Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates
      over time in people with type 2 diabetes mellitus, irrespective of lifestyle and existing
      pharmacological interventions. The progressive nature of type 2 diabetes is one of the major
      challenges in the treatment of affected patients, and agents that could alter the natural
      history of this condition would add greatly to current treatment approaches. Short-term
      intensive insulin therapy of newly diagnosed type 2 diabetes will improve beta-cell function
      and usually leading to a temporary remission time. The effect of GLP-1 receptor agonists on
      beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of
      insulin biosynthesis. It is stimulating beta-cell proliferation, induction of islet
      neogenesis, and inhibition of ß-cell apoptosis. Exenatide is synthetic exendin-4, GLP-1
      receptor agonist. Exenatide exerts direct effects on β-cell, which indicates that may
      contribute to delay disease progression. However, no study has evaluated effect of short-term
      intensive insulin sequential exenatide therapy model on β-cell function and glycemic
      remission rate in newly diagnosed type 2 diabetic patients. This current study is thus
      designed to evaluate effect of short-term intensive insulin sequential exenatide therapy
      model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed
      type 2 diabetic patients.
    

Intervention name(s): insulin lispro injection, exenatide injection; insulin lispro injection
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment