Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects

Study Overview
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Brief Summary
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This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.

Detailed Description
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This clinical trial is a phase 2, double-blind dose escalation regimen of once-weekly OPK-88003 in subjects with T2DM. The trial consists of a screening/baseline (up to 2 weeks prior to first dose), treatment period consisting of a dose escalation (8 weeks) and a target dose (22 weeks), and a follow-up period (4 weeks). Subjects will be randomly assigned to volume-matched OPK-88003 or placebo administered QW.

Official Title
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A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: OPK-88003
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day), BMI ≥27 and ≤45 kg/m2 HbA1c ≥7.0% and ≤10.5% at screening Exclusion Criteria: Type 1 diabetes mellitus Previous treatment with incretin mimetic drugs Have used insulin for diabetic control for more than 6 consecutive days within the prior year Have had two or more emergency room visits or hospitalizations due to poor glucose control within the prior 6 months Have a history of acute or chronic pancreatitis or elevation in serum lipase/amylase (>2 x ULN).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate | Drug: Placebo<br>* Placebo subcutaneous injection<br>|
| Experimental: OPK-88003<br>70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks) | Drug: OPK-88003<br>* OPK-88003 subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c in Subjects With Type 2 DM | To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin. | From baseline to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent (%) Body Weight Change | Mean percent (%) body weight change from baseline to after 30 weeks treatment | From baseline to 30 weeks | 
| Percent (%) of Subjects With 5% or Greater Body Weight Loss. | Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment | 30 weeks. | 
| Change From Baseline of Fasting Plasma Glucose (FPG). | Change of FPG from baseline to after 30 weeks treatment | 30 weeks. |