Clinical trial NCT00099619: Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
Official title: Efficacy of Exenatide Compared With Insulin Glargine in Patients With Type 2 Diabetes Using Metformin or Sulfonylurea for Whom Insulin is the Next Appropriate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: exenatide
exendin-4
diabetes
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2004-12-20
Enrollment: 138
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study with two treatment sequences and two treatment periods that will assess the safety and efficacy of exenatide treatment in patients with type 2 diabetes who have inadequate glycemic control using metformin or sulfonylurea and for whom insulin is the next appropriate step in diabetes treatment.


Eligibility criteria: Main Inclusion Criteria:

* Treated with a stable dose of metformin or sulfonylurea for at least 3 months prior to screening.
* HbA1c between 7.1% and 11.0%, inclusive.
* Insulin therapy should be the next appropriate step of diabetes treatment.
* Body Mass Index (BMI) \>25 kg/m2 and \<40 kg/m2.

Main Exclusion Criteria:

* Patient previously in a study involving exenatide or glucagon-like peptide-1 analogs.
* Treated with insulin, thiazolidinediones, alpha-glucosidase inhibitors, or meglitinides within 3 months prior to screening.

Primary outcomes:
measure: Change in HbA1c (glycosylated hemoglobin) from the baseline of the first period (16-weeks of exenatide or insulin) to the end of each 16-week period.
timeFrame: Baseline, Week 16, Week 32
Secondary outcomes:
measure: Change in patient-reported outcomes from Baseline to the end of each 16-week period
timeFrame: Baseline, Week 16, Week 32
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Daw Park
country: Australia
facility: Research Site
state: South Australia
city: Fullarton
country: Australia
facility: Research Site
state: South Australia
city: Box Hill
country: Australia
facility: Research Site
state: Victoria
city: East Ringwood
country: Australia
facility: Research Site
state: Victoria
city: Athens
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Veszprem
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: N.l.
city: Mexico City
country: Mexico
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
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.