Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)
This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01769378
First received: January 14, 2013
Last updated: May 14, 2013
Last verified: May 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 14, 2013 | ||||
| Last Updated Date | May 14, 2013 | ||||
| Start Date ICMJE | January 2013 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01769378 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8) | ||||
| Official Title ICMJE | A Randomized, Parallel-Arm, Double-Blinded Study Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Patients With Type 2 Diabetes Mellitus on Sulfonylurea Therapy (AWARD-8: Assessment of Weekly AdministRation of LY2189265 in Diabetes - 8) | ||||
| Brief Summary | The purpose of this study is to assess the efficacy and safety of once-weekly dulaglutide compared to placebo in participants with type 2 diabetes who have inadequate glycemic control with sulfonylurea monotherapy. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 285 | ||||
| Estimated Completion Date | August 2014 | ||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States, Argentina, Austria, Brazil, Croatia, Mexico, Romania, Slovenia, South Africa | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01769378 | ||||
| Other Study ID Numbers ICMJE | 13193, H9X-MC-GBDG | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eli Lilly and Company | ||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Eli Lilly and Company | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||