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Completed

NCT Number: NCT03406377

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Research Institute - Huntington Park, Huntington Park, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

OPK-88003

Drug

OPK-88003 subcutaneous injection

Placebo

Drug

Placebo subcutaneous injection

Primary outcomes

  1. Change in HbA1c in Subjects With Type 2 DM

    Time frame: From baseline to 30 weeks

    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.

Secondary outcomes

  1. Mean Percent (%) Body Weight Change

    Time frame: From baseline to 30 weeks

    Mean percent (%) body weight change from baseline to after 30 weeks treatment

  2. Percent (%) of Subjects With 5% or Greater Body Weight Loss.

    Time frame: 30 weeks.

    Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment

  3. Change From Baseline of Fasting Plasma Glucose (FPG).

    Time frame: 30 weeks.

    Change of FPG from baseline to after 30 weeks treatment

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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