Skip to content

Study of efficacy and safety of higher starting dose of insulin glargine in overweight and obese newly-diagnosed hospitalized patients with type 2 diabetes

Study of efficacy and safety of higher starting dose of insulin glargine in overweight and obese newly-diagnosed hospitalized patients with type 2 diabetes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17011018
Enrollment
Unknown
Registered
2017-03-30
Start date
2017-05-30
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

diabetes mellitus

Interventions

one:higher starting dose of insulin glargine (0.4U/kg)
two:standard starting dose of insulin glargine (0.2U/kg)

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Type 2 diabetes patients with diabetes diagnosis less than 1 year (WHO 1999 T2DM diagnose criteria); 3. Do not use any hypoglycemic drugs, or used metformin, the sulfonylureas medications or acarbose treatment less than 1 year; 4. HbA1c=8.0%; 5. FPG=10mmol/L; 6. BMI=24kg/m2.

Exclusion criteria

Exclusion criteria: 1. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake); 2. Impaired renal function defined as, but not limited to, serum creatinine levels =1.5 mg/dL (132 umol/L) for males and =1.4 mg/dL (123umol/L) for females or presence of macroproteinuria (>2 g/day); 3. Active liver disease (ALT greater than two times the upper limit of the reference range, as defined by the local laboratory); 4. Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma); 5. History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months; 6. History of congestive heart failure; 7. Acute infections which may affect blood glucose control within 4 weeks prior to study entry; 8. Chronic oral or parenteral corticosteroid treatment (>7 consecutive days of treatment) within 8 weeks prior to study entry. Treatment with growth hormone or similar drugs those have an obvious impact on blood glucose value; 9. Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method); 10. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikely completing the study.

Design outcomes

Primary

MeasureTime frame
fasting glucose success rate;hypoglycemia;

Secondary

MeasureTime frame
1,5-Anhydroglucitol;Glycated hemoglobin A1c;total dose of insulin;patients of stop using insulin in the follow-up;

Countries

China

Contacts

Public ContactLI HAIYAN

Shenzhen Second People's Hospital

haiyanli78@163.com+86 13316880870

Outcome results

None listed

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