fat content
Time frame: 12 weeks
Changes in non-invasive indicators of liver fibrosis
Time frame: 12 weeks
ΔIGF-1/IGFBP3 molar ratio
Time frame: 12 weeks
Changes in glucose metabolism indicators
Time frame: 12 weeks
ΔBMI
Time frame: 12 weeks
Changes in liver function indicators
Time frame: 12 weeks
Changes in glucose metabolism indicators
Time frame: 12 weeks
Changes in glucose metabolism indicators
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 41796683Srimanus K, Damrongmanee A, Ukarapol N, Chattipakorn N, Chattipakorn SC. Unveiling the link between insulin-like growth factor 1 (IGF-1) and fatty liver progression: From bench to bedside. Biochim Biophys Acta Mol Basis Dis. 2026 Jun;1872(5):168218. doi: 10.1016/j.bbadis.2026.168218. Epub 2026 Mar 6.
- Background: PubMed 37520312Ma IL, Stanley TL. Growth hormone and nonalcoholic fatty liver disease. Immunometabolism (Cobham). 2023 Jul 27;5(3):e00030. doi: 10.1097/IN9.0000000000000030. eCollection 2023 Jul.
- Results publication: PubMed 39322791Kineman RD, Del Rio-Moreno M, Waxman DJ. Liver-specific actions of GH and IGF1 that protect against MASLD. Nat Rev Endocrinol. 2025 Feb;21(2):105-117. doi: 10.1038/s41574-024-01037-0. Epub 2024 Sep 25.
- Results publication: PubMed 35172328Dichtel LE, Cordoba-Chacon J, Kineman RD. Growth Hormone and Insulin-Like Growth Factor 1 Regulation of Nonalcoholic Fatty Liver Disease. J Clin Endocrinol Metab. 2022 Jun 16;107(7):1812-1824. doi: 10.1210/clinem/dgac088.
- Individual participant dataSharing planned: No. Research containing personal information cannot be disclosed without the consent
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rongfeng Zhu study chair
The 95th Hospital of Putian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin + Dapagliflozin and Metformin in people with Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease, run by The 95th Hospital of Putian，Putian, Fujian, China 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?
The sponsor lists 6 inclusion and 11 exclusion criteria. 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rongfeng Zhu, Dr (+8613706058931, 123357213@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ΔIGF-1 (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT07778719, which also lists 4 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 21 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.