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

Type2 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030300
• Other study ID #: qfsnfm-005
• Status: Completed
• Phase: Phase 4
• First received: January 2, 2017
• Last updated: January 24, 2017
• Start date: January 2008
• Est. completion date: February 2015

Study information

• Verified date: January 2017
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
China	Qianfoshan Hospital	Jinan	Shandong
China	Qilu Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolonged-remission rate	hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.	5 years
Primary	partial-remission rate	hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of more than 3 months' duration, and less than 5 years.	5 years