Comparison of the Effect of Exenatide versus Sitagliptin on 24-hour Average Glucose in Patients with Type 2 Diabetes on Metformin or a Thiazolidinedione

Study identifier:H8O-US-GWCV

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-hour Average Glucose in Patients with Type 2 Diabetes on Metformin or a Thiazolidinedione

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 4

Healthy volunteers

Study drug

exenatide, sitagliptin, placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Aug 2008

Primary Completion Date: 01 Oct 2009

Study Completion Date: 01 Oct 2009

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Inclusion Criteria

- Have type 2 diabetes
- Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
- Have a fasting glucose concentration <280 mg/dL at Visit 1
- Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
- Are between 18 and 70 years of age, inclusive.
- Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
- Have a history of stable body weight (not varying by >10% for at least
3 months prior to screening).
- Can swallow oral study drug capsule, without splitting or crushing.

Exclusion Criteria

- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
• Are breastfeeding.
• Test positive for pregnancy at the time of screening.
• Intend to become pregnant during the study.
• Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
- Treated with any of the following medications:
• Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
• Alpha-glucosidase inhibitor within 2 months of screening.
• Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
• Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
• Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
- Have a history of renal transplantation or are currently receiving renal
dialysis.
- Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
- Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
- Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have had organ transplantation.
- Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors
within the previous 3 months.
- Have received treatment within the last 30 days with a drug that has
not received regulatory approval for any indication at the time of study
entry.

No locations available

Arms	Assigned Interventions
Experimental: Sequence A	Drug: exenatide subcutaneous injection (5mcg or 10mcg), twice a day Other Name: Byetta Drug: sitagliptin oral administration (100mg), once a day in the morning Other Name: Januvia Drug: placebo subcutaneous injection (5mcg or 10mcg), twice a day Drug: placebo oral administration (100mg), once a day in the morning
Experimental: Sequence B	Drug: exenatide subcutaneous injection (5mcg or 10mcg), twice a day Other Name: Byetta Drug: sitagliptin oral administration (100mg), once a day in the morning Other Name: Januvia Drug: placebo subcutaneous injection (5mcg or 10mcg), twice a day Drug: placebo oral administration (100mg), once a day in the morning

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center null

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Chief Medical Officer