NCT01147627

Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Detailed description

One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Conditions

• Diabetes Mellitus, Type 2
• Newly Diagnosed

Interventions

Type	Name	Description
DRUG	exenatide injection	Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.
DRUG	Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R	Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.
DRUG	Pioglitazone	Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-12-01
• First posted: 2010-06-22
• Last updated: 2013-08-21
• Results posted: 2013-08-21

Locations

25 sites across 1 country: China