A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Biguanides (BG); Drug: Glinides; Drug: Thiazolidinedione (TZD); Drug: Sulfonylureas (SU); Drug: alpha-glucosidase inhibitor (a-GI); Drug: LY2189265

Study type: Interventional

Funder types: Industry

Identifiers

NCT01468181

13991

H9X-JE-GBDQ (Other Identifier)

Details and patient eligibility

About

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

Enrollment: 394 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who have had a diagnosis of type 2 diabetes mellitus before screening
• Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
• Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening
• Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)

Exclusion criteria

• 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 within the 3 months before screening
• Participants who are currently taking insulin or have had previous insulin treatment within the 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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394 participants in 5 patient groups

LY2189265 + Sulfonylureas (SU)

Experimental group

Description:

LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.

Treatment:

Drug: LY2189265

Drug: Sulfonylureas (SU)

LY2189265 + Biguanides (BG)

Experimental group

Description:

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.

Treatment:

Drug: LY2189265

Drug: Biguanides (BG)

LY2189265 + alpha-glucosidase inhibitor (a-GI)

Experimental group

Description:

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.

Treatment:

Drug: LY2189265

Drug: alpha-glucosidase inhibitor (a-GI)

LY2189265 + Thiazolidinedione (TZD)

Experimental group

Description:

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.

Treatment:

Drug: Thiazolidinedione (TZD)

Drug: LY2189265

LY2189265 + Glinides

Experimental group

Description:

LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.

Treatment:

Drug: LY2189265

Drug: Glinides