Trial Outcomes & Findings for Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects (NCT NCT03406377)
NCT ID: NCT03406377
Last Updated: 2021-06-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
From baseline to 30 weeks
Results posted on
2021-06-15
Participant Flow
Participant milestones
| Measure |
Placebo
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
72
|
|
Overall Study
COMPLETED
|
25
|
51
|
|
Overall Study
NOT COMPLETED
|
16
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
Baseline characteristics by cohort
| Measure |
Placebo
n=41 Participants
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=72 Participants
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 Year
STANDARD_DEVIATION 9.06 • n=5 Participants
|
53.8 Year
STANDARD_DEVIATION 9.94 • n=7 Participants
|
55.1 Year
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to 30 weeksTo 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=45 Participants
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Change in HbA1c in Subjects With Type 2 DM
|
-0.25 mmols/mol
Standard Error 0.209
|
-1.47 mmols/mol
Standard Error 0.168
|
SECONDARY outcome
Timeframe: From baseline to 30 weeksMean percent (%) body weight change from baseline to after 30 weeks treatment
Outcome measures
| Measure |
Placebo
n=28 Participants
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=45 Participants
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Mean Percent (%) Body Weight Change
|
-2.10 Percentage of body weight change
Standard Error 0.976
|
-5.83 Percentage of body weight change
Standard Error 0.737
|
SECONDARY outcome
Timeframe: 30 weeks.Percent (%) of subjects with 5% or greater body weight loss after 30 weeks treatment
Outcome measures
| Measure |
Placebo
n=28 Participants
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=45 Participants
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Percent (%) of Subjects With 5% or Greater Body Weight Loss.
|
16.7 Percentage of participants
|
48.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 weeks.Change of FPG from baseline to after 30 weeks treatment
Outcome measures
| Measure |
Placebo
n=28 Participants
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=45 Participants
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Change From Baseline of Fasting Plasma Glucose (FPG).
|
-13.3 mg/dL
Standard Error 7.04
|
-46.2 mg/dL
Standard Error 5.86
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
OPK-88003
Serious events: 9 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=72 participants at risk
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Eye disorders
Branch retinal artery occlusion
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Eye disorders
Branch retinal artery occlusion account for peripheral vision loss right eye
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Hepatobiliary disorders
Acute cholelithiasis
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Immune system disorders
Hypersensitivity reaction
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Injury, poisoning and procedural complications
Right fibula fracture
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Injury, poisoning and procedural complications
Right distal tibia fracture
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Cardiac disorders
Non st-segment elevation myocardial infarction
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Infections and infestations
Acute diverticulitis
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Cecal volvulus s/p right hemicolectomy
|
2.4%
1/41 • 36 weeks
|
0.00%
0/72 • 36 weeks
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • 36 weeks
|
0.00%
0/72 • 36 weeks
|
|
Nervous system disorders
Acute toxic encephalopathy
|
2.4%
1/41 • 36 weeks
|
0.00%
0/72 • 36 weeks
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate
Placebo: Placebo subcutaneous injection
|
OPK-88003
n=72 participants at risk
70 mg/vial (extractable volume 1 mL)
OPK-88003: OPK-88003 subcutaneous injection
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • 36 weeks
|
38.9%
28/72 • 36 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • 36 weeks
|
26.4%
19/72 • 36 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
3/41 • 36 weeks
|
12.5%
9/72 • 36 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/41 • 36 weeks
|
1.4%
1/72 • 36 weeks
|
|
Investigations
Lipase increased
|
0.00%
0/41 • 36 weeks
|
2.8%
2/72 • 36 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place