Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-06-30

Brief Summary

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This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin

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Detailed Description

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Sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. Based on this assumption, this research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Sitagliptin

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

100mg P.O. per day for 1month

2

Glimepiride

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

2mg P.O. per day for 1 month

Interventions

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Sitagliptin

100mg P.O. per day for 1month

Intervention Type DRUG

Glimepiride

2mg P.O. per day for 1 month

Intervention Type DRUG

Other Intervention Names

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Januvia Glimel

Eligibility Criteria

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Inclusion Criteria

* patients with type 2 diabetes
* duration of diabetes less than 10 years
* HbA1c 6.5-8.0%
* BMI 20-30
* on stable dose of metformin (more than 1000mg) for at least 2 months

Exclusion Criteria

* having oral hypoglycemic agents other than metformin
* using insulin
* serum creatinin \>= 1.5 mg/dL
* SGOT, SGPT \>= 90
* ischemic heart disease
* congestive heart failure (NYHA class \>=2)
* severe diabetic complication (PDR, CRF, CVA)
* on medication affecting glucose profile (such as steroid)
* infectious disease
* malignancy
* pregnant or breast-feeding woman

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No