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Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients

NCT01776788 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2015-03-10

No results posted yet for this study

Summary

The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

insulin lispro injection, exenatide injection

First, Patients in the exenatide group will receive short-term continuous subcutaneous insulin (CSII)therapy. The doses will be titrated every day in order to attain the glycaemic goal which is defined as a fasting capillary blood glucose of less than 6.1 mmol/L and capillary blood glucose at 2 h after each of three meals of less than 8.0 mmol/L. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then, patients will Sequential be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 8 weeks. After interventions will be stopped, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly

DRUG

insulin lispro injection

Patients in the control group will receive insulin with an insulin pump. The doses will be titrated every day in order to attain the glycaemic goal. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then interventions will be stop, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Xue-jun Li, MD,PhD · The First Affiliated Hospital of Xiamen University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01776788 on ClinicalTrials.gov