Trial Outcomes & Findings for A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease (NCT NCT02512068)

NCT ID: NCT02512068

Last Updated: 2023-12-12

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

107 participants

Primary outcome timeframe

Baseline (Week 0) and end of Treatment Period I (Up to Week 12)

Results posted on

2023-12-12

Participant Flow

Participants took part in the study at 41 investigative sites in Japan, from 7 August 2015 to 24 April 2018.

Participants with a historical diagnosis of type 2 diabetes mellitus complicated by severe renal impairment or end stage renal disease (ESRD) were enrolled in one of the two treatment groups: trelagliptin 25 milligram (mg) throughout Period I and II, Placebo in Period I followed by trelagliptin 25 mg in Period II.

Participant milestones

Participant milestones
Measure	Trelagliptin 25 mg Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Overall Study STARTED	55	52
Overall Study COMPLETED	43	39
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Trelagliptin 25 mg Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Overall Study Pretreatment Event/Adverse Event	8	6
Overall Study Major Protocol Deviation	1	0
Overall Study Voluntary Withdrawal	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Reason Not Specified	3	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)	Total n=107 Participants Total of all reporting groups
Age, Continuous	65.8 Years STANDARD_DEVIATION 10.28 • n=55 Participants	65.8 Years STANDARD_DEVIATION 10.46 • n=52 Participants	65.8 Years STANDARD_DEVIATION 10.32 • n=107 Participants
Sex: Female, Male Female	17 Participants n=55 Participants	13 Participants n=52 Participants	30 Participants n=107 Participants
Sex: Female, Male Male	38 Participants n=55 Participants	39 Participants n=52 Participants	77 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Japan	55 Participants n=55 Participants	52 Participants n=52 Participants	107 Participants n=107 Participants
BMI	24.41 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.525 • n=55 Participants	24.97 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.017 • n=52 Participants	24.68 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.765 • n=107 Participants
Duration of Diabetes	239.7 Months STANDARD_DEVIATION 116.80 • n=55 Participants	219.3 Months STANDARD_DEVIATION 106.35 • n=52 Participants	229.8 Months STANDARD_DEVIATION 111.79 • n=107 Participants
Exercise Program Yes	13 Participants n=55 Participants	12 Participants n=52 Participants	25 Participants n=107 Participants
Exercise Program No	42 Participants n=55 Participants	40 Participants n=52 Participants	82 Participants n=107 Participants
Undergoing Hemodialysis Yes (End Stage Renal Disease)	40 Participants n=55 Participants	39 Participants n=52 Participants	79 Participants n=107 Participants
Undergoing Hemodialysis No (Severe Renal Impairment)	15 Participants n=55 Participants	13 Participants n=52 Participants	28 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6) Yes	35 Participants n=55 Participants	33 Participants n=52 Participants	68 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6) No	20 Participants n=55 Participants	19 Participants n=52 Participants	39 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Rapid-acting Insulin Secretagogue Yes	9 Participants n=55 Participants	8 Participants n=52 Participants	17 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Rapid-acting Insulin Secretagogue No	46 Participants n=55 Participants	44 Participants n=52 Participants	90 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Mitiglinide Calcium Hydrate	5 Participants n=55 Participants	3 Participants n=52 Participants	8 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Repaglinide	4 Participants n=55 Participants	5 Participants n=52 Participants	9 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): α-Glucosidase Inhibitor Yes	8 Participants n=55 Participants	12 Participants n=52 Participants	20 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): α-Glucosidase Inhibitor No	47 Participants n=55 Participants	40 Participants n=52 Participants	87 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Acarbose	0 Participants n=55 Participants	2 Participants n=52 Participants	2 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Miglitol	3 Participants n=55 Participants	2 Participants n=52 Participants	5 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Voglibose	5 Participants n=55 Participants	8 Participants n=52 Participants	13 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Insulin Preparation Yes	18 Participants n=55 Participants	13 Participants n=52 Participants	31 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Insulin Preparation No	37 Participants n=55 Participants	39 Participants n=52 Participants	76 Participants n=107 Participants
Antidiabetic Drug at the start of the screening period (Week -6): Type of Insulin Preparation Pre-Mixed	8 Participants n=17 Participants • The number analyzed is the number of participants with data available for analysis.	5 Participants n=12 Participants • The number analyzed is the number of participants with data available for analysis.	13 Participants n=29 Participants • The number analyzed is the number of participants with data available for analysis.
Antidiabetic Drug at the start of the screening period (Week -6): Type of Insulin Preparation Long-Acting	9 Participants n=17 Participants • The number analyzed is the number of participants with data available for analysis.	7 Participants n=12 Participants • The number analyzed is the number of participants with data available for analysis.	16 Participants n=29 Participants • The number analyzed is the number of participants with data available for analysis.
Creatinine Clearance	10.7 Milliliter (mL)/ minute (min) STANDARD_DEVIATION 8.32 • n=55 Participants	11.3 Milliliter (mL)/ minute (min) STANDARD_DEVIATION 8.29 • n=52 Participants	11.0 Milliliter (mL)/ minute (min) STANDARD_DEVIATION 8.27 • n=107 Participants
Estimated Glomerular Filtration Rate (eGFR)	8.3 mL/min/1.73 m^2 STANDARD_DEVIATION 7.28 • n=55 Participants	8.7 mL/min/1.73 m^2 STANDARD_DEVIATION 8.00 • n=52 Participants	8.5 mL/min/1.73 m^2 STANDARD_DEVIATION 7.61 • n=107 Participants
Hemoglobin A1c (HbA1c)	7.57 Percent STANDARD_DEVIATION 0.849 • n=55 Participants	7.74 Percent STANDARD_DEVIATION 1.049 • n=52 Participants	7.65 Percent STANDARD_DEVIATION 0.951 • n=107 Participants
Fasting Plasma Glucose	143.1 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 32.58 • n=55 Participants	151.1 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 39.30 • n=52 Participants	147.0 Milligram (mg)/deciliter (dL) STANDARD_DEVIATION 36.05 • n=107 Participants
Glycoalbumin	23.21 Percent STANDARD_DEVIATION 4.091 • n=55 Participants	24.29 Percent STANDARD_DEVIATION 4.565 • n=52 Participants	23.74 Percent STANDARD_DEVIATION 4.341 • n=107 Participants
Fasting C-Peptide	7.07 Nanogram (ng)/mL STANDARD_DEVIATION 5.481 • n=55 Participants	7.41 Nanogram (ng)/mL STANDARD_DEVIATION 4.580 • n=52 Participants	7.23 Nanogram (ng)/mL STANDARD_DEVIATION 5.042 • n=107 Participants
Fasting Glucagon	177.4 Picogram (pg)/mL STANDARD_DEVIATION 55.40 • n=55 Participants	165.7 Picogram (pg)/mL STANDARD_DEVIATION 38.13 • n=52 Participants	171.7 Picogram (pg)/mL STANDARD_DEVIATION 47.93 • n=107 Participants
Dipeptidyl-Peptidase-4 (DPP-4) Activity	8.4745 Nanomole(nmol)/min/mL STANDARD_DEVIATION 1.98793 • n=55 Participants	8.4200 Nanomole(nmol)/min/mL STANDARD_DEVIATION 2.04675 • n=52 Participants	8.4478 Nanomole(nmol)/min/mL STANDARD_DEVIATION 2.00754 • n=107 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and end of Treatment Period I (Up to Week 12)

Population: Full Analysis Set: All randomized participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Change From Baseline in HbA1c at the End of Treatment Period I	-0.71 Percent HbA1c Standard Error 0.087	0.01 Percent HbA1c Standard Error 0.089

PRIMARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.

An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II	40 Participants	32 Participants

PRIMARY outcome

Timeframe: Up to Week 54

Population: Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for "Trelagliptin 25 mg" group and events in Period II for "Placebo and Trelagliptin 25 mg" group, was analyzed.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=48 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet	54 Participants	48 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)

Population: Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.

Reported data was the change from baseline in HbA1c at each time point.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Changes From Baseline in HbA1c At Week 2	-0.24 Percent HbA1c Standard Deviation 0.274	0.05 Percent HbA1c Standard Deviation 0.260
Changes From Baseline in HbA1c At Week 4	-0.46 Percent HbA1c Standard Deviation 0.370	0.02 Percent HbA1c Standard Deviation 0.362
Changes From Baseline in HbA1c At Week 8	-0.64 Percent HbA1c Standard Deviation 0.556	-0.05 Percent HbA1c Standard Deviation 0.530
Changes From Baseline in HbA1c At Week 12	-0.73 Percent HbA1c Standard Deviation 0.576	0.03 Percent HbA1c Standard Deviation 0.740
Changes From Baseline in HbA1c At the End of Treatment Period I	-0.70 Percent HbA1c Standard Deviation 0.555	0.00 Percent HbA1c Standard Deviation 0.731
Changes From Baseline in HbA1c At the End of Treatment Period II	-0.76 Percent HbA1c Standard Deviation 0.824	-0.74 Percent HbA1c Standard Deviation 0.843

SECONDARY outcome

Timeframe: At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <6.0% at the End of Treatment Period I	3 Participants	2 Participants
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <6.0% at the End of Treatment Period II	7 Participants	8 Participants
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <7.0% at the End of Treatment Period I	22 Participants	7 Participants
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <7.0% at the End of Treatment Period II	22 Participants	18 Participants
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <8.0% at the End of Treatment Period I	10 Participants	5 Participants
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II HbA1c <8.0% at the End of Treatment Period II	11 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)

Reported data was the change from baseline in fasting plasma glucose at each time point.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Change From Baseline in Fasting Plasma Glucose At the End of Treatment Period II	-14.3 mg/dL Standard Deviation 37.48	-7.3 mg/dL Standard Deviation 34.31
Change From Baseline in Fasting Plasma Glucose At Week 2	-12.9 mg/dL Standard Deviation 22.67	2.3 mg/dL Standard Deviation 20.78
Change From Baseline in Fasting Plasma Glucose At Week 4	-11.3 mg/dL Standard Deviation 31.25	-2.6 mg/dL Standard Deviation 32.49
Change From Baseline in Fasting Plasma Glucose At Week 8	-12.7 mg/dL Standard Deviation 25.56	-4.3 mg/dL Standard Deviation 27.28
Change From Baseline in Fasting Plasma Glucose At Week 12	-15.9 mg/dL Standard Deviation 31.95	-0.3 mg/dL Standard Deviation 24.86
Change From Baseline in Fasting Plasma Glucose At the End of Treatment Period I	-14.8 mg/dL Standard Deviation 31.51	0.8 mg/dL Standard Deviation 25.50

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)

Reported data was the change from baseline in glycoalbumin at each time point.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Change From Baseline in Glycoalbumin At Week 2	-1.67 Percent Standard Deviation 1.137	0.10 Percent Standard Deviation 1.059
Change From Baseline in Glycoalbumin At Week 4	-2.46 Percent Standard Deviation 1.534	-0.01 Percent Standard Deviation 1.474
Change From Baseline in Glycoalbumin At Week 8	-2.69 Percent Standard Deviation 2.038	-0.21 Percent Standard Deviation 2.033
Change From Baseline in Glycoalbumin At Week 12	-2.85 Percent Standard Deviation 2.523	-0.27 Percent Standard Deviation 2.563
Change From Baseline in Glycoalbumin At the End of Treatment Period I	-2.81 Percent Standard Deviation 2.401	-0.15 Percent Standard Deviation 2.537
Change From Baseline in Glycoalbumin At the End of Treatment Period II	-3.12 Percent Standard Deviation 2.580	-3.06 Percent Standard Deviation 2.604

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.

Number of participants with a vital sign-related TEAE classified under the System Organ Class of "investigations," was reported.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.

Here "QTcF" is corrected QT interval by Fridericia formula.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=51 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II QTcF Interval >450 millisecond (msec)	13 Participants	16 Participants
Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II QTcF Interval >480 msec	3 Participants	5 Participants
Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II QTcF Interval >500 msec	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.

Here "U/L" is Unit/Litter, and "ULN" is Upper Limit of Normal.

Outcome measures

Outcome measures
Measure	Trelagliptin 25 mg n=55 Participants Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II)	Placebo and Trelagliptin 25 mg n=52 Participants Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II)
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II Amylase (U/L) >2×ULN	4 Participants	1 Participants
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II Lipase (U/L) >3×ULN	1 Participants	3 Participants

Adverse Events

Trelagliptin 25 mg

Serious events: 23 serious events

Other events: 48 other events

Deaths: 0 deaths

Placebo and Trelagliptin 25 mg

Serious events: 16 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Director

Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER