Conditions

Type 2 Diabetes Mellitus

Keywords

Glucagon-like peptide-1 (GLP-1)

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Baseline, 26 weeks

Secondary Outcomes (5)

Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
Up to 26 weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
Baseline, 26 weeks
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Baseline, Up to 26 weeks
Change From Baseline in Body Weight at 26 Weeks
Baseline, 26 weeks
Percentage of Participants With Hypoglycemic Episodes
Baseline through 26 Weeks

Study Arms (2)

LY2189265 + OAM

EXPERIMENTAL

LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Drug: LY2189265Drug: Sulfonylureas (SU)Drug: Biguanide (BG)

Insulin glargine + OAM

ACTIVE COMPARATOR

Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).

Drug: Insulin glargineDrug: Sulfonylureas (SU)Drug: Biguanide (BG)

Interventions

LY2189265DRUG

Also known as: Dulaglutide

LY2189265 + OAM

Insulin glargineDRUG

Insulin glargine + OAM

Sulfonylureas (SU)DRUG

Insulin glargine + OAMLY2189265 + OAM

Biguanide (BG)DRUG

Insulin glargine + OAMLY2189265 + OAM

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening
Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable
Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening
Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2)

You may not qualify if:

Participants who have a diagnosis of type 1 diabetes
Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog
Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening
Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening
Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening
Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)

Contact the study team to confirm eligibility.