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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OPK-88003
Placebo
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • National Research Institute - Huntington Park
  • National Research Institute - Wilshire
  • Clinical Pharmacology of Miami, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

OPK-88003

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 15, 2018
Last Updated
May 21, 2021
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03406377
Brief Title
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Official Title
A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Arm Title
OPK-88003
Arm Type
Experimental
Arm Description
70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)
Intervention Type
Drug
Intervention Name(s)
OPK-88003
Intervention Description
OPK-88003 subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo subcutaneous injection
Primary Outcome Measure Information:
Title
Change in HbA1c in Subjects With Type 2 DM
Description
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.
Time Frame
From baseline to 30 weeks
Secondary Outcome Measure Information:
Title
Mean Percent (%) Body Weight Change
Description
Mean percent (%) body weight change from baseline to after 30 weeks treatment
Time Frame
From baseline to 30 weeks
Title
Percent (%) of Subjects With 5% or Greater Body Weight Loss.
Description
Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment
Time Frame
30 weeks.
Title
Change From Baseline of Fasting Plasma Glucose (FPG).
Description
Change of FPG from baseline to after 30 weeks treatment
Time Frame
30 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Militza Vera De Alba, MD
Organizational Affiliation
OPKO Health, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Clinical Pharmacology of Miami, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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