Phase 2 Completed N=113 Randomized Triple-blind Treatment

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

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT03406377 ↗

Enrolled (actual)

113

Serious AEs

9.7%

Results posted

Jun 2021

Primary outcomePrimary: Change in HbA1c in Subjects With Type 2 DM — -0.25; -1.47 mmols/mol

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in HbA1c in Subjects With Type 2 DM	-0.25; -1.47	—
SECONDARY Mean Percent (%) Body Weight Change	-2.10; -5.83	—
SECONDARY Percent (%) of Subjects With 5% or Greater Body Weight Loss.	16.7; 48.8	—
SECONDARY Change From Baseline of Fasting Plasma Glucose (FPG).	-13.3; -46.2	—

Eligibility Criteria

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).

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Data sourced from ClinicalTrials.gov (NCT03406377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.