Trial Outcomes & Findings for Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes (NCT NCT01006590)
NCT ID: NCT01006590
Last Updated: 2012-01-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
286 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2012-01-19
Participant Flow
The study was conducted at hospital clinics and general practitioners. Patient recruitment started October 20, 2009 and was completed April 30, 2010
Screening, enrollment (2 weeks) and lead-in period (4 weeks). Main reason for not being randomised was due to renal function not meeting inclusion criteria. (Samples taken and analysed after enrollment into the study but prior to randomisation).
Participant milestones
| Measure |
Saxagliptin
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
139
|
|
Overall Study
COMPLETED
|
119
|
107
|
|
Overall Study
NOT COMPLETED
|
28
|
32
|
Reasons for withdrawal
| Measure |
Saxagliptin
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Study specific discontinuation criteria
|
16
|
23
|
|
Overall Study
Other
|
3
|
2
|
Baseline Characteristics
Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Saxagliptin
n=147 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=139 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.7 Years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
58.6 Years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
58.7 Years
STANDARD_DEVIATION 10.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksOutcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Absolute Change From Baseline in HbA1c at Week 24
|
-0.47 Percent (%)
Standard Error 0.06
|
-0.38 Percent (%)
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 24 WeeksProportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent
Outcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%
|
43.8 Percentage of patients
|
35.0 Percentage of patients
|
SECONDARY outcome
Timeframe: 24 WeeksProportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent
Outcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%
|
20.5 Percentage of patients
|
16.8 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksOutcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Change From Baseline to Week 24 in Fasting Plasma Glucose
|
-1.07 millimol/Liter
Standard Error 0.16
|
-1.14 millimol/Liter
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksOutcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Change From Baseline to Week 24 in Fasting Insulin
|
-1.9 microUnit/milliLiter
Standard Error 0.82
|
-2.3 microUnit/milliLiter
Standard Error 0.85
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksOutcome measures
| Measure |
Saxagliptin
n=146 Participants
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=137 Participants
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta
|
4.70 Percent (%)
Standard Error 3.01
|
2.34 Percent (%)
Standard Error 3.13
|
Adverse Events
Saxagliptin
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Metformin Uptitration
Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saxagliptin
n=147 participants at risk
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=139 participants at risk
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.68%
1/147
|
0.00%
0/139
|
|
Cardiac disorders
Atrioventricilar Block Second Degree
|
0.00%
0/147
|
0.72%
1/139
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
1/147
|
0.00%
0/139
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/147
|
0.72%
1/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.68%
1/147
|
0.00%
0/139
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.00%
0/147
|
0.72%
1/139
|
|
Hepatobiliary disorders
Cholecystitis
|
0.68%
1/147
|
0.00%
0/139
|
|
Nervous system disorders
Nerve Root Compression
|
0.68%
1/147
|
0.00%
0/139
|
|
Vascular disorders
Aortic Dissection
|
0.68%
1/147
|
0.00%
0/139
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/147
|
0.72%
1/139
|
|
Infections and infestations
Pneumonia
|
0.00%
0/147
|
0.72%
1/139
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/147
|
0.72%
1/139
|
Other adverse events
| Measure |
Saxagliptin
n=147 participants at risk
Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
|
Metformin Uptitration
n=139 participants at risk
Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
9/147
|
12.2%
17/139
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
8/147
|
1.4%
2/139
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.8%
10/147
|
2.2%
3/139
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60