Trial Outcomes & Findings for Saxagliptin Triple Oral Therapy (NCT NCT01128153)
NCT ID: NCT01128153
Last Updated: 2012-08-10
Results Overview
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
COMPLETED
PHASE3
257 participants
From Baseline to Week 24 weeks
2012-08-10
Participant Flow
Participants were recruited to the study from 35 centres in 6 countries (Australia, United Kingdom, Canada, Korea, India and Thailand). Participants were recruited between June 2010 and December 2010.
Participants were screened over 2 week period. 383 participants enrolled; 126 excluded (11 declined, 114 did not meet eligibility criteria, 1 lost to follow up).
Participant milestones
| Measure |
SAXAGLIPTIN
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
PLACEBO
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
128
|
|
Overall Study
Full Analysis Set
|
127
|
128
|
|
Overall Study
COMPLETED
|
113
|
113
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
SAXAGLIPTIN
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
PLACEBO
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Condition under investigation worsened
|
8
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Incorrect enrolment to study
|
2
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Developed discontinuation criteria
|
1
|
1
|
Baseline Characteristics
Saxagliptin Triple Oral Therapy
Baseline characteristics by cohort
| Measure |
SAXAGLIPTIN
n=129 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
PLACEBO
n=128 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.2 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 11.49 • n=7 Participants
|
57.0 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
70 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
BMI
|
29.4 kg/m2
STANDARD_DEVIATION 5.26 • n=5 Participants
|
29.1 kg/m2
STANDARD_DEVIATION 4.93 • n=7 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 5.09 • n=5 Participants
|
|
HbA1c
|
8.38 %
STANDARD_DEVIATION 0.856 • n=5 Participants
|
8.19 %
STANDARD_DEVIATION 0.832 • n=7 Participants
|
8.28 %
STANDARD_DEVIATION 0.848 • n=5 Participants
|
|
2-hour Postprandial Glucose
|
269.18 mg/dL
STANDARD_DEVIATION 76.814 • n=5 Participants
|
265.6 mg/dL
STANDARD_DEVIATION 69.713 • n=7 Participants
|
267.39 mg/dL
STANDARD_DEVIATION 73.220 • n=5 Participants
|
|
2-hour Postprandial glucose
|
14.94 mmol/L
STANDARD_DEVIATION 4.263 • n=5 Participants
|
14.74 mmol/L
STANDARD_DEVIATION 3.869 • n=7 Participants
|
14.84 mmol/L
STANDARD_DEVIATION 4.064 • n=5 Participants
|
|
Fasting Plasma Glucose
|
9.00 mmol/L
STANDARD_DEVIATION 2.626 • n=5 Participants
|
8.63 mmol/L
STANDARD_DEVIATION 2.130 • n=7 Participants
|
8.82 mmol/L
STANDARD_DEVIATION 2.393 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24 weeksPopulation: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=127 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=127 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
|
-0.74 percent
Interval -0.89 to -0.6
|
-0.08 percent
Interval -0.23 to 0.07
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=115 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=113 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
|
-11.66 mg/dL
Interval -23.38 to 0.07
|
5.08 mg/dL
Interval -6.45 to 16.6
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=115 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=113 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
|
-0.65 mmol/L
Interval -1.3 to 0.0
|
0.28 mmol/L
Interval -0.36 to 0.92
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=121 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=123 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
|
-5.28 mg/dL
Interval -12.67 to 2.11
|
2.62 mg/dL
Interval -4.47 to 9.71
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=121 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=123 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
|
-0.29 mmol/L
Interval -0.7 to 0.12
|
0.15 mmol/L
Interval -0.25 to 0.54
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle.
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
Outcome measures
| Measure |
Arm 1 - SAXAGLIPTIN
n=127 Participants
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
Arm 2 - PLACEBO
n=127 Participants
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
|
39 Participants
|
12 Participants
|
Adverse Events
SAXAGLIPTIN
PLACEBO
Serious adverse events
| Measure |
SAXAGLIPTIN
n=129 participants at risk
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
PLACEBO
n=128 participants at risk
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.78%
1/129
|
0.00%
0/128
|
|
Infections and infestations
Influenza
|
0.00%
0/129
|
0.78%
1/128
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/129
|
0.78%
1/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.78%
1/129
|
0.00%
0/128
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/129
|
0.78%
1/128
|
|
Hepatobiliary disorders
Hepatitis
|
0.78%
1/129
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Cartilage Injury
|
0.00%
0/129
|
0.78%
1/128
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/129
|
0.78%
1/128
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/129
|
0.78%
1/128
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/129
|
0.78%
1/128
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/129
|
0.78%
1/128
|
Other adverse events
| Measure |
SAXAGLIPTIN
n=129 participants at risk
Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
|
PLACEBO
n=128 participants at risk
Placebo tablet once daily for 24 weeks to be taken orally
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.78%
1/129
|
3.9%
5/128
|
|
Gastrointestinal disorders
Constipation
|
0.78%
1/129
|
2.3%
3/128
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
7/129
|
3.9%
5/128
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
4/129
|
0.00%
0/128
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
3/129
|
2.3%
3/128
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/129
|
3.1%
4/128
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
8/129
|
9.4%
12/128
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/129
|
2.3%
3/128
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/129
|
2.3%
3/128
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.7%
6/129
|
4.7%
6/128
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
4/129
|
6.2%
8/128
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.9%
5/129
|
5.5%
7/128
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
4/129
|
3.1%
4/128
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/129
|
2.3%
3/128
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.78%
1/129
|
3.1%
4/128
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.6%
2/129
|
3.1%
4/128
|
|
Nervous system disorders
Dizziness
|
2.3%
3/129
|
1.6%
2/128
|
|
Nervous system disorders
Headache
|
3.1%
4/129
|
2.3%
3/128
|
|
Nervous system disorders
Neuropathy Peripheral
|
2.3%
3/129
|
0.00%
0/128
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/129
|
2.3%
3/128
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
4/129
|
0.78%
1/128
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
2/129
|
2.3%
3/128
|
|
Vascular disorders
Hypertension
|
5.4%
7/129
|
1.6%
2/128
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At least 60 days prior to submission of any material for publication or presentation, PI shall provide Sponsor with such material for review. If requested in writing by Sponsor, PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of Sponsor's request.
- Publication restrictions are in place
Restriction type: OTHER