Type2 Diabetes
Conditions
Keywords
type 2 diabetes, remission, short-term intensive insulin therapy
Brief summary
To evaluate the long-term remission rate of short-term intensive insulin (STII) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.
Interventions
DRUGNovolin 30R;Pioglitazone;Metformin
* Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued; * Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin; * Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone.
Sponsors
Qianfoshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed, insulin-naive type 2 diabetes outpatients * Diabetes duration less than 1 year
Exclusion criteria
* Various acute complications * Hepatic transaminase \>2.5x normal reference value (glutamic-pyruvic transminase\>100U/L, glutamic-oxalacetic transaminase \> 100U/L) * Abnormal renal functions (serum cretinine\>the normal reference value) * Cardiac insufficiency (America NYHA caediac function \>3) * Type 1 diabetes mellitus * Ongoing hormone therapy * Women in gestation and lactation * Patients with other endocrine disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prolonged-remission rate | 5 years | hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration. |
| partial-remission rate | 5 years | hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years. |
Countries
China
Outcome results
None listed