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Metformin single drug control is not good in patients with type 2 diabetes mellitus The effect of ting on intestinal flora and bile acid metabolism

Evaluation of the efficacy of single dose or combination of sitagliptin in patients with type 2 diabetes mellitus under the control of metformin

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031128
Enrollment
Unknown
Registered
2020-03-22
Start date
2020-03-10
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

Group 2:metformin 2000mg/d
Group 1:Sitagliptin 100mg/d

Sponsors

the First Affiliated Hospital Division of Life Sciences and Medicine University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. T2D was diagnosed; 2. Aged 18 to 75 years old; 3. at least 10 weeks of stable metformin (1500mg / day) monotherapy was received before screening; 4. poor blood glucose control (HbA1c 7% to 10%); 5. Willing to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with endocrine and metabolic diseases affecting energy metabolism; 2. participate in weight loss programs, including drugs and surgery (within 12 months), or weight loss of more than 5% in the last three months; 3. surgery or planned surgery within 4 weeks; receive or need corticosteroid treatment or repeated treatment for more than 2 weeks; 4. serious digestive system diseases or digestive dysfunction; 5. serious liver diseases, such as cirrhosis (light to Moderate fatty liver can be selected); 6. obvious abnormality of liver and kidney function: serum creatinine level is more than 1.5 times of the upper limit value, or EGFR is less than 45ml / min / 1.73m2 calculated according to MDRD; 7. serum ALT and / or AST is more than 3 times of the upper limit value, or there are other obvious abnormal indexes; 8. accompanied with organ and system diseases, coronary heart disease, heart failure and related diseases; 9. mental disease; malignant tumor; participating in other intervention tests; 10. pregnant and lactating women; 11. using recreational or contraband drugs, or having a recent history of drug or alcohol abuse; 12. history of drug intolerance or allergy or contraindications; 13. history of medullary thyroid cancer.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Countries

China

Contacts

Public ContactZheng Xueying

the First Affiliated Hospital Division of Life Sciences and Medicine University of Science and Technology of China

lisazhengxy@163.com+86 0551-62284208

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026