Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone (NCT NCT02284893)
NCT ID: NCT02284893
Last Updated: 2018-06-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
Baseline (randomization) to Week 26
Results posted on
2018-06-01
Participant Flow
461 Patients were Randomized into the study, 411 patients completed the 26 weeks part. Out of them 402 patients continued into the additional 26 week part. Out of them 378 patients completed the 52 weeks period (26+26 weeks).
Participant milestones
| Measure |
SAXA + DAPA + MET
Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
|
SITA + MET
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
26 Week (Short Term)
STARTED
|
232
|
229
|
|
26 Week (Short Term)
COMPLETED
|
213
|
198
|
|
26 Week (Short Term)
NOT COMPLETED
|
19
|
31
|
|
52 Week (Long Term)
STARTED
|
209
|
193
|
|
52 Week (Long Term)
COMPLETED
|
198
|
180
|
|
52 Week (Long Term)
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
SAXA + DAPA + MET
Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
|
SITA + MET
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
26 Week (Short Term)
Adverse Event
|
1
|
9
|
|
26 Week (Short Term)
Discontinuation by the subject
|
2
|
2
|
|
26 Week (Short Term)
Withrawal of the consent by the subject
|
7
|
10
|
|
26 Week (Short Term)
Lost to Follow-up
|
3
|
1
|
|
26 Week (Short Term)
Subject no longer meets study criteria
|
5
|
8
|
|
26 Week (Short Term)
Other
|
1
|
1
|
|
52 Week (Long Term)
Adverse Event
|
3
|
1
|
|
52 Week (Long Term)
Subject no longer meets study criteria
|
0
|
1
|
|
52 Week (Long Term)
Withrawal of the consent by the subject
|
4
|
6
|
|
52 Week (Long Term)
Lost to Follow-up
|
2
|
2
|
|
52 Week (Long Term)
Non-Compliance
|
2
|
3
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
Baseline characteristics by cohort
| Measure |
SAXA + DAPA + MET
n=232 Participants
Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
|
SITA + MET
n=229 Participants
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
72 participants
n=5 Participants
|
74 participants
n=7 Participants
|
146 participants
n=5 Participants
|
|
Region of Enrollment
North America
|
114 participants
n=5 Participants
|
113 participants
n=7 Participants
|
227 participants
n=5 Participants
|
|
Region of Enrollment
Central America
|
46 participants
n=5 Participants
|
42 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (randomization) to Week 26Population: The Randomized Subjects data set consists of all randomized subjects who received at least 1 dose of double-blind study drug during the double-blind treatment period. Data in this data set were analyzed based on randomized treatment group, even if the treatment they received was different
Outcome measures
| Measure |
Saxagliptin + Dapagliflozin + Metformin Group
n=224 Participants
Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules
|
SITA + MET
n=219 Participants
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
Mean Change in HbA1c
|
-1.41 percentage (%)
Standard Error 0.0696
|
-1.07 percentage (%)
Standard Error 0.0719
|
SECONDARY outcome
Timeframe: week 26Population: randomized subjects
Outcome measures
| Measure |
Saxagliptin + Dapagliflozin + Metformin Group
n=224 Participants
Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules
|
SITA + MET
n=219 Participants
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%
|
37.3 Percentage of subjects
3.150
|
25.1 Percentage of subjects
2.871
|
SECONDARY outcome
Timeframe: Baseline (randomization) to Week 26Population: randomized subjects
Outcome measures
| Measure |
Saxagliptin + Dapagliflozin + Metformin Group
n=224 Participants
Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules
|
SITA + MET
n=219 Participants
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
Mean Change in Total Body Weight
|
-1.86 kg
Standard Error 0.2010
|
-0.51 kg
Standard Error 0.2078
|
SECONDARY outcome
Timeframe: Baseline (randomization) to Week 26Population: randomized subjects
Outcome measures
| Measure |
Saxagliptin + Dapagliflozin + Metformin Group
n=224 Participants
Saxagliptin 5-mg tablet +Dapagliflozin 10-mg tablet+Metformin background therapy +Placebo capsules matching the sitagliptin 100-mg capsules
|
SITA + MET
n=219 Participants
Placebo tablet matching the saxagliptin 5-mg tablet +Placebo tablet matching the dapagliflozin 10-mg table+Sitagliptin 100-mg capsules +Metformin background therapy
|
|---|---|---|
|
Mean Change in Fasting Plasma Glucose (FPG)
|
-31.9 mg/dl
Standard Error 2.538
|
-11.0 mg/dl
Standard Error 2.668
|
Adverse Events
SAXA + DAPA + MET
Serious events: 9 serious events
Other events: 112 other events
Deaths: 0 deaths
Sita + Met
Serious events: 13 serious events
Other events: 123 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAXA + DAPA + MET
n=232 participants at risk
Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
|
Sita + Met
n=229 participants at risk
Placebo tablet matching the saxagliptin 5-mg tablet+Placebo tablet matching the dapagliflozin 10-mg tablet+Sitagliptin 100-mg capsules+Metformin background therapy
|
|---|---|---|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
PALPITATIONS
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
MITRAL VALVE PROLAPSE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
VOMITING
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Injury, poisoning and procedural complications
POST LAMINECTOMY SYNDROME
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.00%
0/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
SEPSIS
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
Other adverse events
| Measure |
SAXA + DAPA + MET
n=232 participants at risk
Saxagliptin 5-mg tablet+Dapagliflozin 10-mg tablet+Placebo capsules matching the sitagliptin 100-mg capsules+Metformin background therapy
|
Sita + Met
n=229 participants at risk
Placebo tablet matching the saxagliptin 5-mg tablet+Placebo tablet matching the dapagliflozin 10-mg tablet+Sitagliptin 100-mg capsules+Metformin background therapy
|
|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
7.8%
18/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
5.2%
12/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Nervous system disorders
HEADACHE
|
5.6%
13/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
4.4%
10/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
4.3%
10/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.1%
7/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
INFLUENZA
|
3.4%
8/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
4.8%
11/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
BRONCHITIS
|
3.4%
8/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.0%
7/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.5%
8/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.9%
9/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Congenital, familial and genetic disorders
DYSLIPIDAEMIA
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
1.3%
3/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
SINUSITIS
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.87%
2/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Infections and infestations
GASTROENTERITIS
|
1.7%
4/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.2%
5/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.2%
5/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
0.44%
1/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Vascular disorders
HYPERTENSION
|
1.3%
3/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.5%
8/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.3%
3/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.1%
7/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.3%
3/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.6%
6/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.86%
2/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.6%
6/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
3.1%
7/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.2%
5/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Gastrointestinal disorders
GASTRITIS
|
0.43%
1/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.2%
5/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
|
Endocrine disorders
HYPERGLYCAEMIA
|
0.00%
0/232 • 52 weeks
Including Data After Rescue, Treated Subjects
|
2.2%
5/229 • 52 weeks
Including Data After Rescue, Treated Subjects
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI to provide AstraZeneca (AZ) with an opportunity to review/comment on drafts of publication and review final draft at least 30 days in advance of submission for publication or public presentation (15 days for an abstract or poster). If requested agree to delay submission or presentation for an additional period, not more than additional 90 days, to allow AZ to file a patent or application to preserve our rights in any intellectual property disclosed in the publication.
- Publication restrictions are in place
Restriction type: OTHER