Conditions

Type 2 Diabetes Mellitus

Keywords

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, prestudy therapy (oral antihyperglycemic medication \[OAM\] yes/no), 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 (18)

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks
Baseline, 52 weeks
Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
Up to 26 and 52 weeks
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
Baseline, 26 weeks, 52 weeks
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Baseline, 26 weeks, 52 weeks
Change From Baseline in Body Weight at 26 Weeks and 52 Weeks
Baseline, 26 weeks, 52 weeks
+13 more secondary outcomes

Study Arms (3)

LY2189265

EXPERIMENTAL

Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.

Drug: LY2189265

Placebo/LY2189265

PLACEBO COMPARATOR

Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.

Drug: LY2189265Drug: Placebo

Liraglutide

ACTIVE COMPARATOR

Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.

Drug: Liraglutide

Interventions

LY2189265DRUG

Also known as: Dulaglutide

LY2189265Placebo/LY2189265

PlaceboDRUG

Placebo/LY2189265

LiraglutideDRUG

Liraglutide

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 before screening.
Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m\^2) to 35.0 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 been receiving more than half of the maximum dose of sulfonylureas at screening.
Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD 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.