A Multicenter, Randomized, Controlled Trial to Prevent Diabetes With Short-term Insulin Glargine Treatment or Lifestyle Intervention

Beijing Tongren Hospital1 site in 1 country2,420 target enrollmentJanuary 2011

Overview

Pre-diabetes is a significant risk factor for the development of type 2 diabetes, as well as macrovascular and microvascular complication.
Previous studies show that 50% or more loss in islet B-cell function even in Pre-diabetes phase. The early insulin therapy in pre-diabetes may be a strategy in preventing metabolic disorders and cardiovascular disease.
The objective of this study is to find if an initial insulin glargine intervention in pre-diabetes (IGT and /or IFG) could be a strategy in preventing type 2 Diabetes.
Pre-diabetes subjects will receive a insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal. Insulin glargine treatment will be maintained for three months thereafter to find if it can prevent diabetes.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

December 2013

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Beijing Tongren Hospital

•All participants are voluntary and write informed consent 2 weeks before enrollment.
•Fasting Blood Glucose between \>= 5.6mmol/L and \<7.0mmol/L, and HbA1c between \>= 5.7% and \<6.5%.
•Both male and female aged between \>= 25 and ≤ 65 years.
•Participants have the ability to use self-monitoring devices to measure their blood glucose level and practice self-insulin injection.
•Have the ability and willingness to complete the study logs and questionnaires.
•Pregnancy test of all child-bearing age women should be negative, and they agree to adopt contraceptive measures in the study process.

•With previous diagnosis of diabetes or application of hypoglycemic drugs.
•Preliminary screen for fasting plasma glucose lever ≥7.0mmol/L or \<5.6mmol/L.
•Preliminary screen for HbA1c result HbA1c\<5.7% or ≥ 6.5%.
•Receiving cancer treatment in the past 5 years.
•Preliminary diagnostic anti-HIV test result positive, with no serological testing.
•People with active tuberculosis.
•Persons hospitalized for heart disease and received the treatment measures (such as coronary artery bypass graft CABG, percutaneous transluminal coronary angioplasty PTCA), while not include diagnostic measures (such as percutaneous coronary angiography) in the past 6 months.
•Cardiac function evaluated by New York Heart Association criteria (NYHA) ≥ 3 cardiac function level
•Uncontrolled high blood pressure - systolic blood pressure \> 180mmHg or diastolic blood pressure \> 105mmHg after treatment.
•Stroke or transient ischemic attack episode in the past 6 months.