NCT00622323

Brief Summary

This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

3 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

February 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

February 14, 2008

Last Update Submit

October 25, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetesexenatidemetforminsulfonylureaByettaAmylinLilly

Outcome Measures

Primary Outcomes (1)

  • To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide

    12 weeks

Secondary Outcomes (1)

  • To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.

    12 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients at least 18 years of age and diagnosed with type 2 diabetes mellitus treated in an ambulatory care setting and who are taking metformin, a sulfonylurea, or a combination of metformin and sulfonylurea, but have not achieved adequate glycemic control. Female patients eligible of becoming pregnant are required to have some form of contraception while participating in the study.

You may qualify if:

  • are male or female outpatients at least 18 years of age
  • provide written consent to the release of their data after being informed of the study
  • diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
  • are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
  • are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient

You may not qualify if:

  • are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
  • are currently taking insulin.
  • are pregnant or have intentions of becoming pregnant within the duration of the study.
  • are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Paranaque City, Philippines

Location

Research Site

Pasig, Philippines

Location

Research Site

Taytay, Philippines

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Chief Medical Officer, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

PH(3)