Clinical trial NCT01470937: Early Diabetes Intervention Program
Official title: Early Diabetes Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes acarbose alphaglucosidase prevention
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2011-11-11
Enrollment: 219
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression of fasting glucose >140 mg/dL
timeFrame: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital GCRC
state: Indiana
Study officials:
affiliation: Indiana University
name: Kieren J Mather, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Robert V Considine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Marian S Kirkman, MD
role: STUDY_DIRECTOR
References:
citation: Kirkman MS, Shankar RR, Shankar S, Shen C, Brizendine E, Baron A, McGill J. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006 Sep;29(9):2095-101. doi: 10.2337/dc06-0061.
citation: Patel YR, Kirkman MS, Considine RV, Hannon TS, Mather KJ. Changes in Weight and Glucose Can Protect Against Progression in Early Diabetes Independent of Improvements in beta-Cell Function. J Clin Endocrinol Metab. 2016 Nov;101(11):4076-4084. doi: 10.1210/jc.2016-2056. Epub 2016 Aug 17.
citation: Hannon TS, Kirkman MS, Patel YR, Considine RV, Mather KJ. Profound defects in beta-cell function in screen-detected type 2 diabetes are not improved with glucose-lowering treatment in the Early Diabetes Intervention Program (EDIP). Diabetes Metab Res Rev. 2014 Nov;30(8):767-76. doi: 10.1002/dmrr.2553.