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

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.

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Key information

Conditions

Type2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Qianfoshan Hospital, Jinan, Shandong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novolin 30R;Pioglitazone;Metformin

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.

Primary outcomes

prolonged-remission rate

Time frame: 5 years

hyperglycemia below diagnostic thresholds for diabetes without active pharmacologic therapy or ongoing procedures of 5 years' duration.
partial-remission rate

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Jan 25, 2017
Registry last updated: Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed