ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes
InterventionDrug: Insulin
Drug: Metformin
Drug: Sitagliptin
PhasePhase 4
SponsorTaipei Veterans General Hospital, Taiwan
Responsible PartyTaipei Veterans General Hospital, Taiwan
ClinicalTrials.gov IdentifierNCT01717911
First ReceivedOctober 28, 2012
Last UpdatedOctober 28, 2012
Last verifiedJuly 2010

Tracking Information[ + expand ][ + ]

First Received DateOctober 28, 2012
Last Updated DateOctober 28, 2012
Start DateSeptember 2010
Estimated Primary Completion DateDecember 2018
Current Primary Outcome MeasuresThe primary outcome was the comparison of A1C change. [Time Frame: Dec. 2013] [Designated as safety issue: No]The primary outcome was the comparison of A1C change.
Current Secondary Outcome MeasuresBeta-cell function and insulin sensitivity and the proportion of subjects who reached the treatment target (A1C <7.0% or <6.5% at 6 months). [Time Frame: Dec 2013] [Designated as safety issue: No]The secondary efficacy analysis was the beta-cell function and insulin sensitivity calculated from OGTT and the proportion of subjects who reached the treatment target (A1C <7.0% or <6.5% at 6 months).

Descriptive Information[ + expand ][ + ]

Brief Titleß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia
Official Titleß-Cell Function and Glycemic Control of Basal Insulin, Metformin or Sitagliptin in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia
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.
Detailed Description
ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects
responsible for the development of hyperglycemia. There is a progressive deterioration in
ß-cell function and mass in type 2 diabetics. Optimal metabolic control, especially early
intensive glycemic control, plays a role in the prevention of progressive ß-cell dysfunction
and possibly destruction of the ß-cells with worsening of diabetes.

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.

This study also can assess what readily available parameter would predict which patients
will achieve long-term successful glycemic control after correction of glucose toxicity.

Our results will provide evidence that a 6-month course of basal insulin therapy could
shorten the exposure to moderate hyperglycemia and further improve beta-cell function to
achieve long-term glycemic control.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Insulin
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.
Other Names:
Humulin-NDrug: Metformin
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).
Other Names:
GlucophageDrug: Sitagliptin
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.
Other Names:
Januvia
Study Arm (s)
  • Active Comparator: Metformin
    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).
  • Experimental: Sitagliptin
    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.
  • Experimental: Insulin
    In 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment160
Estimated Completion DateDecember 2018
Estimated Primary Completion DateDecember 2013
Eligibility Criteria
Inclusion Criteria:

1. Recently diagnosed type 2 diabetic patients.

2. Fasting plasma glucose between 200-300 mg/dl (A1C level between 7% and 10%).

3. Those who age between 30 and 80 years old and can inject insulin by themselves.

Exclusion Criteria:

1. Previous treated with anti-diabetic medication

2. Pregnant or nursing women.

3. Impaired liver function (ALT > 120 U/L)

4. Impaired renal function (Serum creatinine >1.5 mg/dL in male, >1.4 mg/dL in female )

5. Recently suffered from MI or CVA.

6. Patients are acute intercurrent illness.

7. 2-hour C-peptide level < 1.8 ng/mL.
GenderBoth
Ages30 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesTaiwan

Administrative Information[ + expand ][ + ]

NCT Number NCT01717911
Other Study ID NumbersVGHIRB 201007016MB
Has Data Monitoring CommitteeNo
Information Provided ByTaipei Veterans General Hospital, Taiwan
Study SponsorTaipei Veterans General Hospital, Taiwan
CollaboratorsNot Provided
Investigators Principal Investigator: Harn-Shen Chen, MD, Phd Division of Endocrinology and Metabolism
Verification DateJuly 2010

Locations[ + expand ][ + ]

Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Contact: Harn-Shen Chen, MD, PhD | 886-2-28757515 | chenhs@vghtpe.gov.tw
Principal Investigator: Harn-Shen Chen, MD, PhD
Recruiting