Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients
2 other identifiers
interventional
436
1 country
1
Brief Summary
The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes-mellitus
Started Sep 2004
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 4, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedApril 1, 2008
October 1, 2007
3.1 years
September 4, 2005
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glycemic control, the improvement of β-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
Oct. 2007
Secondary Outcomes (1)
the effects of different interventions (oral anti-hyperglycemic agents, multiple daily injections and continuous subcutaneous insulin infusion) on glycemic control, β-cell function and the remission rate in newly-diagnosed type 2 diabetic patients
Oct. 2007
Study Arms (3)
CSII
ACTIVE COMPARATORPatients in continuous subcutaneous insulin infusion group received Human Insulin (Novolin-R, Novo Nordisk) with an insulin pump (H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland);
MDI
ACTIVE COMPARATORPatients in MDI group were treated with pre-meal Novolin-R, and Human Insulin NPH (Novolin-N, Novo Nordisk) at bedtime. Initial insulin doses were 0.4-0.5 IU/kg and total daily doses were divided into 50% of basal and 50% of bolus injection in CSII group and 30%-20%-20%-30% in multiple daily insulin injection group
OHA
ACTIVE COMPARATORIn oral hpoglycemic agents group, the patients with 20 kg/m2\<BMI≤25kg/m2 were initiated with Gliclazide (Diamicron, Servier) 80mg Bid (maximum to 160mg Bid), the patients with 25kg/m2\<BMI≤35kg/m2 were initiated with Metformin (Glucophage, BMS) 0.5 Bid (maximum to 2.0g/d), the combination of Diamicron and Glucophage was used in patients who could not achieve glycaemic control goal with one OHA or with FPG≥11.1mmol/l at randomization
Interventions
Eligibility Criteria
You may qualify if:
- informed consents be given before treatment
- the newly-diagnosed type 2 diabetic patients
- fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
- age ranging from 25～70 years old
- body mass index (BMI) ranging from20～35kg/m2
- never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents
You may not qualify if:
- having any severe acute or chronic complications
- renal dysfunction, blood creatinine≥150µmol/L
- blood aminotransferase level rising up(more than 2 times of the normal level)
- any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
- serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
- chronic or acute pancreatic disease
- severe systematic diseases or malignant tumor
- allergic to the drugs using in the trial
- any factors interfering the result
- female patients incline to be pregnant
- being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
- poor compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Ministry of Education, Chinacollaborator
- Guangdong Science and Technology Bureau, Chinacollaborator
- Hoffmann-La Rochecollaborator
- Novo Nordisk A/Scollaborator
Study Sites (1)
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510080, China
Related Publications (2)
Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. doi: 10.2337/diacare.27.11.2597.
PMID: 15504992BACKGROUNDWeng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.
PMID: 18502299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianping Weng, MD,PHD
Ministry of Education
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 4, 2005
First Posted
September 7, 2005
Study Start
September 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
April 1, 2008
Record last verified: 2007-10