Clinical trial NCT00603239: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
Official title: Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
metformin
thiazolidinedione
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2008-01-29
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
* The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
* The metformin dose has been stable for at least 90 days
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
* Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2.

Exclusion Criteria:

* Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
* 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 screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
* Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
* Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
* Are currently treated with any of the following excluded medications:

  * Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
  * Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
  * Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
  * Pramlintide acetate injection within 3 months prior to screening
  * Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
  * 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

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c)
timeFrame: baseline and 26 weeks
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c <= 7%
timeFrame: 26 weeks
measure: Percentage of Patients Achieving HbA1c <= 6.5%
timeFrame: 26 weeks
measure: Change in Fasting Serum Glucose (FSG)
timeFrame: baseline and 26 weeks
measure: Change in Body Weight
timeFrame: baseline and 26 weeks
measure: Change in Waist Circumference
timeFrame: baseline and 26 weeks
measure: Change in Beta-cell Function
timeFrame: baseline and 26 weeks
measure: Change in Insulin Sensitivity.
timeFrame: baseline and 26 weeks
measure: Number of Subjects Who Experienced an Episode of Minor Hypoglycemia
timeFrame: 26 weeks
measure: Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score
timeFrame: baseline and 26 weeks
measure: Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score
timeFrame: baseline and 26 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Concord
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Mogadore
country: United States
facility: Research Site
state: Ohio
city: Corvallis
country: United States
facility: Research Site
state: Oregon
city: New Westminster
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Ajax
country: Canada
facility: Research Site
state: Ontario
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Celaya
country: Mexico
facility: Research Site
state: Guanajuato
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo Leon
city: Chihuahua
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Dolj
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Suceava
country: Romania
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Liutkus J, Rosas Guzman J, Norwood P, Pop L, Northrup J, Cao D, Trautmann M. A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin. Diabetes Obes Metab. 2010 Dec;12(12):1058-65. doi: 10.1111/j.1463-1326.2010.01251.x.
citation: Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.