Trial Outcomes & Findings for A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise (NCT NCT01095653)

NCT ID: NCT01095653

Last Updated: 2017-02-06

Results Overview

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1179 participants
• Primary outcome timeframe: From Baseline to Week 24
• Results posted on: 2017-02-06

Participant Flow

Of 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.

Participant milestones

Measure	Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Overall Study STARTED	132	128	133
Overall Study COMPLETED	113	113	117
Overall Study NOT COMPLETED	19	15	16

Reasons for withdrawal

Measure	Placebo Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Overall Study Lack of Efficacy	3	0	0
Overall Study Adverse Event	1	4	4
Overall Study Lost to Follow-up	1	0	4
Overall Study Withdrawal by Subject	4	5	3
Overall Study non-compliance, not met criteria, etc.	10	6	5

Baseline Characteristics

A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Baseline characteristics by cohort

Measure	Placebo n=132 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=128 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=133 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Total n=393 Participants Total of all reporting groups
Age, Customized 65 to younger than 75 years	11 Participants n=5 Participants	14 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Age, Customized 75 years and older	1 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Age, Continuous	49.9 Years STANDARD_DEVIATION 10.87 • n=5 Participants	53.0 Years STANDARD_DEVIATION 11.07 • n=7 Participants	51.2 Years STANDARD_DEVIATION 9.89 • n=5 Participants	51.3 Years STANDARD_DEVIATION 10.67 • n=4 Participants
Age, Customized Younger than 65 years	120 Participants n=5 Participants	108 Participants n=7 Participants	123 Participants n=5 Participants	351 Participants n=4 Participants
Sex/Gender, Customized Male	87 Participants n=5 Participants	84 Participants n=7 Participants	86 Participants n=5 Participants	257 Participants n=4 Participants
Sex/Gender, Customized Female	45 Participants n=5 Participants	44 Participants n=7 Participants	47 Participants n=5 Participants	136 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN INDIAN	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized CHINESE	117 Participants n=5 Participants	114 Participants n=7 Participants	117 Participants n=5 Participants	348 Participants n=4 Participants
Race/Ethnicity, Customized JAPANESE	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized KOREAN	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized ASIAN OTHER	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Weight	72.18 kg STANDARD_DEVIATION 13.234 • n=5 Participants	68.89 kg STANDARD_DEVIATION 11.429 • n=7 Participants	70.92 kg STANDARD_DEVIATION 11.637 • n=5 Participants	70.68 kg STANDARD_DEVIATION 12.177 • n=4 Participants
Body Mass Index (BMI)	25.93 kg/m^2 STANDARD_DEVIATION 3.644 • n=5 Participants	25.17 kg/m^2 STANDARD_DEVIATION 3.285 • n=7 Participants	25.76 kg/m^2 STANDARD_DEVIATION 3.434 • n=5 Participants	25.62 kg/m^2 STANDARD_DEVIATION 3.465 • n=4 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF)

HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period.

Outcome measures

Measure	Placebo n=127 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=122 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=127 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])	-0.29 % of hemoglobin Standard Error 0.0681	-1.04 % of hemoglobin Standard Error 0.0695	-1.11 % of hemoglobin Standard Error 0.0680

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period.

Outcome measures

Measure	Placebo n=131 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=127 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=128 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])	2.5 mg/dL Standard Error 2.237	-25.1 mg/dL Standard Error 2.274	-31.6 mg/dL Standard Error 2.255

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received study medication and had nonmissing PLMG values at baseline and Week 24 (LOCF)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Liquid Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period.

Outcome measures

Measure	Placebo n=105 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=100 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=105 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])	1.08 mg/dL Standard Error 4.5663	-46.8 mg/dL Standard Error 4.6559	-54.9 mg/dL Standard Error 4.5257

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period.

Outcome measures

Measure	Placebo n=132 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=128 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=128 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])	-0.27 kg Standard Error 0.2279	-1.64 kg Standard Error 0.2315	-2.25 kg Standard Error 0.2308

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF)

Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Mean and standard error for percentage of participants were estimated by modified logistic regression model.

Outcome measures

Measure	Placebo n=127 Participants Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=122 Participants Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=127 Participants Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])	21.3 Percentage of participants Standard Error 3.310	42.6 Percentage of participants Standard Error 4.300	49.8 Percentage of participants Standard Error 4.032

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Dapagliflozin 5 mg

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

Dapagliflozin 10 mg

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=132 participants at risk Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=128 participants at risk Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=133 participants at risk Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Congenital, familial and genetic disorders PYLORIC STENOSIS	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.75% 1/133 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Endocrine disorders GOITRE	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.78% 1/128 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.75% 1/133 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.75% 1/133 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations URETHRITIS	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.75% 1/133 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Nervous system disorders LACUNAR INFARCTION	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.75% 1/133 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	1.6% 2/128 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Cardiac disorders MYOCARDIAL INFARCTION	0.76% 1/132 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.78% 1/128 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	0.76% 1/132 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/128 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.78% 1/128 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.00% 0/132 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.78% 1/128 • Number of events 1 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	0.00% 0/133 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.

Other adverse events

Measure	Placebo n=132 participants at risk Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 5 mg n=128 participants at risk Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)	Dapagliflozin 10 mg n=133 participants at risk Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Metabolism and nutrition disorders HYPERLIPIDAEMIA	10.6% 14/132 • Number of events 14 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.8% 10/128 • Number of events 10 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.8% 9/133 • Number of events 9 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.1% 12/132 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	7.8% 10/128 • Number of events 10 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	6.8% 9/133 • Number of events 13 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Infections and infestations NASOPHARYNGITIS	3.8% 5/132 • Number of events 5 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	5.5% 7/128 • Number of events 8 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	3.0% 4/133 • Number of events 6 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
Metabolism and nutrition disorders DYSLIPIDAEMIA	5.3% 7/132 • Number of events 7 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	2.3% 3/128 • Number of events 3 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.	1.5% 2/133 • Number of events 2 • Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.

Additional Information

Anna Maria Langkilde

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place