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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406377
Recruitment Status : Completed
First Posted : January 23, 2018
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: OPK-88003 Drug: Placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind Dose Escalation Regimen of Once-Weekly OPK-88003 in Subjects With Type 2 Diabetes
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
 Drug: Placebo
Placebo subcutaneous injection
Experimental: OPK-88003
70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks)
 Drug: OPK-88003
OPK-88003 subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406377


Locations
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United States, California
National Research Institute - Huntington Park
Huntington Park, California, United States, 90255
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
United States, Florida
Clinical Pharmacology of Miami, LLC
Hialeah, Florida, United States, 33014
Sponsors and Collaborators
OPKO Health, Inc.
Investigators
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Study Director: Militza Vera De Alba, MD OPKO Health, Inc.
  Study Documents (Full-Text)

Documents provided by OPKO Health, Inc.:
Study Protocol  [PDF] October 9, 2018
Statistical Analysis Plan  [PDF] February 4, 2019

More Information
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT03406377    
Other Study ID Numbers: DPO-203
First Posted: January 23, 2018    Key Record Dates
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021
Last Verified: May 2021

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases