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Optimized threapy for obeses individuals with type 2 diabetes

The study about change high-dose insulin to non-insulin therapy in obese individuals with type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003499
Enrollment
Unknown
Registered
2013-07-28
Start date
2013-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Type 2 diabetes

Interventions

Insulin group:Continue to use insulin and ajust the dose of insulin
Non-insulin group:Stop insulin therapy and change to other non-insulin therapy

Sponsors

The Second Affliated Hospital to Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female 18 -75 years of age; 2. Type 2 diabetes mellitus (diagnosed clinically) for >=3 years; 3. Current treatment: Insulin or insulin analogue dose >=40IU/day, and in any combination with less than two types oral hypoglycemic drugs, their dose are less than half of maximum dosage (metformin=25.0 kg/m2; 5. HbA1c 7.0-10.0%; 6. Serum C peptide>=1.5ug/L.

Exclusion criteria

Exclusion criteria: 1. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods; 2. Cardiovascular disease, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)26 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; 3. Patients with serious gastrointestinal disease, for example: Peptic Ulcer, chronic diarrhea, pancreatitis; 4. Other endocrine disease, such as hyperthyroid disease, hypercortisolism; 5. Type 1 diabetes; 6. Proliferative retinopathy or maculopathy; 7. Impaired liver function, defined as ALAT or ASAT >=2.5 times upper limit of normal; 8. Impaired renal function defined as serum-creatinine >=125umol/L (>=1.4 mg/dL) for males and >=110umol/L (>=1.3 mg/dL) for females; 9. White blood cell < 3.5×10^9/Lblood platelet < 60×10^9/L, hemoglobin male <110g/L; female <100g/L; 10. Uncontrolled treated/untreated severe hypertension (systolic blood pressure 180 millimetre(mm) mercury (Hg) and/or diastolic blood pressure 100 mmHg); 11. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors 12. Accepted the GLP-1 analogue or DDP4 inhibitor therapy; 13. Cancer and medical history of cancer; 14. Alcoholics or drug addict; 15. Suffer surgery or other stress; 16. Be allergic or with serious adverse Reaction to any of oral anti diabetic drugs; 17. Use of herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
Insulin;C peptide;FBG;PBG;

Countries

China

Contacts

Public ContactDongfang Liu
ldf023023@aliyun.com+86 18623407751

Outcome results

None listed

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