Study Purpose:
ADOPT (A Diabetes Outcome Progression Trial)
is a randomized, double-blind study to compare the
durability of glucose lowering and the preservation of pancreatic beta-cell
function of rosiglitazone monotherapy with metformin or glyburide/glibenclamide
in patients with drug-naïve, recently-diagnosed type 2 diabetes mellitus.
ADOPT is testing the hypothesis that rosiglitazone preserves
pancreatic beta-cell function better than other drugs used as first line
therapy for type 2 diabetes mellitus, thus delaying or preventing deterioration
in glycemic control. Pancreatic beta-cell function will be assessed by an
oral glucose tolerance test.
Rosiglitazone is an
insulin-sensitizing drug, a new class of drugs that help insulin to work better
in patients with type 2 diabetes. Because of it insulin-sensitizing action,
rosiglitazone may preserve pancreatic beta-cell function better than
other first line drugs for type 2 diabetes mellitus.
Study Design:
Patients
recently diagnosed (<2 years) with type 2 diabetes who were eligible and had
no exclusions were asked to participate in ADOPT.
A 4-week trial of diet/exercise was utilized to identify
those patients who remain insufficiently controlled (FPG
>=126mg/dL
and
<=180mg/dL
[7-10 mmol/L]). Such patients were eligible to be randomized to one of
three treatments: (1) rosiglitazone, (2) glyburide or glibenclamide, or (3)
metformin. Treatment was double-blind
and lasted for approximately four years or until monotherapy failure, i.e.,
when fasting plasma glucose was confirmed to be >180 mg/dL.
Study Subjects and
Recruitment:
Men and women, aged 30-75
years with type 2 diabetes mellitus diagnosed <two years before screening
and managed without drug therapy were eligible for further screening. Patients who had fasting plasma glucose
values between 126 and 240 mg/dL were eligible for a four-week run-in with
life-style interventions (diet and exercise).
At the end of the run-in, participants who had fasting plasma glucose
values between 126 and 180 mg/dL were eligible for randomization to one of the
three drug limbs. About 300 centers in
North America and Europe participated In ADOPT with each trying to recruit 12
patients for a total of 3,600 patients.
To account for dropout rates, the recruitment numbers were increased to
4,182. Recruitment closed on June 28, 2002 with 4,380 randomized
worldwide. The Columbia-Cornell
Clinical Trials Network did an outstanding job recruiting for ADOPT. Five clinical sites in our network
participated: Columbia University Health Sciences, Albert Einstein College of
Medicine/Jacobi Hospital, Cooper Health Care System, Diabetes Care and Information
Center of New York, and Cornell Internal Medicine Associates. Together our five sites randomized 132
participants, more than twice their collective goal of 60 participants. Columbia University Health Sciences and
Albert Einstein/Jacobi Hospital ranked first and second worldwide in terms of
recruitment with 45 and 39 participants, respectively.
Follow-up
Follow-up
in ADOPT is expected to continue until about June 2006.
