A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus (AWARD-CHN1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo as SC Injection; Drug: Glimepiride; Drug: Placebo as Capsules; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644500

11991

H9X-JE-GBCG (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

Enrollment: 737 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• OAM-naïve or have been taking OAM monotherapy for at least 3 months
• Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy
• Adult men or adult non-pregnant, non-breastfeeding women
• Stable weight (±5%) ≥3 months prior to screening
• Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m^2)

Exclusion criteria

• Have type 1 diabetes mellitus
• Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
• Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
• 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 millimeters 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 picogram/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: Triple Blind

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737 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 plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.

Treatment:

Drug: Dulaglutide

Drug: Placebo as Capsules

0.75 mg Dulaglutide

Experimental group

Description:

0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.

Treatment:

Drug: Dulaglutide

Drug: Placebo as Capsules

Glimepiride

Active Comparator group

Description:

1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.

Treatment:

Drug: Placebo as SC Injection

Drug: Glimepiride