A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917267
• Other study ID #: H8O-MC-GWCK
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2009
• Last updated: March 20, 2015
• Start date: July 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationIndia: Drugs Controller General of IndiaJapan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: April 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide once weekly
2.0mg subcutaneous injection, once a week
• exenatide twice daily
5mcg subcutaneous injection twice a day (4 weeks), 10mcg subcutaneous injection twice a day (22 weeks)

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Chengdu
China	Research Site	Chongqin
China	Research Site	Guangzhou
China	Research Site	Shanghai
India	Research Site	Ahmedabad
India	Research Site	Aligarh
India	Research Site	Bangalore
India	Research Site	Ghaziabad
India	Research Site	Hyderabaad
India	Research Site	Indore
India	Research Site	Kolkata
India	Research Site	Mumbai
India	Research Site	Pune
India	Research Site	Trivandrum
India	Research Site	Uttar Pradesh
India	Research Site	Varanasi
Japan	Research Site	Ageo
Japan	Research Site	Chiyoda-ku
Japan	Research Site	Izumisano
Japan	Research Site	Kashiwara
Japan	Research Site	Kitaazumi-gun
Japan	Research Site	Kumamoto
Japan	Research Site	Kurume
Japan	Research Site	Matsumoto
Japan	Research Site	Matsuyama
Japan	Research Site	Miyazaki-shi
Japan	Research Site	Ooita-shi
Japan	Research Site	Osaka
Japan	Research Site	Ota-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Takatsuki
Japan	Research Site	Yokohama
Korea, Republic of	Research Site	Bucheon
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Seoul
Taiwan	Research Site	Changhua
Taiwan	Research Site	Chia-Yi
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Countries where clinical trial is conducted

China,  India,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline to Week 26.	Change in HbA1c from baseline to Week 26.	Baseline, Week 26	No
Secondary	Percentage of Patients Achieving HbA1c Targets <=7% at Week 26	Percentage of patients achieving HbA1c <=7% at Week 26 (for patients with HbA1c >7% at baseline).	Baseline, Week 26	No
Secondary	Percentage of Patients Achieving HbA1c Targets <=6.5% at Week 26	Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline).	Baseline, Week 26	No
Secondary	Change in Fasting Serum Glucose (FSG) From Baseline to Week 26	Change in FSG from baseline to Week 26.	Baseline, Week 26	No
Secondary	Change in Body Weight (BW) From Baseline to Week 26	Change in BW from baseline to Week 26.	Baseline, Week 26	No
Secondary	Change in Total Cholesterol (TC) From Baseline to Week 26	Change in TC from baseline to Week 26.	Baseline, Week 26	No
Secondary	Change in High-Density Lipoprotein (HDL) From Baseline to Week 26	Change in HDL from baseline to Week 26.	Baseline, Week 26	No
Secondary	Ratio of Triglycerides (TG) at Week 26 to Baseline	Ratio of TG (measured in mg/dL) at Week 26 to baseline. Log(Post-baseline TG) - log(Baseline TG); change from baseline to Week 26 is presented as ratio of Week 26 to baseline.	Baseline, Week 26	No
Secondary	Change in Blood Pressure From Baseline to Week 26	Change in systolic blood pressure and diastolic blood pressure from baseline to Week 26.	Baseline, Week 26	No
Secondary	Assessment of Event Rate of Treatment-emergent Hypoglycemic Events	Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date. Mean and Standard Error were then derived from ITT.	Baseline to Week 26	Yes