Clinical trial NCT00663884: Glufast On Insulin Glargine Trial in Type 2 DM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus, Type 2
mitiglinide
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 167
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change of HbA1c before and after administration of test drug
timeFrame: 20 weeks
Secondary outcomes:
measure: Change of self-monitoring of blood glucose before and after administration of test drug
timeFrame: 20 weeks
measure: Change of insulin dose before and after administration of test drug
timeFrame: 20 weeks
measure: Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)
timeFrame: 20 weeks
measure: Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
Study officials:
affiliation: The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital
name: Kun-ho Yoon
role: STUDY_CHAIR
References:
citation: Son JW, Lee IK, Woo JT, Baik SH, Jang HC, Lee KW, Cha BS, Sung YA, Park TS, Yoo SJ, Yoon KH. A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes. Endocr J. 2015;62(12):1049-57. doi: 10.1507/endocrj.EJ15-0325. Epub 2015 Sep 25.