Trial Outcomes & Findings for 18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D) (NCT NCT00666458)

Last Updated: 2010-04-15

Results Overview

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

822 participants

Primary outcome timeframe

Baseline, Week 18

Results posted on

2010-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Saxa + Met Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met Sitagliptin 100 mg capsules added on to open-label metformin
Overall Study STARTED	403	398
Overall Study COMPLETED	365	374
Overall Study NOT COMPLETED	38	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Saxa + Met Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met Sitagliptin 100 mg capsules added on to open-label metformin
Overall Study Adverse Event	8	7
Overall Study Withdrawal by Subject	5	4
Overall Study Lost to Follow-up	0	3
Overall Study Administrative reason by sponsor	1	1
Overall Study Incorrect enrollment	7	1
Overall Study Study specific discontinuation criteria	14	7
Overall Study Severe non-compliance to the protocol	1	1
Overall Study Safety reasons	1	0
Overall Study Medical history of anemia	1	0

Baseline Characteristics

18-week add-on to Metformin Comparison of Saxagliptin and Sitagliptin in Adult Patients With Type 2 Diabetes (T2D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saxa + Met n=403 Participants Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=398 Participants Sitagliptin 100 mg capsules added on to open-label metformin	Total n=801 Participants Total of all reporting groups
Age Continuous	58.77 years STANDARD_DEVIATION 10.14 • n=93 Participants	58.07 years STANDARD_DEVIATION 10.51 • n=4 Participants	58.42 years STANDARD_DEVIATION 10.32 • n=27 Participants
Sex: Female, Male Female	213 Participants n=93 Participants	196 Participants n=4 Participants	409 Participants n=27 Participants
Sex: Female, Male Male	190 Participants n=93 Participants	202 Participants n=4 Participants	392 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 18

Population: Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations.

Outcome measures

Outcome measures
Measure	Saxa + Met n=334 Participants Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=343 Participants Sitagliptin 100 mg capsules added on to open-label metformin
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 Baseline	7.68 Percent Standard Error 0.052	7.69 Percent Standard Error 0.047
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 Week 18	7.16 Percent Standard Error 0.052	7.07 Percent Standard Error 0.051
Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 Adjusted Change from Baseline	-0.52 Percent Standard Error 0.039	-0.62 Percent Standard Error 0.038

SECONDARY outcome

Timeframe: Week 18 (Last Observation Carried Forward)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement.

Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c \<= 6.5% at Week 18 (Full Analysis Set)

Outcome measures

Outcome measures
Measure	Saxa + Met n=399 Participants Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=392 Participants Sitagliptin 100 mg capsules added on to open-label metformin
Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18	26.3 Percentage of Participants	29.1 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 18 (Last Observation Carried Forward)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement.

Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value.

Outcome measures

Outcome measures
Measure	Saxa + Met n=397 Participants Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=392 Participants Sitagliptin 100 mg capsules added on to open-label metformin
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) Baseline	159.67 mg/dL Standard Error 2.280	160.22 mg/dL Standard Error 2.192
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) Week 18	149.04 mg/dL Standard Error 1.991	143.94 mg/dL Standard Error 1.864
Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) Adjusted Change from Baseline	-10.75 mg/dL Standard Error 1.455	-16.16 mg/dL Standard Error 1.464

SECONDARY outcome

Timeframe: Baseline, Week 18 (Last Observation Carried Forward)

Outcome measures

Outcome measures
Measure	Saxa + Met n=397 Participants Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=392 Participants Sitagliptin 100 mg capsules added on to open-label metformin
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) Baseline	8.86 mmol/L Standard Error 0.127	8.89 mmol/L Standard Error 0.122
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) Week 18	8.27 mmol/L Standard Error 0.111	7.99 mmol/L Standard Error 0.103
Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) Adjusted Change from Baseline	-0.60 mmol/L Standard Error 0.081	-0.90 mmol/L Standard Error 0.081

Adverse Events

Saxa + Met

Serious events: 7 serious events

Other events: 54 other events

Deaths: 0 deaths

Sita + Met

Serious events: 5 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Saxa + Met n=403 participants at risk Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=398 participants at risk Sitagliptin 100 mg capsules added on to open-label metformin
General disorders Chills	0.25% 1/403	0.00% 0/398
General disorders Ulcer Haemorrhage	0.25% 1/403	0.00% 0/398
Cardiac disorders Supraventricular Tachycardia	0.25% 1/403	0.25% 1/398
Gastrointestinal disorders Faecaloma	0.25% 1/403	0.00% 0/398
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.25% 1/403	0.00% 0/398
Injury, poisoning and procedural complications Fall	0.00% 0/403	0.25% 1/398
Metabolism and nutrition disorders Hyperglycaemia	0.25% 1/403	0.00% 0/398
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/403	0.25% 1/398
Metabolism and nutrition disorders Hypoglycaemic Unconsciousness	0.00% 0/403	0.25% 1/398
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.25% 1/403	0.00% 0/398
Respiratory, thoracic and mediastinal disorders Asthma	0.25% 1/403	0.00% 0/398
Vascular disorders Aortic Aneurysm	0.00% 0/403	0.25% 1/398

Other adverse events

Other adverse events
Measure	Saxa + Met n=403 participants at risk Saxagliptin 5 mg tablets added on to open-label metformin	Sita + Met n=398 participants at risk Sitagliptin 100 mg capsules added on to open-label metformin
Infections and infestations Urinary Tract Infection	6.9% 28/403	6.5% 26/398
Infections and infestations Influenza	6.7% 27/403	6.8% 27/398

Additional Information

Gerard Lynch

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place