Status:
COMPLETED
A Study for Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alon...
Eligibility Criteria
Inclusion
- Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
- Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
- Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
- Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
- Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m\^2) at screening
- Stable weight during the 3 months prior to screening.
Exclusion
- Use any antidiabetic agent other than metformin during the 2 months prior to screening.
- Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
- Are currently taking prescription or over-the counter medications to promote weight loss.
- Have been previously diagnosed with pancreatitis
- Women who are breastfeeding.
- Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
- Have poorly controlled hypertension
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00804986
Start Date
December 1 2008
End Date
January 1 2010
Last Update
July 14 2011
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bermuda Dunes, California, United States, 92203
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chula Vista, California, United States, 91911
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Huntington Beach, California, United States, 92648
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Long Beach, California, United States, 90806