ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia
2 other identifiers
interventional
160
1 country
1
Brief Summary
We have found that a 6-month course of insulin therapy after a short-term intensive insulin therapy could shorten the period of hyperglycemia to preserve ß-cell function and further improve long-term glycemic control in recently diagnosed type 2 diabetes with severe hyperglycemia (\>300 mg/dl, with HBA1C level around 9-11%) in our previous study. We thus hypothesized that a 6-month course of basal insulin therapy could also help to preserve ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300 mg/dl). This prospective study is outpatient-based to evaluate whether 6-month basal insulin therapy versus oral anti-diabetic treatment (Metformin and sitagliptin) soon after the diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with better ß-cell function reservation. We skip a short-term intensive admission course of insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe hyperglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started Sep 2010
Longer than P75 for phase_4 type-2-diabetes
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, 2010
CompletedFirst Submitted
Initial submission to the registry
October 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedOctober 31, 2012
July 1, 2010
3.3 years
October 28, 2012
October 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome was the comparison of A1C change.
The primary outcome was the comparison of A1C change.
Dec. 2013
Secondary Outcomes (1)
Beta-cell function and insulin sensitivity and the proportion of subjects who reached the treatment target (A1C <7.0% or <6.5% at 6 months).
Dec 2013
Study Arms (3)
Metformin
ACTIVE COMPARATORThe titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).
Sitagliptin
EXPERIMENTALThe subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was \<70mg /dl, discontinued the study if blood glucose was still \<70mg/dl under sitagliptin 50mg per day.
Insulin
EXPERIMENTALIn the insulin therapy group (Insulin glargine), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Daily dose was administrated before breakfast.
Interventions
In the insulin therapy group (Humulin-N), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Two third daily dose was administrated before breakfast and one third at bedtime. Insulin doses were titrated every 3 days to achieve target fasting plasma glucose values between 90 and 130 mg/dl.
The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).
The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was \<70mg /dl, discontinued the study if blood glucose was still \<70mg/dl under sitagliptin 50mg per day.
Eligibility Criteria
You may qualify if:
- Recently diagnosed type 2 diabetic patients.
- Fasting plasma glucose between 200-300 mg/dl (A1C level between 7% and 10%).
- Those who age between 30 and 80 years old and can inject insulin by themselves.
You may not qualify if:
- Previous treated with anti-diabetic medication
- Pregnant or nursing women.
- Impaired liver function (ALT \> 120 U/L)
- Impaired renal function (Serum creatinine \>1.5 mg/dL in male, \>1.4 mg/dL in female )
- Recently suffered from MI or CVA.
- Patients are acute intercurrent illness.
- hour C-peptide level \< 1.8 ng/mL.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, Taiwan, 11217, Taiwan
Related Publications (1)
Chen HS, Wu TE, Jap TS, Hsiao LC, Lee SH, Lin HD. Beneficial effects of insulin on glycemic control and beta-cell function in newly diagnosed type 2 diabetes with severe hyperglycemia after short-term intensive insulin therapy. Diabetes Care. 2008 Oct;31(10):1927-32. doi: 10.2337/dc08-0075. Epub 2008 Jun 12.
PMID: 18556343BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harn-Shen Chen, MD, Phd
Division of Endocrinology and Metabolism
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division of Endocrinology and Metabolism
Study Record Dates
First Submitted
October 28, 2012
First Posted
October 31, 2012
Study Start
September 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2018
Last Updated
October 31, 2012
Record last verified: 2010-07