Glucose Reduction by Early Acarbose Treatment in Basal Insulin (GREAN)

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Bayer

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Acarbose (Glucobay, BAYG5421)
Drug: Voglibose (Basen)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970528
14081

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 2 patient groups

Arm 1
Experimental group
Treatment:
Drug: Acarbose (Glucobay, BAYG5421)
Arm 2
Active Comparator group
Treatment:
Drug: Voglibose (Basen)

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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