Glufast On Insulin Glargine Trial in Type 2 DM

Diabetes Mellitus, Type 2 Clinical Trial

— GLORIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663884
• Other study ID #: CWP-KAD-402
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: March 28, 2012
• Start date: February 2008
• Est. completion date: September 2009

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Mitiglinide
mitiglinide 10mg three times a day before a meal
• Voglibose
voglibose 0.2mg three times a day before a meal

Locations

Country	Name	City	State
Korea, Republic of	The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c before and after administration of test drug		20 weeks	No
Secondary	Change of self-monitoring of blood glucose before and after administration of test drug		20 weeks	No
Secondary	Change of insulin dose before and after administration of test drug		20 weeks	No
Secondary	Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)		20 weeks	No
Secondary	Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug		20 weeks	No