Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes acarbose alphaglucosidase prevention
Brief summary
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
Detailed description
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
Interventions
DRUGAcarbose
acarbose 100 mg PO once daily
DRUGPlacebo
acarbose placebo
Sponsors
Bayer
Indiana University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Fasting plasma glucose \<140 mg/dL * 75 g OGTT 2hr glucose \>120 mg/dL * BMI \> 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes * Age at least 25 years
Exclusion criteria
* Cancer within 5 years * Chronic infectious disease (HIV, Hepatitis) * CVD event within 6 months * Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control * elevated AST or ALT * Serum creatinine \>1.4 mg/dL (men) or \>1.3 mg/dL (women) * TG \>600 mg/dL * Known glucosidase intolerance * Inability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of fasting glucose >140 mg/dL | From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization | Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression. |
Countries
United States
Outcome results
None listed