A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus (AWARD-CHN2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Sulfonylureas; Drug: Metformin; Drug: Dulaglutide; Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01648582

H9X-CR-GBDK (Other Identifier)

13439

Details and patient eligibility

About

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes mellitus for at least 6 months
• Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
• Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
• Adult men or adult non-pregnant, non-breastfeeding women
• Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)
• Stable weight (±5%) ≥3 months prior to screening

Exclusion criteria

• Have type 1 diabetes mellitus
• Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
• Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
• Have gastric emptying abnormality
• Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
• Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury[mmHg] or diastolic blood pressure above 95 mmHg)
• Have impaired liver function
• Have impaired kidney function
• Have history of chronic pancreatitis or acute pancreatitis
• Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)
• Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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774 participants in 3 patient groups

1.5 mg Dulaglutide

Experimental group

Description:

1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.

Treatment:

Drug: Dulaglutide

Drug: Sulfonylureas

Drug: Metformin

0.75 mg Dulaglutide

Experimental group

Description:

0.75 mg Dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea for up to 52 weeks. Participants are blinded to the dulaglutide dose.

Treatment:

Drug: Dulaglutide

Drug: Sulfonylureas

Drug: Metformin

Insulin Glargine

Active Comparator group

Description:

Insulin glargine administered based on fasting blood glucose concentrations per the dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea for up to 52 weeks.

Treatment:

Drug: Sulfonylureas

Drug: Metformin

Drug: Insulin glargine