Clinical trial NCT00917267: A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
Official title: A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
once weekly
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-06-10
Enrollment: 691
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies have suggested that a once-weekly formulation of exenatide may provide sustained glycemic control. These previous studies of exenatide once weekly have been conducted in non-Asian populations, so this study has been developed to support the local regulatory requirements of China, Korea, Japan, India, and Taiwan.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 2 diabetes.
* Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11.0% inclusive.
* Have a body mass index (BMI) of \>21 kg/m2 and \<35 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 90 days prior to study start).
* Have been treated with a stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD, or SU plus TZD for at least 90 days prior to study start.

Exclusion Criteria:

* Have any contraindication for the OAD(s) that they use.
* Have a known allergy or hypersensitivity to exenatide BID, exenatide QW, or excipients contained in these agents.
* Have received chronic \>14 consecutive days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption.
* Have been treated with drugs that promote weight loss (for example, GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days of study start.
* Have been treated for \>2 weeks with any of the following excluded medications within 90 days prior to study start:

  * Insulin
  * Dipeptidyl peptidase (DPP)-4 inhibitors (for example, sitagliptin or vildagliptin)
  * Pramlintide acetate
  * Drugs that directly affect gastrointestinal motility, including, but not limited to: Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics.
* Have had prior exposure to exenatide
* Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW.
* 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.
* Are currently enrolled in any other clinical study.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 26.
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Patients Achieving HbA1c Targets <=7% at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26
timeFrame: Baseline, Week 26
measure: Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Body Weight (BW) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Total Cholesterol (TC) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in High-Density Lipoprotein (HDL) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Ratio of Triglycerides (TG) at Week 26 to Baseline
timeFrame: Baseline, Week 26
measure: Change in Blood Pressure From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Assessment of Event Rate of Treatment-emergent Hypoglycemic Events
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqin
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Aligarh
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Ghaziabad
country: India
facility: Research Site
city: Hyderabaad
country: India
facility: Research Site
city: Indore
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
city: Uttar Pradesh
country: India
facility: Research Site
city: Varanasi
country: India
facility: Research Site
city: Ageo
country: Japan
facility: Research Site
city: Chiyoda-ku
country: Japan
facility: Research Site
city: Izumisano
country: Japan
facility: Research Site
city: Kashiwara
country: Japan
facility: Research Site
city: Kitaazumi-gun
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kurume
country: Japan
facility: Research Site
city: Matsumoto
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Miyazaki-shi
country: Japan
facility: Research Site
city: Ooita-shi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Takatsuki
country: Japan
facility: Research Site
city: Yokohama
country: Japan
facility: Research Site
city: Bucheon
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Chia-Yi
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer Officer, MD
role: STUDY_DIRECTOR
References:
citation: Onishi Y, Koshiyama H, Imaoka T, Haber H, Scism-Bacon J, Boardman MK. Safety of exenatide once weekly for 52 weeks in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Mar 18;4(2):182-9. doi: 10.1111/jdi.12000. Epub 2012 Oct 22.
citation: Ji L, Onishi Y, Ahn CW, Agarwal P, Chou CW, Haber H, Guerrettaz K, Boardman MK. Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Jan 29;4(1):53-61. doi: 10.1111/j.2040-1124.2012.00238.x. Epub 2012 Sep 14.