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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-06-27

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.

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo subcutaneous injection

OPK-88003

70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)

Group Type EXPERIMENTAL

OPK-88003

Intervention Type DRUG

OPK-88003 subcutaneous injection

Interventions

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OPK-88003

OPK-88003 subcutaneous injection

Intervention Type DRUG

Placebo

Placebo subcutaneous injection

Intervention Type DRUG

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No