Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy
Overview
- Phase
- Phase 4
- Intervention
- Novolin 30R;Pioglitazone;Metformin
- Conditions
- Type2 Diabetes
- Sponsor
- Qianfoshan Hospital
- Enrollment
- 170
- Locations
- 3
- Primary Endpoint
- prolonged-remission rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Lin Liao
chief of endocrinology department at Qianfoshan Hospital
Qianfoshan Hospital
Eligibility Criteria
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
Arms & Interventions
Novolin 30R;Pioglitazone;Metformin
Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).
Intervention: Novolin 30R;Pioglitazone;Metformin
Outcomes
Primary Outcomes
prolonged-remission rate
Time Frame: 5 years
hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.
partial-remission rate
Time Frame: 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.