Glucose Reduction by Early Acarbose Treatment in Basal Insulin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Acarbose (Glucobay, BAYG5421)
* Drug: Voglibose (Basen)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acarbose (Glucobay, BAYG5421)<br>* uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin<br>|
| Active Comparator: Arm 2<br> | Drug: Voglibose (Basen)<br>* uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1c) |  | Change from baseline to week 24, at week -2, 0, 8 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self monitoring blood glucose concentration |  | 6 points for 2 days prior to each visit (at week 0, 4, 8, 16 and 24) | 
| Fasting blood glucose concentration |  | At week -2, 0, 4, 8, 16 and 24 | 
| Blood concentration of triglyceride |  | At week -2 and 24 | 
| Blood concentration of low density lipoprotein |  | At week -2 and 24 | 
| Blood concentration of total cholesterol |  | At week -2 and 24 | 
| Blood concentration of high density lipoprotein |  | At week -2 and 24 | 
| Blood concentration of apolipoprotein A-1 |  | At week -2 and 24 | 
| Blood concentration of apolipoprotein B |  | At week -2 and 24 | 
| Blood concentration of Glucagon-like peptide-1 (GLP-1) |  | At week -0 and 24 | 
| Body weight, Body Mass Index(BMI) |  | At week -2, 0, 4, 8, 16 and 24 | 
| High Sensitivity C-reactive protein (hs-CRP) |  | At week -2 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Hypoglycemic Agent