Remission Rate of Newly Diagnosed Type 2 Diabetes Outpatients Treated With Short-term Intensive Insulin Therapy

Qianfoshan Hospital

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes

Treatments: Drug: Novolin 30R;Pioglitazone;Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03030300

qfsnfm-005

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

Novolin 30R;Pioglitazone;Metformin

Experimental group

Description:

Drugs: Insulin (Novolin 30R) monotherapy or combined with one or two oral drugs (metformin 0.5 mg tid and pioglitazone hydrochloride 15 mg qd).

Treatment:

Drug: Novolin 30R;Pioglitazone;Metformin