Effect of Exenatide, Sitagliptin or Glimepiride on Functional ß -Cell Mass

NCT00775684 · Completed

Last updated 2026-05-28

This clinical trial is testing whether the medications exenatide, sitagliptin, or glimepiride can affect the function of insulin-producing cells in people with pre-diabetes or type 2 diabetes over a 6-month period.

Status Completed The study has finished.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 47 people

Who can join Ages 18–70 · all sexes

Timeline Started 2008-10 · est. completion 2012-11

Where 3 sites · United States

What this study is testing ClinicalTrials.gov NCT00775684 ↗

Description as written by the study sponsor.

This study evaluates exenatide, sitagliptin, and glimepiride for the treatment of high blood sugar in patients with impaired fasting glucose or early type 2 diabetes. The purpose of this study is to determine if exenatide and sitagliptin increase the amount of insulin made by the pancreas compared to glimepiride. It is hypothesized that exenatide or sitagliptin will sustain or increase the amount of insulin made by the pancreas in comparison to glimepiride.

Treatments tested

Exenatide also known as Byetta® Drug

Exenatide (Byetta®)-5 µg injected subcutaneously twice daily and increased after 1 month to 10 µg twice daily as tolerated by gastrointestinal effects
Sitagliptin also known as Januvia® Drug

Sitagliptin (Januvia®)100 mg by mouth every morning
Glimepiride also known as Amaryl® Drug

Glimepiride (Amaryl®)-0.5 mg by mouth every morning and then increased by 0.5 - 1.0 mg at each monthly visit to achieve an average fasting glucose \< 110mg/dl

Main thing measured	Effect on Functional Beta-cell Mass as Determined by Change in ß-cell Secretory Capacity at 6 Months (μU/ml)
Sponsor	University of Pennsylvania
Conditions studied	Pre-diabetes, Type 2 Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00775684 ↗