Phase 2 N=21 Randomized Quadruple-blind Treatment

Beta-Cell Function and Sitagliptin Trial (BEST)

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00420511 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

Dec 2011

Primary outcome: Primary: Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR — 80.4; 71.2 index of beta-cell function

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sitagliptin (Drug); Placebo (Drug); metformin (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Preservation of Beta-cell Function Measured by Area-under-the-curve (C-peptide/Glucose)/HOMA-IR	80.4; 71.2	—
SECONDARY Insulinogenic Index Divided by HOMA-IR at 48 Weeks	3.9; 1.8	—
SECONDARY Fasting Blood Glucose at 48 Weeks	6.9; 6.7	—
SECONDARY Area-under-the-glucose-curve (AUCglucose) on Meal Test at 1 Year	—	—
SECONDARY Time to Loss of Glycemic Control	—	—
SECONDARY Proportion of Patients Achieving Sustained Normoglycemia Off Medication at 1-week Post-insulin Therapy	—	—

Summary

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin. Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.

Eligibility Criteria

Inclusion Criteria

Men and women between the ages of 30 and 75 inclusive
Physician-diagnosed type 2 diabetes on 0-2 oral hypoglycemic agents
Negative for anti-glutamic acid decarboxylase (anti-GAD\_ antibodies (to rule out Latent Autoimmune Diabetes of Adults (LADA)
A1c at screening between 6.5% and 9% inclusive if on no oral hypoglycemic agents or 6.0% and 9.0% inclusive if on 1-2 oral hypoglycemic agents

Exclusion Criteria

Current insulin therapy
Type 1 diabetes or secondary forms of diabetes
Any major illness with a life expectancy of /= 136 umol/L for males or >/= 124 umol/L for females or abnormal creatinine clearance ( 2.5 times the upper limit of normal
Excessive alcohol consumption, defined as > 14 alcoholic drinks per week for males and > 9 alcoholic drinks per week for females
Pregnancy or unwillingness to use reliable contraception. Women should not be planning pregnancy for the duration of the study. Reliable contraception includes: birth control pill, intra-uterine device, abstinence, tubal ligation, partner vasectomy, or condoms with spermicide. Any women who miss a menstrual period or think that they may be pregnant must have a pregnancy test as soon as possible
History of serious arrhythmia or atrioventricular block on baseline electrocardiogram
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
Unwillingness to undergo multiple daily insulin injection therapy for 4 weeks
Unwillingness to perform capillary blood glucose monitoring at least 4 times per day during intensive insulin therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00420511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.