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

NCT01270191 | Unknown Phase 4

• 1 other identifier: VGHIRB 201010013MB
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Exenatide, Beta-Cell Function, Glycemic Control; in Newly Diagnosed Type 2 Diabetic Patients

Outcome Measures

Primary Outcomes (2)

• the time of glycemic remission and remission rate

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

  at one year

• The time of monotherapy failure and monotherapy failure rate

  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.

  5 years

Secondary Outcomes (3)

• Beta-cell function and insulin sensitivity calculated from OGTT.

  at 6 months

• Comparison of A1C change, the proportion of subjects who reached the treatment target

  6-12 months

• Comparison of A1C change, the proportion of subjects who reached the treatment target

  5 years

Study Arms (2)

Exenatide

EXPERIMENTAL

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still greater than 200 mg/dL after 4 weeks of exenatide treatment, they will use insulin for rescue therapy and will be withdrawn from this study.

Drug: Exenatide

Humulin-N

ACTIVE COMPARATOR

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.

Drug: Humulin-N

Interventions

Exenatide DRUG

They will 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.

Also known as: Byetta

Exenatide

Humulin-N DRUG

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.

Also known as: NPH insulin

Humulin-N

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.
• Age between 30 and 70 years old.
• HbA1C between 7 and 9% in OPD patients
• If HbA1c \>9.0% of blood glucose \>300 mg/dL, intensive insulin therapy for 10-14 days

You may not qualify if:

• Previous treated with anti-diabetic medication
• Pregnant or lactation women.
• Impaired liver function (ALT \> 100 U/L)
• Impaired renal function (Serum creatinine \>2.0 mg/dL)
• Recently suffered from MI or CVA.
• Patients are acute intercurrent illness.
• hour C-peptide level \< 2.0 ng/mL.
• History of severe hypersensitivity to any product components.
• History or high risk of acute pancreatitis.
• Now use warfarin.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide; Insulin, Isophane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Harn-Shen Chen, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Veterans General Hospital

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 5, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

TW (1)