Trial | NCT03030300  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    170
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.
Study Started
Jan 31
2008
Primary Completion
Feb 28
2015
Study Completion
Feb 28
2015
Last Update
Jan 25
2017
Estimate

Drug Novolin 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.

Novolin 30R;Pioglitazone;Metformin Experimental

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

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
No Results Posted