Glufast On Insulin Glargine Trial in Type 2 DM - Full Text View

Sponsor:	JW Pharmaceutical
Information provided by:	JW Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00663884

Purpose

We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Mitiglinide Drug: Voglibose	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Randomized and Multi-center Clinical Study to Evaluate Efficacy and Safety of Combination Therapy of Mitiglinide or Voglibose With Long-acting Insulin in Type 2 Diabetic Patients

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin Voglibose Mitiglinide

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:

Change of HbA1c before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of self-monitoring of blood glucose before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Change of insulin dose before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Enrollment:	167
Study Start Date:	February 2008
Study Completion Date:	September 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: M Mitiglinide	Drug: Mitiglinide mitiglinide 10mg three times a day before a meal Other Name: Glufast
Active Comparator: V Voglibose	Drug: Voglibose voglibose 0.2mg three times a day before a meal Other Name: Basen

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The type 2 diabetic patients aged between 30 and 70
The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
Outpatients whose BMI is between 21 and 40 kg/㎡
The patients who consented to participate in the clinical study in writing

Exclusion Criteria:

The patients who have been using insulin formulation except insulin glargine
The patients whose fasting blood glucose is over 270 mg/dL
The patients whose C-peptide is under 1ng/ml on an empty stomach
The patients who was surgically operated of gastrointestinal tract
The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
The patients with unstable angina or acute myocardial infarction occurred within 3months
The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment
The patients who have a life-threatening disease such as cancer or severe infection
The patients with a history of drug allergy
Pregnant or breast feeding or the women who are likely to be pregnant
The patients who need oral or parenteral corticosteroids
The patients who were judged to be unsuitable to the clinical study by other reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663884

Locations

Korea, Republic of
The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
Seoul, #505 Banpo-dong Seocho-gu, Korea, Republic of, 137-701

Sponsors and Collaborators

JW Pharmaceutical

Investigators

Study Chair:

Kun-ho Yoon

The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

More Information

No publications provided

Responsible Party:	Keun Lee / Senior Staff, Clinical Research Department
ClinicalTrials.gov Identifier:	NCT00663884 History of Changes
Other Study ID Numbers:	CWP-KAD-402
Study First Received:	April 18, 2008
Last Updated:	October 18, 2010
Health Authority:	South Korea: Institutional Review Board

Keywords provided by JW Pharmaceutical:

diabetes mellitus, Type 2
mitiglinide

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Mitiglinide
Voglibose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012