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Clinical Trials/EUCTR2009-014841-10-GB
EUCTR2009-014841-10-GBActive, not recruitingPhase 1

The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3) - AWARD-3: Assessment of Weekly Administration of LY2189265 in Diabetes-3

Eli Lilly & Company - Indianapolis0 sites753 target enrollmentStarted: April 16, 2010Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
753
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •Patients diagnosed with type 2 diabetes for =3 months and =5 years, with a screening HbA1c =6.5% to =9.5%, and are
  • •1) treatment naïve
  • •2) not optimally treated with diet and exercise alone, and/or
  • •3) on 1 oral antihyperglycemic medication.
  • •Patients on oral antihyperglycemic medication (OAM) monotherapy must
  • •be on a dose =50% of the recommended maximum daily dose (per the local label) at Visit 1 for =3 months.
  • •See protocol for full details of inclusion criteria.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 753
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients who have type 1 diabetes; or who have been treated chronically with insulin therapy for the treatment of diabetes at any time in the past.
  • •See protocol for full details of exclusion criteria.

Investigators

Sponsor
Eli Lilly & Company - Indianapolis

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