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Effects of Different Early Intensive Therapies on Long-term β-cell Function

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01471808
First received: November 8, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: CSII
Drug: CSII, Metformin, Pioglitazone
Drug: CSII, Sitagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • the improvement of β-cell function after short intensive therapy in newly diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • the effects of different interventions on the remission rate in newly-diagnosed type 2 diabetic patients [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 336
Study Start Date: October 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSII
continuous subcutaneous insulin infusion
Drug: CSII
continuous subcutaneous insulin infusion for 2~4 weeks
Active Comparator: Metformin & Pioglitazone
CSII combined with metformin and pioglitazone
Drug: CSII, Metformin, Pioglitazone
CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
Active Comparator: Sitagliptin
CSII combined with sitagliptin 100mg/d
Drug: CSII, Sitagliptin
CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed type 2 diabetes
  • fasting blood glucose (FBG) level ranging from 7.0~16.7 mmol/L
  • body mass index (BMI) ranging from20~35kg/m2
  • Antihyperglycaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

  • having any severe acute or chronic diabetic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
  • • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
  • chronic or acute pancreatic disease
  • severe systematic diseases or malignant tumor
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance
  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: NCT01471808

Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Yanbin Li, MD Ministry of Education
  More Information

No publications provided

Responsible Party: Yanbing Li, the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01471808     History of Changes
Other Study ID Numbers: 13560475186
Study First Received: November 8, 2011
Last Updated: April 8, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Pioglitazone
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014