An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: exenatide; Drug: rosiglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00135330

H8O-US-GWAY

Details and patient eligibility

About

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Enrollment: 137 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c of 6.8% to 10.0%, inclusive.
• Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion criteria

• Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors

• Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.

• Treated with any of the following medications:

  • Thiazolidinedione within 5 months of screening;
  • Sulfonylurea within 3 months of screening;
  • Metformin/sulfonylurea combination therapy within 3 months of screening;
  • Alpha-glucosidase inhibitor within 3 months of screening;
  • Meglitinide within 3 months of screening;
  • Insulin for more than 1 week within the 3 months prior to screening.
  • Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
  • Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
  • Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
  • Systemic antineoplastic agent
  • Systemic transplantation medication
  • Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 3 patient groups

Exenatide Arm

Experimental group

Treatment:

Drug: exenatide

Exenatide plus Rosiglitazone Arm

Experimental group

Treatment:

Drug: rosiglitazone

Drug: exenatide

Rosiglitazone Arm

Experimental group

Treatment:

Drug: rosiglitazone