Trial Outcomes & Findings for A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone (NCT NCT02419612)

NCT ID: NCT02419612

Last Updated: 2020-06-23

Results Overview

To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

444 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2020-06-23

Participant Flow

A total of 444 subjects were randomized in this international, multi-center study which was conducted at 88 centers in 10 countries between 14 Aug 2015 and 18 September 2019.

The study duration was up to 160 weeks, consisting of a 2-week screening period, 2-week lead-in period, 52-week short-term treatment period, and 104-week long-term treatment period (156-week treatment period). One subject did not start the short-term treatment period and so only 443 subjects received treatment.

Participant milestones

Participant milestones
Measure	Dapagliflozin 10mg and Saxagliptin 5mg Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day	Titrated Glimepiride Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
Short-term Treatment Period STARTED	227	217
Short-term Treatment Period Recevied Treatment	227	216
Short-term Treatment Period COMPLETED	210	194
Short-term Treatment Period NOT COMPLETED	17	23
Long-term Treatment Period STARTED	196	186
Long-term Treatment Period Received Treatment	196	183
Long-term Treatment Period COMPLETED	174	164
Long-term Treatment Period NOT COMPLETED	22	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapagliflozin 10mg and Saxagliptin 5mg Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day	Titrated Glimepiride Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
Short-term Treatment Period Adverse Event	1	1
Short-term Treatment Period Death	0	2
Short-term Treatment Period Lost to Follow-up	6	6
Short-term Treatment Period Withdrawal by Subject	9	9
Short-term Treatment Period Subject Request To Discontinue Treatment	1	1
Short-term Treatment Period Non-compliance with Study Drug	0	2
Short-term Treatment Period Worsening of liver function	0	1
Short-term Treatment Period Subject moved out of state	0	1
Long-term Treatment Period Non-compliance with Study Drug	1	1
Long-term Treatment Period Lost to Follow-up	6	4
Long-term Treatment Period Lack of Efficacy	1	1
Long-term Treatment Period Death	0	1
Long-term Treatment Period Adverse Event	0	5
Long-term Treatment Period Other	4	4
Long-term Treatment Period Subject Decision	2	4
Long-term Treatment Period Withdrawal by Subject	8	2

Baseline Characteristics

A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Total n=443 Participants Total of all reporting groups
Age, Continuous	56.1 Years STANDARD_DEVIATION 10.11 • n=5 Participants	56.1 Years STANDARD_DEVIATION 9.23 • n=7 Participants	56.1 Years STANDARD_DEVIATION 9.68 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	115 Participants n=7 Participants	225 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	101 Participants n=7 Participants	218 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	206 Participants n=5 Participants	196 Participants n=7 Participants	402 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=212 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=218 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52	-0.98 % HbA1c Interval -1.12 to -0.84	-1.35 % HbA1c Interval -1.49 to -1.22

SECONDARY outcome

Timeframe: Baseline and Week 52

To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=214 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=224 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Change From Baseline in Total Body Weight at Week 52	0.95 kilogram (kg) Interval 0.38 to 1.51	-3.11 kilogram (kg) Interval -3.65 to -2.57

SECONDARY outcome

Timeframe: At Week 52

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.

Therapeutic glycemic response was defined as HbA1c \<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 52 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52	34.3 Percentage of subjects Interval 27.87 to 41.33	44.3 Percentage of subjects Interval 37.45 to 51.32

SECONDARY outcome

Timeframe: Baseline and Week 52

To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=214 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=224 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Change From Baseline in Systolic Blood Pressure (SBP) at Week 52	1.0 mmHg Interval -0.9 to 2.9	-2.6 mmHg Interval -4.4 to -0.8

SECONDARY outcome

Timeframe: Up to Week 52

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after the 52-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 52 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 52-week short -term treatment period.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Percentage of Subjects With Treatment Intensification During the 52-week Short-term Treatment Period	8.8 Percentage of Subjects	1.3 Percentage of Subjects

SECONDARY outcome

Timeframe: Up to Week 156

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. The values presented are the percentage of subjects requiring the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control during the 156-week treatment period.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Percentage of Subjects With Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.	55.6 Percentage of Subjects	37.0 Percentage of Subjects

SECONDARY outcome

Timeframe: At Week 156

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.

Therapeutic glycemic response was defined as HbA1c \<7.0%. Subjects rescued or discontinued prior to, and subjects with missing measurements at Week 156 were treated as non-responders. The percentage of subjects with a therapeutic glycemic response is based on the logistic regression method with adjustment for baseline HbA1c.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Percentage of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 156	11.7 Percentage of Subjects Interval 8.03 to 16.82	21.4 Percentage of Subjects Interval 16.3 to 27.64

SECONDARY outcome

Timeframe: Up to Week 156

Population: The randomized subject data set included all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.

Treatment intensification was defined as the addition of insulin or other glucose-lowering agent for rescue therapy or discontinuation for lack of glycemic control. Time to treatment intensification was censored after 156-week treatment period if treatment intensification had not occurred by then. Subjects rescued at Week 156 were counted as having an event for the analysis. Time to treatment intensification curves were generated using Kaplan-Meier estimates and compared using a Cox proportional hazards model.

Outcome measures

Outcome measures
Measure	Titrated Glimepiride n=216 Participants Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.	Dapagliflozin 10mg and Saxagliptin 5mg n=227 Participants Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day
Time to Treatment Intensification During the 156-Week Short-term Plus Long-Term Treatment Period.	92.3 Weeks Interval 73.0 to 105.7	NA Weeks Not calculable as less than 50% of the subjects took rescue therapy or discontinued for lack of glycemic control before Week 156.

Adverse Events

Dapagliflozin 10mg and Saxagliptin 5mg

Serious events: 29 serious events

Other events: 99 other events

Deaths: 1 deaths

Titrated Glimepiride

Serious events: 24 serious events

Other events: 106 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Dapagliflozin 10mg and Saxagliptin 5mg n=227 participants at risk Subjects received dapagliflozin 10 mg, saxagliptin 5 mg plus placebo for glimepiride, each administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day	Titrated Glimepiride n=216 participants at risk Subjects received titrated glimepiride 1, 2, 3, 4, or 6 mg plus placebo for saxagliptin and placebo for dapagliflozin, administered orally once daily. Subjects also continued to receive their metformin dose of at least 1500 mg per day.
Infections and infestations Upper respiratory tract infection	10.1% 23/227 • Number of events 29 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	9.7% 21/216 • Number of events 27 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Nervous system disorders Headache	7.9% 18/227 • Number of events 21 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	7.4% 16/216 • Number of events 20 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Vascular disorders Hypertension	3.1% 7/227 • Number of events 7 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	8.3% 18/216 • Number of events 18 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Infections and infestations Bronchitis	4.8% 11/227 • Number of events 15 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	7.9% 17/216 • Number of events 21 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Infections and infestations Influenza	4.0% 9/227 • Number of events 10 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	5.6% 12/216 • Number of events 16 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Infections and infestations Nasopharyngitis	6.2% 14/227 • Number of events 20 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	8.8% 19/216 • Number of events 25 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Infections and infestations Pharyngitis	2.6% 6/227 • Number of events 9 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	5.6% 12/216 • Number of events 13 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Infections and infestations Urinary tract infection	13.7% 31/227 • Number of events 41 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	9.7% 21/216 • Number of events 28 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Metabolism and nutrition disorders Dyslipidaemia	0.88% 2/227 • Number of events 2 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	6.0% 13/216 • Number of events 14 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Gastrointestinal disorders Diarrhoea	4.4% 10/227 • Number of events 11 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	5.6% 12/216 • Number of events 13 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.
Musculoskeletal and connective tissue disorders Back pain	5.3% 12/227 • Number of events 16 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.	3.2% 7/216 • Number of events 8 • All adverse events (AEs), including serious adverse events (SAEs), were collected on or after the date of first dose of short-term study medication and up to and including 4 days (other AEs) or 30 days (SAEs) after last dose. Up to a total of 160 weeks. The treated subjects data set for the short-tem plus long-term treatment period consisted of all subjects who received at least 1 dose of double-blind study medication during the short-term double-blind treatment period.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: +1 877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place