The Effects of Short-Term Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

Status

Status unknown

Phase

Phase 4

Enrollment

160 participants (estimated)

Sponsor

Taipei Veterans General Hospital, Taiwan · Other gov

Design

Randomized · Open label (no masking)

Countries

1 country

Taiwan

Start

Nov 2010

Primary completion

Dec 2014 (estimated)

Completion

Dec 2015 (estimated)

First posted

5 Jan 2011 (estimated)

Last update posted

27 Jun 2013 (estimated)

Conditions

Type 2 Diabetes

Whether GLP-1 and GLP-1 receptor agonists will produce a sustained improvement in beta-cell function following short-term therapy is currently not known. This randomized, controlled trial is carried to assess the efficacy of short-term insulin therapy (NPH injection twice daily) compared with GLP-1 analogue (Exenatide injection twice daily) on glycemic control, remission rate, ß-cell function, and long-term glycemic control in newly diagnosed type 2 diabetic patients with moderate hyperglycemia.

• Experimental

  Exenatide

  In the exenatide therapy group, subjects will be instructed in the techniques for injection and be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 12 weeks. They also visit every 2 weeks in the first 2 visits and then every month until 4 months. If FPG still greater than 200 mg/dL after 4 weeks of exenatide treatment, they will use insulin for rescue therapy and will be withdrawn from this study.

• Active comparator

  Humulin-N

  In the insulin therapy group (Humulin-N), subjects will be instructed in the techniques for insulin injection and home capillary glucose monitoring. The insulin dose will be initiated with 0.25 unit/Kg per day, and the two thirds of daily dose will be administrated before breakfast and the other will be administrated at bedtime. Insulin doses will be titrated every 3 days to achieve target fasting blood glucose values between 70 and 130 mg/dl.

1. the time of glycemic remission and remission rate

   Time frame · at one year

   Registry description

   The primary outcomes are the time of glycemic remission and remission rate at one year after short-term therapy.

2. The time of monotherapy failure and monotherapy failure rate

   Time frame · 5 years

   Registry description

   The primary outcomes at 5 years are long-term glycemic control. After 5 months of intensive therapy, these patients were off medication and follow up in our clinics. When diabetes relapsed, they will be treated with metformin monotherapy. The monotherapy failure is defined as A1C \>7.0% with metformin 1500 mg per day.