Clinical trial NCT00970528: Glucose Reduction by Early Acarbose Treatment in Basal Insulin
Official title: A Randomized, Parallel Group, Open-Label, Active-Controlled Study Comparing Acarbose With Voglibose in Patients Who Are Inadequately Controlled With Insulin Glargine Alone or in Combination With Metformin Based on Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Oral Hypoglycemic Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately controlled with insulin glargine alone or in combination with metformin.


Eligibility criteria: Inclusion Criteria:

* Aged 18-79 years
* Type 2 diabetes inadequately controlled with insulin glargine alone or in combination with metformin

  * Diagnosed of type 2 diabetes for at least 6 months prior to screening
  * Treated with tolerable, stable dose of insulin glargine and/or metformin for at least 3 months prior to screening
  * HbA1C \> 7.0 and \</= 10.0% at screening

Exclusion Criteria:

* Type 1 diabetes patients
* Myocardial infarction, unstable angina or coronary artery bypass surgery within previous 6 months
* Clinical evidence of active liver disease, or serum ALT or AST 3 times the upper limit of the normal (ULN) range
* Serum creatinine \>/= 1.5 mg/dl for males, \>/= 1.4 mg/dl for females
* Active proliferative diabetic retinopathy
* Any other anti-diabetic medications except insulin glargine and metformin within 4 weeks prior to study entry
* Gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesis, malabsorption syndrome, chronic diarrhea states, enteropathies, inflammatory bowel disease, partial intestinal obstruction, and large hernias)
* Galactose intolerance
* Pregnancy
* Delivery, abortion, or lactation within less than three cycles before the start of treatment
* No use of contraceptive in childbearing aged. Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) since signing of the informed consent form until at least 30 days after the last study drug administration.
* Hypersensitivity to the active substances or any of gradient of the study drug ingredients
* Treatment with any medication including corticosteroid or herb medication that can affect blood glucose level in the 3 months prior to study entry
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study

Primary outcomes:
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: Change from baseline to week 24, at week -2, 0, 8 and 24
Secondary outcomes:
measure: Self monitoring blood glucose concentration
timeFrame: 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24)
measure: Fasting blood glucose concentration
timeFrame: At week -2, 0, 4, 8, 16 and 24
measure: Blood concentration of triglyceride
timeFrame: At week -2 and 24
measure: Blood concentration of low density lipoprotein
timeFrame: At week -2 and 24
measure: Blood concentration of total cholesterol
timeFrame: At week -2 and 24
measure: Blood concentration of high density lipoprotein
timeFrame: At week -2 and 24
measure: Blood concentration of apolipoprotein A-1
timeFrame: At week -2 and 24
measure: Blood concentration of apolipoprotein B
timeFrame: At week -2 and 24
measure: Blood concentration of Glucagon-like peptide-1 (GLP-1)
timeFrame: At week -0 and 24
measure: Body weight, Body Mass Index(BMI)
timeFrame: At week -2, 0, 4, 8, 16 and 24
measure: High Sensitivity C-reactive protein (hs-CRP)
timeFrame: At week -2 and 24
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
state: Gang''weondo
city: Busan
country: Korea, Republic of
state: Korea
city: Gyeonggi-do
country: Korea, Republic of
state: Korea
city: Gyeonggi-do
country: Korea, Republic of
state: Korea
city: Pusan
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Daegu
country: Korea, Republic of
city: Jeonju-si
country: Korea, Republic of
city: Seongbuk-gu Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Lee MY, Choi DS, Lee MK, Lee HW, Park TS, Kim DM, Chung CH, Kim DK, Kim IJ, Jang HC, Park YS, Kwon HS, Lee SH, Shin HK. Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study. J Korean Med Sci. 2014 Jan;29(1):90-7. doi: 10.3346/jkms.2014.29.1.90. Epub 2013 Dec 26.