A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

OPKO Health

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2944876; Drug: Exenatide extended-release; Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119819

15062

I7I-MC-XNAA (Other Identifier)

2013-003552-21 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Full description

The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Enrollment: 420 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women with diabetes mellitus Type 2
• Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
• Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Exclusion criteria

• Women of child bearing potential
• Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
• Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
• Participants with impaired renal function (serum creatinine >124 micromole per liter (µmol/L) [1.4 milligrams per deciliter (mg/dL)] in women, >133 µmol/L [1.5 mg/dL] in men)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 6 patient groups, including a placebo group

10 mg LY2944876

Experimental group

Description:

10 milligrams (mg) LY2944876 given subcutaneously (SC) once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: LY2944876

Drug: Metformin

15 mg LY2944876

Experimental group

Description:

15 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: LY2944876

Drug: Metformin

30 mg LY2944876

Experimental group

Description:

30 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: LY2944876

Drug: Metformin

50 mg LY2944876

Experimental group

Description:

50 mg LY2944876 given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: LY2944876

Drug: Metformin

Exenatide extended-release

Experimental group

Description:

2 mg exenatide extended-release given SC once weekly for 24 weeks. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: Exenatide extended-release

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo for LY2944876 and Exenatide given SC once weekly for 12 weeks. Participants assigned to placebo will have no injections during the second 12 weeks of the study. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry.

Treatment:

Drug: Placebo

Drug: Metformin