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

Overview[ - collapse ][ - ]

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.
ConditionDiabetes Mellitus, Type 2
InterventionDrug: CSII
Drug: CSII, Metformin, Pioglitazone
Drug: CSII, Sitagliptin
PhasePhase 4
SponsorSun Yat-sen University
Responsible PartySun Yat-sen University
ClinicalTrials.gov IdentifierNCT01471808
First ReceivedNovember 8, 2011
Last UpdatedApril 8, 2013
Last verifiedApril 2013

Tracking Information[ + expand ][ + ]

First Received DateNovember 8, 2011
Last Updated DateApril 8, 2013
Start DateOctober 2011
Estimated Primary Completion DateDecember 2021
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleEffects of Different Early Intensive Therapies on Long-term β-cell Function
Official TitleEffects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionDiabetes Mellitus, Type 2
InterventionDrug: CSII
continuous subcutaneous insulin infusion for 2~4 weeks
Drug: CSII, Metformin, Pioglitazone
CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
Drug: CSII, Sitagliptin
CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months
Study Arm (s)
  • Active Comparator: CSII
    continuous subcutaneous insulin infusion
  • Active Comparator: Metformin & Pioglitazone
    CSII combined with metformin and pioglitazone
  • Active Comparator: Sitagliptin
    CSII combined with sitagliptin 100mg/d

Recruitment Information[ + expand ][ + ]

Recruitment StatusEnrolling by invitation
Estimated Enrollment336
Estimated Completion DateDecember 2021
Estimated Primary Completion DateDecember 2020
Eligibility 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
GenderBoth
Ages25 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01471808
Other Study ID Numbers13560475186
Has Data Monitoring CommitteeYes
Information Provided BySun Yat-sen University
Study SponsorSun Yat-sen University
CollaboratorsNot Provided
Investigators Principal Investigator: Yanbin Li, MD Ministry of Education
Verification DateApril 2013