Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to investigate and evaluate the effects of different interventions (1. exenatide, 2. insulin, 3. thiazolidinedione) on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Detailed Description

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One of the fundamental defects in type 2 diabetes mellitus is declining β-cell function. Exenatide targets multiple metabolic disturbances in type 2 diabetes and exerts direct effects on β-cell, which indicates that it may not only contribute to the glucose control but also delay disease progression. There are trials demonstrated efficacy, safety and tolerability of exenatide. However, no study has compared the effects of exenatide with other hypoglycemic therapies with β cell protective function in newly diagnosed and drug-naïve type 2 diabetic patients. This current study is thus designed to evaluate the effects of exenatide, insulin and pioglitazone on glycemic control and β-cell function in newly diagnosed drug-naïve type 2 diabetic patients.

Conditions

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Diabetes Mellitus, Type 2 Newly Diagnosed

Keywords

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diabetes mellitus, type 2 newly diagnosed exenatide premixed insulin analog thiazolidinedione β-cell function glycemic control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exenatide

Group Type ACTIVE_COMPARATOR

exenatide injection

Intervention Type DRUG

Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.

Premixed insulin analog

Group Type ACTIVE_COMPARATOR

Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R

Intervention Type DRUG

Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.

pioglitazone

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.

Interventions

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exenatide injection

Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.

Intervention Type DRUG

Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R

Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.

Intervention Type DRUG

Pioglitazone

Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.

Intervention Type DRUG

Other Intervention Names

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Byetta®(Eli Lilly and Company) Humalog Mix 25®（Eli Lilly and Company)

Eligibility Criteria

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Inclusion Criteria

* newly-diagnosed type 2 diabetic patients, drug naïve
* age 30\~70 years
* HbA1c 7.0\~10.0%
* 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

Exclusion Criteria

* acute or severe chronic diabetic complications
* congestive heart failure (NYHA grade Ⅲ\~Ⅳ)
* severe gastrointestinal disease
* severe osteoporosis or history of pathological fracture,or use of bisphosphonates preparation
* 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
* serum triglyceride ≥ 5.0 mmol/L
* pregnancy

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jianping Weng

professor, vice president, the third affiliated hospital of Sun Yat-sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianping Weng, Doctor

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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