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

NCT ID: NCT01717911

Last Updated: 2012-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

Type 2 Diabetes

Keywords

Newly diagnosed type 2 diabetes; Insulin, metformin, sitagliptin; beta-cell function, glycemic control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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).

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.

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Humulin-N; Glucophage; Januvia

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Division of Endocrinology and Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harn-Shen Chen, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism

Locations

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Harn-Shen Chen, MD, PhD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 18556343 (View on PubMed)

Other Identifiers

NSC-2314-B-075-014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VGHIRB 201007016MB

Identifier Type: -

Identifier Source: org_study_id