NCT01276912

Study TO Prevent Diabetes With Short-term Insulin Glargine Only

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,420 (estimated)
• Sponsor: Beijing Tongren Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DRUG	Insulin glargine	Insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling.
BEHAVIORAL	Lifestyle counseling	To give lifestyle guidance, specifically including low fat, low saturated fatty acids, rich in dietary fiber, salt restriction, limit alcohol diet plan to reduce the 5% to 10% of body weight, and to ensure a regular moderate physical activity at least 150 minutes per week.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2011-01-14
• Last updated: 2011-01-14

Locations

1 site across 1 country: China