A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin; Drug: LY2189265

Study type: Interventional

Funder types: Industry

Identifiers

NCT01075282

H9X-MC-GBDB (Other Identifier)

11374

Details and patient eligibility

About

The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.

Full description

Rescue therapy refers to 1 of 2 types of additional therapy, each given for a different reason: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.

Enrollment: 810 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)

  1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
  2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications

• Accept treatment with metformin and glimepiride throughout the study, as per protocol

• Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.

• Stable weight for 3 months prior to screening

• Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m^2)

• Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

Exclusion criteria

• Type 1 Diabetes
• HbA1c equal to or less than 6.5 at randomization
• Chronic insulin use
• Taking drugs to promote weight loss by prescription or over the counter
• Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
• History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
• Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
• Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
• Acute or chronic pancreatitis of any form
• Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
• History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
• A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
• Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
• History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
• Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
• Organ transplant except cornea
• Have enrolled in another clinical trial within the last 30 days
• Have previously signed an informed consent or participated in a LY2189265 study
• Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

810 participants in 3 patient groups

LY2189265 1.5 mg

Experimental group

Description:

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Treatment:

Drug: LY2189265

Drug: Glimepiride

Drug: Metformin

LY2189265 0.75 mg

Experimental group

Description:

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Treatment:

Drug: LY2189265

Drug: Glimepiride

Drug: Metformin

Insulin Glargine

Active Comparator group

Description:

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks Glimepiride: at least 4 mg/day, oral, for 78 weeks

Treatment:

Drug: Insulin Glargine

Drug: Glimepiride

Drug: Metformin