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

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OPKO Health

Status and phase

Completed
Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo
Drug: OPK-88003

Study type

Interventional

Funder types

Industry

Identifiers

NCT03406377
DPO-203

Details and patient eligibility

About

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.

Full description

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.

Enrollment

113 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

113 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Treatment:
Drug: Placebo
OPK-88003
Experimental group
Description:
70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)
Treatment:
Drug: OPK-88003

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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