Clinical trial NCT00135330: An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Official title: An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
exenatide
rosiglitazone
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2005-08-26
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in ASIiAUC During a Hyperglycemic Clamp Test.
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in AUC for Glucose During a Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in Insulin Sensitivity Index as Measured by M-value.
timeFrame: Week 20
measure: Change in Insulin AUC in the First Stage From Baseline to Endpoint.
timeFrame: Week 20
measure: Change in Insulin iAUC From Baseline to Endpoint.
timeFrame: Week 20
measure: Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in AUC for C-peptide During a Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).
timeFrame: Week 20
measure: Change in HbA1c
timeFrame: Week 20
measure: Change in Fasting Serum Glucose Concentration.
timeFrame: Week 20
measure: Change in Fasting C-peptide
timeFrame: Week 20
measure: Change in Fasting Insulin
timeFrame: Week 20
measure: Change in Fasting Proinsulin
timeFrame: Week 20
measure: Change in Body Weight
timeFrame: Week 20
measure: Change in Fasting Total Cholesterol.
timeFrame: Week 20
measure: Change in Fasting HDL Cholesterol
timeFrame: Week 20
measure: Change in Fasting LDL Cholesterol
timeFrame: Week 20
measure: Change in Fasting Triglycerides
timeFrame: Week 20
measure: Change in Percent Body Fat During a Meal Challenge Test (MCT)
timeFrame: 20 weeks
measure: Change in Body Fat Mass During a Meal Challenge Test (MCT)
timeFrame: 20 weeks
measure: Change in Lean Body Mass During a Meal Challenge Test (MCT)
timeFrame: 20 weeks
measure: Change in Waist Circumference
timeFrame: 20 weeks
measure: Change in Hip Circumference
timeFrame: 20 weeks
measure: Change in Waist-to-hip Ratio
timeFrame: 20 weeks
measure: Incidence of Hypoglycemia Events
timeFrame: 20 weeks
measure: Hypoglycemia Rate Per 30 Days Per Patient
timeFrame: 20 weeks
measure: Pedal Edema Score
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: San Francisco
country: United States
facility: Research Site
state: California
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Honolulu
country: United States
facility: Research Site
state: Hawaii
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Pittsfield
country: United States
facility: Research Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Bronx
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Cincinatti
country: United States
facility: Research Site
state: Ohio
city: League City
country: United States
facility: Research Site
state: Texas
city: New Braunfels
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Renton
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: James Malone, MD
role: STUDY_DIRECTOR
References:
citation: Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
citation: DeFronzo RA, Triplitt C, Qu Y, Lewis MS, Maggs D, Glass LC. Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin. Diabetes Care. 2010 May;33(5):951-7. doi: 10.2337/dc09-1521. Epub 2010 Jan 27.