Clinical trial NCT00935532: Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus
Official title: Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-07-09
Enrollment: 427
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: The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.


Eligibility criteria: Inclusion Criteria:

* present with type 2 diabetes mellitus
* HbA1c between 7.1% and 11.0% inclusive
* body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive
* treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion Criteria:

* Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
* Have been treated with drugs that promote weight loss within 90 days prior to study start.
* Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start.
* Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
* Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
* Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
* Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
* Have donated blood within 30 days prior to study start.

Primary outcomes:
measure: Change in HbA1c From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Subjects Achieving HbA1c<=7%
timeFrame: Baseline, Week 26
measure: Percentage of Subjects Achieving HbA1c<=6.5%
timeFrame: Baseline, Week 26
measure: Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Change in Body Weight From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Change in Total Cholesterol From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline
timeFrame: Baseline, Week 26
measure: Change in Blood Pressure From Baseline to Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
timeFrame: Baseline to Week 26
measure: Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
timeFrame: Baseline to Week 26
Other outcomes:
Locations:
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaragi
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.
citation: Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.