A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: exenatide and placebo
Drug: exenatide and sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00870194
H8O-CR-GWDK

Details and patient eligibility

About

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Enrollment

255 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Present with type 2 diabetes

  • Patients have been treated with a stable dose of the following for at least 3 months prior to screening:

    • 100 mg/day sitagliptin and
    • ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
  • Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.

  • Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2

Exclusion criteria

  • Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

  • Have previously completed or withdrawn from this study or any other study investigating exenatide.

  • Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.

  • Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.

  • Are currently treated with any of the following excluded medications:

    • Thiazolidinediones (TZD) within 3 months of screening.
    • Sulfonylurea (SU) within 3 months of screening.
    • Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
    • Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
    • Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
    • Exogenous insulin within the 3 months prior to screening.
    • Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
    • Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
    • Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

255 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: exenatide and sitagliptin
2
Placebo Comparator group
Treatment:
Drug: exenatide and placebo

Trial contacts and locations

36

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems