Glucose Reduction by Early Acarbose Treatment in Basal Insulin

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Voglibose (Basen); Drug: Acarbose (Glucobay, BAYG5421)

• Registration Number: NCT00970528
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Study Start: 2009-11
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Voglibose (Basen)	-
Arm 1	Acarbose (Glucobay, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbA1c)	Change from baseline to week 24, at week -2, 0, 8 and 24

Secondary Outcome Measures

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