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

NCT00729326 | Completed Phase 4 Results

• 1 other identifier: H8O-US-GWCV
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; exenatide; sitagliptin; Amylin; Lilly; metformin; thiazolidinedione

Outcome Measures

Primary Outcomes (1)

• Change in Time-averaged Glucose During a 24 Hour Period

  Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).

  baseline and 8 Weeks

Secondary Outcomes (18)

• Change in Two-hour Postprandial Glucose After the Morning Meal

  baseline and 8 Weeks

• Change in Fasting Blood Glucose After the Morning Meal

  baseline and 8 Weeks

• Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal

  baseline and 8 Weeks

• Change in Postprandial Glucagon AUC Excursion After the Morning Meal

  baseline and 8 Weeks

• Change in Postprandial Triglyceride AUC After the Morning Meal

  baseline and 8 Weeks

Study Arms (2)

Sequence A

EXPERIMENTAL

Drug: exenatide; Drug: sitagliptin; Drug: placebo

Sequence B

EXPERIMENTAL

Drug: exenatide; Drug: sitagliptin; Drug: placebo

Interventions

exenatide DRUG

subcutaneous injection (5mcg or 10mcg), twice a day

Also known as: Byetta

Sequence A; Sequence B

sitagliptin DRUG

oral administration (100mg), once a day in the morning

Also known as: Januvia

Sequence A; Sequence B

placebo DRUG

subcutaneous injection (5mcg or 10mcg), twice a day

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Chief Medical Officer, MD

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 9, 2015
• Results First Posted: January 20, 2011

Record last verified: 2015-03

Locations

US (1)