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) - GBDC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014841-10-DE

Enrollment

753

Registered

2010-02-19

Start date

2010-07-01

Completion date

Unknown

Last updated

2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus MedDRA version: 13.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: LY2189265 Product Code: LY2189265 Pharmaceutical Form: Solution for injection Current Sponsor code: LY2189265 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to demonstrate that once-weekly LY2189265 (1.5 mg) injected subcutaneously, is non-inferior to metformin on HbA1c change from baseline at 6 months in patients with type 2 diabetes mellitus.;Secondary Objective: The following key secondary objectives will compare glycemic control (as measured by change in HbA1c from baseline) between LY2189265 (1.5 mg and 0.75 mg) and metformin: • To demonstrate that LY2189265 1.5 mg is superior to metformin at 26 weeks. • To demonstrate that LY2189265 0.75 mg is noninferior to metformin at 26 weeks. • To demonstrate that LY2189265 0.75 mg is superior to metformin at 26 weeks. See protocol for list of additional secondary objectives.;Primary end point(s): The endpoint for the primary analysis is defined as the change from baseline in HbA1c at 26 weeks.	—

Measure

Time frame

Main Objective: The primary objective is to demonstrate that once-weekly LY2189265 (1.5 mg) injected subcutaneously, is non-inferior to metformin on HbA1c change from baseline at 6 months in patients with type 2 diabetes mellitus.;Secondary Objective: The following key secondary objectives will compare glycemic control (as measured by change in HbA1c from baseline) between LY2189265 (1.5 mg and 0.75 mg) and metformin: • To demonstrate that LY2189265 1.5 mg is superior to metformin at 26 weeks. • To demonstrate that LY2189265 0.75 mg is noninferior to metformin at 26 weeks. • To demonstrate that LY2189265 0.75 mg is superior to metformin at 26 weeks. See protocol for list of additional secondary objectives.;Primary end point(s): The endpoint for the primary analysis is defined as the change from baseline in HbA1c at 26 weeks.

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Countries

Czech Republic, Finland, France, Germany, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026