Study TO Prevent Diabetes With Short-term Insulin Glargine Only (STOP-GO)
|ClinicalTrials.gov Identifier: NCT01276912|
Recruitment Status : Unknown
Verified January 2011 by Beijing Tongren Hospital.
Recruitment status was: Recruiting
First Posted : January 14, 2011
Last Update Posted : January 14, 2011
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Pre-diabetes||Drug: Insulin glargine Behavioral: Lifestyle counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Controlled Trial to Prevent Diabetes With Short-term Insulin Glargine Treatment or Lifestyle Intervention|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
Drug: Insulin glargine
- HbA1c >= 6.5% [ Time Frame: Two years ]
- FPG >= 7.0 for two times in a month. [ Time Frame: Two years ]
- HbA1c >= 7.0% [ Time Frame: Two years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276912
|Contact: Jin-Kui Yang, M.D., Ph.D.||+firstname.lastname@example.org|
|Beijing Tongren Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Jin-Kui Yang, M.D., Ph.D. +86-10-58268445 email@example.com|