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
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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COMPLETED
PHASE4
170 participants
INTERVENTIONAL
2008-01-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
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).
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diabetes duration less than 1 year
Exclusion Criteria
* 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
18 Years
78 Years
ALL
No
Sponsors
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Qianfoshan Hospital
OTHER
Responsible Party
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Lin Liao
chief of endocrinology department at Qianfoshan Hospital
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
Qianfoshan Hospital
Jinan, Shandong, China
Qilu Hospital
Jinan, Shandong, China
Countries
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Other Identifiers
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qfsnfm-005
Identifier Type: -
Identifier Source: org_study_id
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