NCT00324363

Brief Summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_3 type-2-diabetes-mellitus

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

February 23, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

May 9, 2006

Last Update Submit

February 20, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

exenatidediabetesAmylinLillyChina

Outcome Measures

Primary Outcomes (1)

  • To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.

    16 weeks

Secondary Outcomes (1)

  • To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements

    16 weeks

Study Arms (2)

Exenatide

EXPERIMENTAL

Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks

Drug: exenatide

Placebo

PLACEBO COMPARATOR

Placebo in volume equal to exenatide

Drug: Placebo

Interventions

exenatideDRUG

subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks

Also known as: Byetta
Exenatide
PlaceboDRUG

subcutaneous injection twice daily in volumes equal to exenatide

Placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy.
  • HbA1c between 7.1% and 11.0%, inclusive.
  • Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.

You may not qualify if:

  • Have participated in this study previously, or any other study using exenatide or GLP-1 analogs.
  • Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening.
  • Have characteristics contraindicating metformin or sulfonylurea use.
  • Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening.
  • Have used drugs for weight loss within 1 month of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Beijing, China

Location

Research Site

Guangzhou, China

Location

Research Site

Nanjing, China

Location

Research Site

Shanghai, China

Location

Research Site

Sichuan, China

Location

Research Site

Chennai, India

Location

Research Site

Mumbai, India

Location

Research Site

Pune, India

Location

Research Site

Seoul, South Korea

Location

Research Site

Sungnam City, South Korea

Location

Research Site

Chiayi City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 22236356DERIVED

  • Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J, Brodows R. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Res Clin Pract. 2009 Jan;83(1):69-76. doi: 10.1016/j.diabres.2008.09.037. Epub 2008 Nov 18.

    PMID: 19019476DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • James Malone, MD

    Eli Lilly and Company

    STUDY DIRECTOR

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

May 9, 2006

First Posted

May 11, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

February 23, 2015

Record last verified: 2015-01

Locations

IN(3)TW(4)CN(5)KR(2)