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

Phase 4

Completed

• Conditions: Type2 Diabetes
• Interventions: Drug: Novolin 30R;Pioglitazone;Metformin

• Registration Number: NCT03030300
• Lead Sponsor: Qianfoshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novolin 30R;Pioglitazone;Metformin	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).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Qilu Hospital; 🇨🇳 Jinan, Shandong, China

Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China