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

This study is currently recruiting participants.
Verified July 2010 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01717911
First received: October 28, 2012
Last updated: NA
Last verified: July 2010
History: No changes posted
  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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Insulin
Drug: Metformin
Drug: Sitagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ß-Cell Function and Glycemic Control of Basal Insulin, Metformin or Sitagliptin in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • The 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.


Secondary Outcome Measures:
  • 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). [ 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).


Estimated Enrollment: 160
Study Start Date: September 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).
Other Name: Glucophage
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.
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.
Other Name: Januvia
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.
Drug: 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 Name: Humulin-N

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717911

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Harn-Shen Chen, MD, PhD    886-2-28757515    chenhs@vghtpe.gov.tw   
Principal Investigator: Harn-Shen Chen, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Harn-Shen Chen, MD, Phd Division of Endocrinology and Metabolism
  More Information

Publications:
Responsible Party: vghtpe user, Division of Endocrinology and Metabolism, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT01717911     History of Changes
Other Study ID Numbers: VGHIRB 201007016MB, NSC-2314-B-075-014
Study First Received: October 28, 2012
Last Updated: October 28, 2012
Health Authority: Taipei Veterans General Hospital, Taipei: Taiwan

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Newly diagnosed type 2 diabetes
Insulin, metformin, sitagliptin
beta-cell function, glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014