Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

NCT00577824 | Completed Phase 3 Results

• 1 other identifier: H8O-JE-GWBB
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 12

Brief Summary

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Conditions

Type 2 Diabetes

Keywords

diabetes; exenatide; LY2148568; Byetta; Lilly; Amylin

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

  Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

  baseline, 24 weeks

Secondary Outcomes (16)

• Percentage of Patients Achieving HbA1c < 7.0%

  24 weeks

• Percentage of Patients Achieving HbA1c < 6.5%

  24 weeks

• Change in Fasting Blood Glucose

  baseline, week 24

• Change in Body Weight

  baseline, week 24

• Change in Total Cholesterol

  baseline, week 24

Study Arms (3)

1

EXPERIMENTAL

Drug: exenatide

2

EXPERIMENTAL

Drug: exenatide

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

exenatide DRUG

subcutaneous injection, 5mcg, twice a day

Also known as: LY2148568, Byetta

1

placebo DRUG

subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

3

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes.
• Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
• Have HbA1c 7.0% to 10% at study start.
• Have a body weight \>=50 kg.

You may not qualify if:

• 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.
• Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
• Have been treated with any exogenous insulin within 90 days before study start.
• Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
• The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Sponsors & Collaborators

• AstraZeneca: lead
• Eli Lilly and Company: collaborator

Study Sites (12)

Research Site

Chiba, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Fukushima, Japan

Location

Research Site

Hyōgo, Japan

Location

Research Site

Ibaraki, Japan

Location

Research Site

Kanagawa, Japan

Location

Research Site

Kumamoto, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Nagano, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Ōita, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (3)

• Kadowaki T, Namba M, Imaoka T, Yamamura A, Goto W, Boardman MK, Sowa H. Improved glycemic control and reduced bodyweight with exenatide: A double-blind, randomized, phase 3 study in Japanese patients with suboptimally controlled type 2 diabetes over 24 weeks. J Diabetes Investig. 2011 Jun 5;2(3):210-7. doi: 10.1111/j.2040-1124.2010.00084.x.

  PMID: 24843486 RESULT

• Inagaki N, Ueki K, Yamamura A, Saito H, Imaoka T. Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes. J Diabetes Investig. 2011 Nov 30;2(6):448-56. doi: 10.1111/j.2040-1124.2011.00137.x.

  PMID: 24843529 RESULT

• 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.

  PMID: 22913891 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Peter Ohman, Medical Science Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Chief Medical Officer, MD

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 9, 2015
• Results First Posted: December 31, 2009

Record last verified: 2015-03

Locations

JP (12)