Clinical trial NCT01717911: ß-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia
Official title: ß-Cell Function and Glycemic Control of Basal Insulin, Metformin or Sitagliptin in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Newly diagnosed type 2 diabetes
Insulin, metformin, sitagliptin
beta-cell function, glycemic control
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2012-10-31
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary outcome was the comparison of A1C change.
timeFrame: Dec. 2013
Secondary outcomes:
measure: 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).
timeFrame: Dec 2013
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Division of Endocrinology and Metabolism
name: Harn-Shen Chen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.