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

NCT ID: NCT03030300

Last Updated: 2017-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Novolin 30R;Pioglitazone;Metformin

Intervention Type DRUG

* 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lin Liao

chief of endocrinology department at Qianfoshan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Liao, MD

Role: STUDY_CHAIR

Qianfoshan Hospital

Locations

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Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Qianfoshan Hospital

Jinan, Shandong, China

Site Status

Qilu Hospital

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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qfsnfm-005

Identifier Type: -

Identifier Source: org_study_id

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