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

NCT01776788 | Completed Phase 4 DMC

• 1 other identifier: bmd-201207-xm
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the glycemic remission rate in different groups

  one year

Secondary Outcomes (2)

• the improvement of β-cell function in different groups.

  one year

• the time of glycemic remission in different groups

  one year

Study Arms (2)

insulin lispro injection, exenatide injection

EXPERIMENTAL

Drug: insulin lispro injection, exenatide injection

insulin lispro injection

ACTIVE COMPARATOR

Drug: insulin lispro injection

Interventions

insulin lispro injection, exenatide injection DRUG

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

insulin lispro injection, exenatide injection

insulin lispro injection DRUG

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.

insulin lispro injection

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly-diagnosed type 2 diabetic patients, drug naïve
• age 30\~70 years
• FPG 7.0\~16.7mmol/L
• BMI 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
• female patients of reproductive age should practice a reliable method of birth control throughout the study

You may not qualify if:

• acute or severe chronic diabetic complications
• Recently suffered from MI or CVA.
• severe gastrointestinal disease
• other severe intercurrent illness
• serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
• tested positive for glutamic acid decarboxylase antibody
• use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
• history of pancreatitis
• Pregnant or lactation women.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The first afilliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro; Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Xue-jun Li, MD,PhD

  The First Affiliated Hospital of Xiamen University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 28, 2013
• Study Start: August 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2013-01

Locations

CN (1)