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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
Ministry of Health, China
Information provided by (Responsible Party):
Jianping Weng, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01147627
First received: June 18, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Newly Diagnosed
Drug: exenatide injection
Drug: Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R
Drug: Pioglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients Achieving HbA1c <7% and ≤ 6.5% and Effect of Different Interventions on Fasting and Postprandial Plasma Glucose Concentration, Blood Pressure, Lipid Profiles [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • β-cell Function (Acute Insulin Response During IVGTT; HOMA-B, Disposition Index and Proinsulin/Insulin Ratio) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability in Different Groups [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 416
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exenatide Drug: 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.
Other Name: Byetta®(Eli Lilly and Company)
Active Comparator: Premixed insulin analog 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.
Other Name: Humalog Mix 25®(Eli Lilly and Company)
Active Comparator: pioglitazone 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147627

  Show 25 Study Locations
Sponsors and Collaborators
Sun Yat-sen University
Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
Ministry of Health, China
Investigators
Study Director: Jianping Weng, Doctor Third Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Jianping Weng, professor, vice president, the third affiliated hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01147627     History of Changes
Other Study ID Numbers: IIT-201007-WJP
Study First Received: June 18, 2010
Results First Received: June 6, 2013
Last Updated: June 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
diabetes mellitus, type 2
newly diagnosed
exenatide
premixed insulin analog
thiazolidinedione
β-cell function
glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Pioglitazone
Exenatide
2,4-thiazolidinedione
Insulin
Insulin Lispro
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014